Male contraception

Researchers from the University of North Carolina at Chapel Hill found that zapping the testicles of rats with ultrasound machines like the ones physical therapists use to treat muscle injuries, did away with sperm-producing cells. The most effective dosage was determined to be two 15-minute zap sessions, which sent rat sperm counts far below the range considered normal in fertile rats in just two week’s time.

While the test shows promise for an inexpensive, reliable and reversible birth control option, more research will be needed, of course, before the testicle zap test could be available for human men. But it does offer promise for a safer alternative for birth control, especially at a time when the safety of contraceptives are falling under closer review.

Birth control pills are by far the most popular form of hormone contraception, but they carry a remote risk for developing blood clots. Newer generations of birth control pills over the years have lowered that risk, but one of the latest varieties, those that contain the hormone drospirenone, have been shown in recent studies to put women at even greater risk for developing dangerous blood clots.

Pills that contain drospirenone include some of the top- selling brands such as Yaz and Yasmin.

Last month, a Food and Drug Administration (FDA) advisory panel fell short of recommending the pills be banned, opting instead to advise that stronger warnings be placed on the pills’ packages.

Source: ABC News

SOURCE: Yaz Lawsuit › Experimental contraceptive zaps sperm count in rats

Hillard’s apparent conflict of interest on the federal agency panel was noted by former FDA Commissioner Dr. David Kessler, who recently offered expert witness testimony as part of an ongoing class-action lawsuit against the pharmaceutical company claiming that Bayer over-promoted the benefits and understated the risks of Yaz. Kessler also said that Bayer had plans to talk with Hillard about the risk of blood clots.

Hillard was also featured in a 2010 Bayer Tactical Brief video designed “to illustrate patient counseling techniques on the safety of Yaz.”

Blood clots are potentially deadly medical problems that can lead to strokes, heart attacks or pulmonary embolism. All birth control pills carry a slight risk for blood clots, which is noted on the drugs’ safety packaging. However, recent studies show that pills containing the hormone drospirenone put women at greater risk for developing blood clots. Bayer’s Yaz and Yasmin contain drospirenone. Bayer also makes versions of the pills with folic acid, known by the brand names Beyaz and Sayfral. Generic versions are also available.

The recent studies prompted the FDA to undergo a review of the safety of drospirenone-containing pills. The agency’s advisory panel voted to recommend that stronger warnings be put on the pills’ packages. Hilliard and at least three other members of the 26-member panel were later found to have research or financial ties to Bayer or companies that make generic versions of the pills.

In light of panel members’ possible conflict of interest in the Yaz case, citizen watchdog group POGO (Project On Government Oversight) is calling for a revote.

Source: California Watch

SOURCE: Yaz Lawsuit › FDA panel member ‘well utilized’ by Yaz maker

The FDA panel was charged with reviewing studies that showed a newer generation of birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than other oral contraceptives with other hormones. Drospirenone-containing pills include Yaz and Yasmin, made by Bayer. The drug company also sells versions of the pills containing folic acid under the brand names Beyaz and Safyral. Generic versions are also available.

While all birth control pills carry a risk for blood clots, new studies have shown drospirenone-containing pills to be more dangerous. Blood clots are a serious and potentially deadly medical condition. If the clots break free, they can travel to the heart and cause heart attack, travel to the brain and cause stroke, or travel to the lungs and cause pulmonary embolism.

The FDA ordered a review of the pills based on these new studies. The panel fell short of recommending banning the pills, opting instead to put stronger warnings on the drug’s safety label.

Following the vote, POGO (Project on Government Oversight) discovered that three of the panel’s advisers had research or financial ties to Bayer. A fourth adviser had a connection to Teva Pharmaceuticals, maker of generic versions of the pills. All four of those advisers voted to keep the drugs on the market, noting that the benefits of the pills outweighed the risks.

“The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence,” POGO Executive Director Danielle Brian told Huffington Post. The organization argues that a revote on the panel’s recommendation is in the best interest of the consumer.

Source: Huffington Post

SOURCE: Yaz Lawsuit › Watchdog group pushes FDA panel to revote on Yaz safety

The order held at bay nine “bellwether trials” that would have paved the way for the mass settlement of more than 10,000 lawsuits against Bayer for its top selling birth control pills, Yaz and Yasmin. The lawsuits accuse Bayer of misleading women about the safety risks associated with its oral contraceptives.

Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. Since the drugs were introduced to the market, generic brands and other formulations of birth control pills containing drospirenone have entered the market.

All birth control pills carry a slight risk for blood clots, but new studies suggest that the risk is even greater with birth control pills that contain drospirenone. A Food and Drug Administration (FDA) expert panel recently reviewed the studies and recommended that the pills’ labels carry stronger warnings about the blood clot risk.

Yaz and Yasmin became the top selling birth control pills in the United States with a staggering $1.58 billion in sales in 2010.

Source: The Madison St. Clair Record

SOURCE: Yaz Lawsuit › First Yaz trial will be April 30 if mediation fails

The Project on Government Oversight (POGO), a non-partisan, non-profit government advocacy group, found that of the 26 advisers on the FDA panel, three had research or financial ties to Bayer, makers of the top selling oral contraceptives Yaz and Yasmin. All four of those panel members voted in favor of keeping drospirenone-containing pills on the market.

Drospirenone is a hormone that works like a diuretic. It is found in Yaz and Yasmin, as well as various generic brands. The drugs came under FDA review after recent studies that suggested the pills were more likely to cause blood clots than birth control pills made with other hormones.

This week, POGO sent a letter to the FDA asking for the pills to be reviewed again, this time by a new, better vetted, advisory panel. “The American public must be able to trust that the FDA and its advisory committees are making decisions based on science, not industry influence,” POGO Executive Director Danielle Brian said.

FDA advisory panels review studies and make recommendations to the federal agency. While the FDA generally follows the advice of its exert panels, it is not required to do so.

Source: MedPageToday

SOURCE: Yaz Lawsuit › FDA panel members had ties to Yaz maker

Combined birth control pills

Combined oral contraceptives contain two hormones – estrogen and progestin. They work by stopping ovulation and by making the lining of the uterus thinner. There are several hormone varieties of combined birth control pills.

The study wasn’t limited to a particular formulation; however, some birth control pills are also approved by the Food and Drug Administration (FDA) to treat acne, such as OrthoTri-cylclen, and another, Yaz, has been approved to treat the symptoms of PMDD, a more severe form of PMS.

The Swedish study on how combined birth control pills affect menstrual pain involved verbal multidimensional scoring, or VMS, during which women would rate their pain as none, mild, moderate, and severe. The study showed that one in three women moved down just one category in pain after taking the pills.

Combined birth control pills have long been believed to relieve pain associated with menstruation, and in some cases have been prescribed solely for the treatment of menstrual cramps, especially young women. But experts warn that the benefits of using birth control pills should be weighed against the risks.

For example, birth control pills carry a risk for life threatening blood clots. Yaz, which is approved for the treatment of PMDD as well as birth control and has become one of the most prescribed oral contraceptives in the country, has been associated with a higher risk for blood clots than older generation pills.

Menstrual pain is a frequently occurring condition affecting a large proportion of young women, but researchers say the study shows only limited evidence that oral contraceptives improve pain.

Sources:
MedPageToday
Arizona Health

SOURCE: Yaz Lawsuit › Combined birth control pills provide limited PMS pain improvement

It is already understood that a history of breast cancer in mothers, sisters and grandmothers increases the likelihood that a woman will develop breast cancer. Statistically, these women are nearly 300 percent more likely to develop the disease compared to women with no history of breast cancer.

The new study, conducted by R. Lodha and colleagues in LM Medical Collage and Research Centre in Bhopal, India, is based on data collected from central Indian women from October 2008 through August 2009. Researchers found that women who had a history of using oral contraceptives were 200 percent more likely to develop breast cancer compared to women who did not use birth control pills. They also found that women who never breastfed were 262 percent more likely to develop the disease.

“The findings of the present study suggests that positive family history of breast cancer and history of using (birth control pills) may be the epigenetic factors promoting the occurrence of breast cancer, while breast feeding reduces the possibility of acquiring breast cancer,” the researchers concluded.

The study contradicts other studies that suggest using birth control pills lowers women’s chances of developing cancer of the breast, ovaries or uterus.

A woman’s choice to use birth control pills – and which types of oral contraceptives – should be based on weighing the potential risks against the potential benefits. Using any type of birth control pill increases a woman’s risk for dangerous blood clots.

Newer studies show that a woman is at even greater risk with newer generation birth control pills that contain the hormone drospirenone. These pills include the top selling brands Yaz and Yasmin, as well as their generic equivalents.

Source: Food Consumer

SOURCE: Yaz Lawsuit › No breastfeeding plus birth control pills may increase risk of breast cancer

Missing data

Lead researcher Joseph Ross said drug companies that delay publishing these findings, or even deliberately hide trial data, are breaching their ethical duty. “The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine,” he said.

Data from these trials could provide vital information, such as evidence that a drug is dangerous. For example, Bayer faces lawsuits from women who say that the company was aware that its birth control pills Yaz and Yasmin put them at greater risk than other pills for suffering serious health problems, including blood clots, heart attacks, strokes and gallbladder damage. The company insisted that its oral contraceptives were no more dangerous than other pills. However, newly released studies show that the pills are more risky than older generation birth control pills.

In fact, during a Food and Drug Administration (FDA) advisory committee meeting reviewing the safety concerns associated with Yaz and Yasmin, the former FDA chief testified that Bayer withheld pertinent data on Yasmin and the increased risk for blood clots. (The committee recently recommended that stronger warnings be placed on the packages of Yaz and Yasmin, telling women that studies show the pills carry a greater risk for blood clots that can lead to serious health problems and even death.)

Yaz and Yasmin are among the top selling birth control pills in the United States and the United Kingdom; however, recent press about the drug’s link to blood clots has led to a drop in sales.

“Most clinicians assume that the complex regulatory systems that govern human research ensure that (clinical data) is relevant, reliable and properly disseminated,” Dr. Richard Lehman from Oxford University and the British Medical Journal’s Dr. Elizabeth Loder told the Daily Mail. “It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case.”

Sources:
Daily Mail
Bloomberg

SOURCE: Yaz Lawsuit › Drug companies may delay, withhold trial data from medical journals

Late last year, FDA advisory committees reviewed studies which suggested that birth control pills containing the hormone drospirenone put women at greater risk for blood clots than pills made with older-generation hormones. Blood clots are serious health problems because they can break loose and travel to the heart, lungs or brain causing serious complications or death.

Oral contraceptives that contain drospirenone are the top selling Yaz and Yasmin, as well as Safyral, Beyaz (all made by Bayer) and generics Gianvi, Loryna, Ocella, Syeda, and Zarah.

These claims have resulted in thousands of lawsuits against Bayer by women who say they were not adequately warned that using drospirenone-containing pills could put their life at risk.

The FDA committee fell short of recommending that the pills be banned, instead advising that stronger labels be placed on the pills.

The committee also recommended that stronger warnings be placed on the Ortho Evra birth control patch, made by Johnson & Johnson. Studies have linked the patch to high numbers of blood clots.

While many otherwise healthy women have suffered health problems as result of these contraceptives, experts say women with specific risk factors should probably avoid them altogether. This includes women with blood clotting disorders or a family history of blood clotting, smokers, and women over the age of 35.

Perhaps the best advice is to consider alternatives to birth control pills and patches. Options include the hormone shots and the increasingly popular intrauterine devices (IUDs), which are made in both hormone and non-hormone forms. And there are always more traditional methods, such as condoms, contraceptives sponges and diaphragms.

Source: Everyday Health

SOURCE: Yaz Lawsuit › Women should be aware of blood clot risk with birth control pills, patches

While hormone-based birth control pills and patches carry a risk for dangerous blood clots, studies have shown that the Ortho Evra patch can put users at an even greater risk. Blood clots can be fatal because they can create blockages in the lungs or blood vessels which can lead to heart attacks, strokes and even death.

In lieu of banning the patch, the panel recommended that the drug’s label be simplified so that users could better understand the blood clot risk, which studies show is as much as twice as that of birth control pills.

The panel also recommended that stronger warnings be placed on packages of newer generation birth control pills that contain the hormone drospirenone. Oral contraceptives in this class include the top selling brands Yaz and Yasmin, as well as generic equivalents.

Newer studies have shown that drospirenone-containing pills may put users at an even greater risk for blood clots than older generation pills.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

Sources:
Business Week
Beasley Allen Ortho Evra and Blood Clots

SOURCE: Yaz Lawsuit › FDA panel warns of elevated blood clot risk with patch, Yaz

Stronger warnings

Last month, a Food and Drug Administration (FDA) advisory panel reviewed data about the safety of a class of birth control pills that contain the hormone drospirenone, which includes the top-selling Yaz and Yasmin, both made by Bayer. The panel voted to recommend stronger warnings be placed on drospirenone-containing pills based on studies that showed the pills put women at greater risk for life-threatening blood clots compared to older generation oral contraceptives. Blood clots can break loose and travel to the lungs, heart or brain.

The FDA panel also recommended that safety labels on the birth control patch be rewritten so that the blood clot risk is easier to understand.

Also last month, for the first time, the U.S. Health Secretary overruled government scientists who wanted to make the morning-after pill available to women of all ages without a prescription.

The Planned Parenthood Federation of America said the media attention could make women afraid to use birth control. For example, when the blood clot risk with newer generation birth control pills was first publicized in Britain in 1995, many women stopped using contraception, which drove up the rate of unwanted pregnancies and abortions.

Source: MSNBC.com

SOURCE: Yaz Lawsuit › Blood clot warnings on birth control pills could impact user rates

There is no doubt that with all oral contraceptives there is a slight risk for blood clots. Bayer, maker of Yaz and a family of other drospirenone-containing pills such as Yasmin, Beyaz and Safyral, has consistently claimed its pills were no more as dangerous than other birth control pills.

However, newer studies have indicated the risk of drospirenone-containing pills may be as much as 74 percent greater than older generation hormones, such as levonorgestrel.

Blood clots, also known as venous thromboembolism (VTE), can break away and move to the lungs and cause respiratory distress, to the heart and cause heart attacks, or to the brain and trigger strokes – all conditions that can be deadly. The pills have also been associated with a greater risk for gallbladder damage.

Nearly half of the advisory panel charged with reviewing the safety of Yaz voted that the risks associated with the pills were greater than the benefits. But the slight majority of the panel gave credit to the drug’s other so-called benefits, including treating certain menstrual-related problems and moderate acne.

Some voters also raised concerns that the studies did not adequately take into account factors that could contribute to the development of blood clots such as body mass index, smoking, socioeconomic status and family history. The studies were also observational, not controlled.

The committee ultimately voted 21 to 5 that the labels on dropsirenone-containing pills do not adequately reflect the risk-benefit profile and recommended that a stronger warning should be placed on the pills. The FDA is not required to follow the advice of its committee members, but it most often does.

Source: CNN

SOURCE: Yaz Lawsuit › Why would FDA panel not ban Yaz over blood clot risk?

The study, released last month, puts the blood clot risk with drospirenone-containing pills at 43 to 65 percent greater when compared to pills with other types of hormones. The latest study is based on data from 330,000 Israeli women.

Previous research, involving 835,826 women ranging in age from 10 to 55 who were taking pills like Yaz, suggested the blood clot risk was as much as 74 percent greater with drospirenone pills compared to oral contraceptives containing older hormones.

All birth control pills carry a risk for blood clots, but the latest study provides more evidence that pills like Bayer’s Yaz and Yasmin may be even more dangerous. Blood clots can lead to serious complications such as strokes, heart attacks and even death. The pills have also been associated with gallbladder damage.

Other pills that contain drospirenone include Bayer’s Beyaz and Safyral. There are also numerous generic versions available.

Tens of thousands of lawsuits have been filed by women who say they have suffered serious injuries from the pills, and who say Bayer did not adequately warn them that using the pills could put their lives at risk.

A Food and Drug Administration (FDA) advisory committee recently recommended that stronger warnings be placed on the packages of oral contraceptives containing drospirenone.

Source: Beasley Allen Personal Injury Attorney

SOURCE: Yaz Lawsuit › New studies show increased risk of blood clots with Yaz

Yaz

Watson wants to take a bite out of the $173 million in sales Yaz has generated for the 12 months ended on September 30. The drug company is currently in a patent dispute with Bayer regarding Yaz.

Vestura joins others in this newer formulation of oral contraceptives that contain the hormone drospirenine. Others in this class include Yaz, Yasmin, Beyaz and Safyral.

An FDA advisory panel recently reviewed studies on the safety of drospirenone-containing pills that showed the pills appear to put users at greater risk for blood clots, heart attacks, strokes and even death. The pills have also been associated with gallbladder damage. The committee ultimately recommended stronger warnings be placed on the drugs’ packages. The FDA is not required to follow the advice of its advisory panels, but it usually does.

Bayer is currently embroiled in thousands of lawsuits over its family of drospirenone-containing pills from women who claim the drug company knew the drugs were dangerous but continued to sell them.

Source: WSJ

SOURCE: Yaz Lawsuit › FDA approves generic Yaz despite serious blood clot warnings

Sid Wolfe

The FDA cited “intellectual conflict of interest” when it pulled Wolfe’s voting power from the agency’s Drug Safety and Risk Management Advisory Committee. Public Citizen has previously warned women to avoid the pills because of the risk for life threatening complications.

The committee was reviewing a new study that suggested drospirenone-containing birth control pills put women at greater risk for blood clots than oral contraceptives with older hormones. Bayer, makers of Yaz and Yasmin, has continually argued that its pills are no more dangerous than other birth control pills.

Bayer is being sued by thousands of women who claim to have suffered injuries, or the families of those who they claim died as a result of taking Yaz and Yasmin. Blood clots can lead to serious complications including strokes, heart attacks and death. The pills have also been linked to gallbladder damage.

The panel ultimately recommended that stronger warnings about the risk of blood clots be placed on the birth control pills. The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

Source: All Gov

SOURCE: Yaz Lawsuit › FDA panel member stripped of voting rights in Yaz-blood clot safety review

Bayer

The claim was made by former FDA commissioner David Kessler, who claimed Bayer did not include an analysis that demonstrated an increase in the U.S. reporting rate for blood clots in a 2004 review of Yasmin’s safety to the federal agency. The report also didn’t include an earlier draft opinion by Bayer researchers that identified a difference in blood clot rates for Yasmin compared to other oral contraceptives. Instead, he claimed Bayer chose to market Yasmin for the treatment of premenstrual syndrome, a condition for which the drug was not approved.

The report was part of an expert panel’s analysis of data that suggested that Yasmin and other birth control pills containing the hormone drospirenone put women at greater risk for life threatening blood clots than older oral contraceptives. Other pills that contain drospirenone include Bayer’s Yaz, Beyaz and Safyral. Generic varieties are also marketed in the United States.

Bayer is currently embroiled in thousands of lawsuits from women who say they were not adequately warned that using drospirenone-containing birth control pills could put them at risk for blood clots, heart attacks, strokes and even death. The drug company has insisted its birth control pills are no more as dangerous as other oral contraceptives.

The expert panel pored over data for nine hours, eventually voting to recommend that the FDA place stronger warnings for the risk of blood clots on the drug’s packaging. The agency is not required to follow the advice of its expert panels, but it usually does.

Source: Bloomberg

SOURCE: Yaz Lawsuit › Report: Bayer withheld data on blood clot risk with Yasmin

Yaz, made by Bayer, is a newer generation birth control pill that contains the manmade hormone drospirenone, which is designed to mimic the naturally occurring female hormone progesterone. The pill was heavily promoted as an oral contraceptive that could also clear up acne and remedy the bothersome symptoms of premenstrual syndrome. It soon became the nation’s top selling birth control pill.

Bayer has since been fined for making such claims and ordered to run revision ads. Other pills that contain drospirenone include Bayer’s Yasmin, Beyaz and Safyral. Generic varieties are also available.

All birth control pills have a slight risk for blood clots. But recent studies have suggested that the risk of blood clots with drospirenone is higher. Bayer currently faces thousands of lawsuits from women who say they were not adequately warned that using Yaz and pills like it could put them at risk for dangerous blood clots that can lead to stroke, heart attack and death.

The most recent studies convinced the FDA that the safety of drospirenone-containing pills needed a closer look.

Panelists spent more than nine hours discussing the data on blood clot risk with drospirenone pills compared to those with older hormones. While there was discrepancy on the authenticity of the studies, nearly the entire panel voted that the label should clearly state the potential for potentially fatal blood clots.

The fate of Yaz and its similar birth control pills now falls on the FDA. The agency is not required to follow the advice of its panels, but it usually does.

Source: Boston.com

SOURCE: Yaz Lawsuit › FDA panel recommends stricter blood clot warnings on Yaz

The new guidelines are based on data from a group of recent studies, and reveal the dangers of oral contraceptives immediately following birth may be much higher than previously thought. The risk of blood clots in women of reproductive age in general is low, but the risk increases significantly when these women are pregnant and for the first six weeks following delivery.

Estrogen-containing birth control pills already carry a slight risk for blood clots, but recent studies show that newer generations of birth control pills, such as Yaz and Yasmin that also contain the hormone drospirenone, may put women at even greater risk for developing blood clots. Yaz and Yasmin, made by Bayer, are among the most widely used birth control pills in the United States and Canada. The company currently faces more than 2,000 lawsuits from women that claim they were not adequately warned by Bayer that taking Yaz and Yasmin could put their lives at risk.

Source: MSNBC

SOURCE: Yaz Lawsuit › Birth control pills increase stroke risk after delivery

The story lauded contraceptives for their preventative benefits: “Women on birth control see a 60 percent decreased risk of ovarian cancer. There is also a 50 percent reduction in uterine cancer which has 37,000 new cases each year.” Yet, the story fails to mention the serious risks associated with Yaz, a newer generation birth control pill that combines the hormones ethinyl estradiol and drospirenone, as well as other birth control pills.

All birth control pills carry a slight risk for blood clots. But new studies suggest that some pills, especially those containing drospirenone, may put women at even greater risk for developing the condition. Blood clots are serious health problems that can lead to heart attacks, strokes, and even sudden death.

Last month, based on new studies published in the British Medical Journal, the FDA and Health Canada announced they were reviewing studies on the health risks associated with Yaz, Yasmin (also made with ethinyl estradiol and drospirenone) and their generic equivalents. Early reviews of the studies comparing oral contraceptives containing drospirenone with pills containing another progestin, indicate that drospirenone-containing pills may put women at greater risk for blood clots.

Bayer, the makers of Yaz and Yasmin, have held firm on the message that their pills are no more dangerous than other oral contraceptives. However, the company was ordered by the FDA this summer to add stronger blood clot warnings on the safety labels of both Yaz and Yasmin. Bayer also faces about 2,000 lawsuits from injured women who allege that they were not properly warned by the company that the pills could be deadly.

Still think the benefits of an acne-free face outweigh the risk of life-altering blood clots?

Source: Style Bistro

SOURCE: Yaz Lawsuit › Are birth control pills for acne treatment a good idea?

While the new Health and Human Services guidelines will make contraception affordable for all insured women, it also raises the importance for women to understand the risks and benefits of using birth control. Pharmaceutical companies use advertising to promote the benefit of their drugs, and the Food and Drug Administration (FDA) requires those advertisements to include possible side effects.

This consumer-targeted marketing has resulted in patients asking their doctors for specific drugs by name. The tactic worked such wonders for Bayer when it launched its birth control pill Yaz that the pill became the most prescribed oral contraceptive in the county.

Unfortunately, the drug company was cited for running ads that overstated the benefits of Yaz and didn’t clearly explain the possible life threatening risks associated with the pills. Bayer was ordered to rerun a series of ads explaining that, like all forms of birth control, Yaz puts women at slight risk for blood clots that can lead to heart attack, stroke, and death.

As the top-selling birth control pill in the country, Yaz was also creating another stir. An unusually high number of blood clots in women who were using the pills were being reported, which lead researchers to conduct a study comparing the hormones in Yaz to those in older generation birth control pills. They found that Yaz put women at greater risk of developing blood clots.

The study has prompted the FDA to conduct an ongoing review of data. The agency says it will offer a recommendation once all information has been reviewed.

Source: CNN

SOURCE: Yaz Lawsuit › Birth control soon to be free to all insured women

While the drug has yet to be approved for use in the United States, the possibility of a male birth control medication is creating a buzz. Researchers are already testing various contraceptive pills, patches, creams, and implants on men, and it is strongly believed that a male birth control pill could be available in the United States within 5 to 7 years, and implants could hit the market even sooner.

Researchers say data shows that contraceptives that combine progestin and androgen are safe, effective, inexpensive and reversible. However, proof of the drugs’ initial safety profile will be determined when clinical trials are completed.

Hormone birth control for women is known to slightly increase the risk for blood clots, which can lead to more serious problems such as heart attacks, strokes, and even death. Some studies suggest that a newer generation of pills – those that contain the hormone drospirenone – put women at even greater risk for blood clots. Those pills include the brands Yaz, Yasmin, Ocella, Beyaz, and Safyral, as well as their generic equivalents.

The male contraceptives are currently being tested in China, but researchers say they hope to conduct clinical trials in the United States within the next two years.

Sources:
Smart About Health
MSNBC

SOURCE: Yaz Lawsuit › Male birth control drugs may soon reach U.S. market

Generic drugs are what the Food and Drug Administration calls “copies of brand name drugs that have exactly the same dose, intended use, side effects, route of administration, risks, safety, and strength as the original drug.” However, the generic version, by law, is not entirely the same. It may have different colors or inactive ingredients. About half of all generic drugs are produced in the same plants used to manufacture the brand name drugs.

Yaz contains 3mg drospirenone and 20 mcg of ethinyl estradiol. Bayer offers the same formulation in Beyaz, a birth control pill that also contains the B vitamin folic acid. Generic versions of Yaz made by other manufacturers include Gianvi and Loryna.

Yasmin contains 3mg drospirenone and 30 mcg of ethinyl estradiol. Bayer also offers a folic acid-fortified version of Yasmin known by the brand name Safyral. Bayer also offers a generic Yasmin by the name of Ocella. Syeda and Zarah are more generic brands of Yasmin sold by other companies.

While all birth control pills put women at risk for blood clots, new studies show that drospirenone-containing pills put women at even greater risk. This includes Yaz and Yasmin, but also the numerous generic brands. Using a generic version of a medication does not mean, if you have been injured, that you are not eligible for compensation.

However,  a recent Supreme Court ruling determined makers of generic drugs are not required to warn patients if they receive reports of new side effects from the drugs. This ruling can protect generic drug makers from being sued under state liability laws for failing to warn patients of these new dangers. If you have been injured by a generic drug, it is important to talk to your lawyer about how this ruling may affect your rights to justice.

Beasley Allen Law Firm is currently investigating cases of women who have suffered blood clots, heart attacks, strokes or gallbladder damage after using any drospirenone-containing birth control pill.

Source: WebMD

SOURCE: Yaz Lawsuit › Generic versions of Yaz, Yasmin just as dangerous as brand name pills

The Yasmin family of birth control pills include Yaz, Beyaz and Safyral. All of these “four sisters” of contraceptives contain a combination of the hormones drospirenone and ethinyl estradiol. The pills have come under fire in recent weeks after the Food and Drug Administration (FDA) announced that it was reviewing studies that linked drospirenone-containing pills to a greater risk for blood clots. Blood clots can cause heart attacks, strokes, pulmonary embolism, and even sudden death.

Following the announcement Friday that the European Patent Market had pulled the patent on Yasmin, Bayer released a statement: “A decision on possible next steps will be taken by the company after studying the reasons for the decision.”

While the patent revocation begins immediately, there is no word yet how soon competitors will seek to put copycat versions on the market.

Despite competition and bad press about Yaz and Yasmin lawsuits filed on behalf of women who have been injured by the pills, the drug company reported global annual sales of $1.1 billion in 2010.

Source: Reuters

SOURCE: Yaz Lawsuit › Bayer loses European patent for Yasmin

Yaz and Yasmin are made by Bayer, which heavily marketed the pills not only as a contraceptive, but also as a treatment for acne and the symptoms of premenstrual syndrome. The pills became the top selling oral contraceptives in the United States and Canada.

As women were asking their doctors for the pills by name, the FDA and Health Canada were receiving reports of serious injuries and deaths in young women who took Yaz and Yasmin. Soon, lawsuits began mounting against Bayer from women who said they were never warned that taking the pills could put their lives at risk.

One such lawsuit was filed by the family of 18-year-old Michelle Pfleger. Michelle died from cardiac arrest after a blood clot lodged in her lungs. The young woman was using Yaz at the time. Bayer insists its pills are no more dangerous than other birth control pills.

Both the FDA and Health Canada are investigating the health risks associated with Yaz and Yasmin, and say they will take appropriate action as necessary once their reviews are complete.

SOURCE: Yaz Lawsuit › Studies show Yaz, Yasmin cause more blood clots

One answer is the Lady-Comp Fertility Monitor. The device uses a thermometer attached to a small monitor with a digital display. Users simply take their temperature orally each morning before they get out of bed. The device tracks the basal temperature, then learns and analyzes each woman’s unique cycle to indicate which days she is most likely to conceive. When used correctly and regularly, the device is 99.3 percent accurate.

Lady-Comp flashes a green light when you are not fertile, red if you are, and yellow if the device does not have enough information from previous readings to determine if it is safe to have sex without getting pregnant. Obviously, the device also can help women who are trying to conceive to get pregnant.

Lady-Comp uses no hormones, so it is safe. At $485, the cost sounds steep. But it also has a two-year manufacturer’s warranty, which averaged out, may be less expensive than birth control pills or products.

Sources:
NaturallyForHer.com
TheHairPin.com

SOURCE: Yaz Lawsuit › Yaz lawsuits leave women looking for safer birth control options

All birth control pills carry a slight risk for blood clots, but critics have long argued that Yaz and Yasmin put women at even greater risk. Both Yaz and Yasmin are made by Bayer Healthcare and contain the hormone drospirenone.

Health Canada’s announcement comes just days after the U.S. Food and Drug Administration (FDA) said it was keeping a watchful eye on two recent studies published in the British Medical Journal that compared the blood clot risks with drospirenone-containing birth control pills to pills that contained another popular birth control hormone known as levonorgestrel.

Birth control pills that contain drospirenone include Bayer’s Yaz, Yasmin, Beyaz and Safyral, as well as generics Ocella, Gianvi, Loryna, Syeda, and Zarah. Bayer has maintained that its pills are no more dangerous than other birth control pills; however, the pharmaceutical company faces thousands of lawsuits from women or their families who say that their drospirenone-containing pills caused them serious injuries such as blood clots, strokes, heart attacks, gallbladder damage, and even death.

Both Health Canada and the FDA say they will review all available information to fully assess the risk of blood clots with drospirenone-containing pills and will take appropriate action as necessary once the review is complete.

Sources:
680 News
FDA

SOURCE: Yaz Lawsuit › Health Canada reviewing data linking Yaz to greater risk of blood clots

Perhaps another attractive feature of IUDs and implants is that they may offer women a safer alternative to birth control pills. Most forms of birth control that use hormones carry a risk for blood clots, which can be life threatening. Birth control pills have blood clot warnings on their safety packaging. Recently, the Food and Drug Administration (FDA) issued a new warning that oral contraceptives containing drospirenone, such as the popular Yaz and Yasmin, may put women at even greater risk for blood clots, which can lead to heart attack, stroke and sudden death.

Studies have shown that Yaz and Yasmin are most popular among young women. However, the new study on contraceptive methods showed the biggest gains in recent years were among women younger than 24 and older than 35, as well as women in higher income brackets. Women who have already given birth were also more likely to choose IUDs and implants over birth control pills.

Source: Los Angeles Times

SOURCE: Yaz Lawsuit › More women choosing IUDs and implants over birth control pills

The studies referenced by the FDA looked at VTE rates in women using birth control pills containing drospirenone compared with women taking pills containing levonorgestrel. Data showed that the risk for venous thromboembolism, or pulmonary embolism, is as much as two to three times greater with drospirenone-containing pills than with levonorgestrel-containing pills.

Bayer launched its blockbuster birth control pill Yaz with a huge marketing campaign that claimed it could conquer symptoms of premenstrual syndrome and clear up acne. The FDA fined Bayer for overstating the benefits of the drug and downplaying the risks, including the risk for blood clots.

Women began asking their doctors for Yaz by name, making it the most prescribed birth control pill in the country. The success of Yaz was only slightly hampered by a series of ads Bayer was forced by the FDA to run that clearly stated the risks associated with the pill. It wasn’t until reports of deaths and serious injuries in women who used Yaz that the public began to take notice.

Bayer has defended its oral contraceptives, arguing they are no more dangerous than other birth control pills. The new studies suggest otherwise. Bayer now faces thousands of lawsuits from women and their families who say they were not adequately warned of the risks associated with the pills, including blood clots (including VTE), heart attacks, strokes and sudden death.

The FDA recommends women who have questions about their oral contraception contact their doctors. If they experience any of the following symptoms of VTE to seek medical help immediately – persistent leg pain, severe chest pain, sudden shortness of breath.

Women who smoke and are older than 35 years of age should not take combination birth control pills because they increase the risk of serious cardiovascular events, including blood clots.

Source: FDA

SOURCE: Yaz Lawsuit › FDA warns of elevated blood clot risk in Yaz birth control pills

Cummins believes it was her daughter’s birth control pills, which she also took for the treatment of acne, that caused her death. She has filed suit against the Bayer Corp., makers of the birth control Yaz, and several of its divisions. The lawsuit was filed as part of a national class-action lawsuit against the makers of Yaz.

The lawsuit states that Bayer “knowingly and falsely represented that Yaz was fit to be used for the purpose for which they were intended, when in fact the drugs were defective and dangerous.” It alleges that Bayer and its partners concealed the dangers of their drugs, neglected to warn the public of those dangers, misrepresented the drugs and violated consumer protection laws.

All birth control pills carry warnings of blood clots on their safety labels, but studies show that the formulation of hormones in Yaz, drospirenone and ethinyl estradiol, puts users at even greater risk for blood clots, which can lead to pulmonary embolism, deep vein thrombosis, heart attack, stroke and sudden death.

Bayer has maintained that its popular oral contraceptive is no more dangerous than other birth control pills, and promises to fight the allegations. “Bayer will defend itself vigorously against these lawsuits,” the company said in a statement.

Source: The Times News

SOURCE: Yaz Lawsuit › Mother files lawsuit against Yaz on behalf of deceased daughter

“This new research may muddy the waters more,” Dr. Joanna Longstaffe, clinical director of the Independent General Practice told Wales Online. “Brain aneurysms are very rare conditions, so protection is never going to have a huge impact and convince someone (to use the drug).”

The study suggests that the added estrogen in birth control pills, as well as in hormone replacement therapy (HRT), helps protect the blood vessels in the brain. However, birth control pills have been linked to an increased risk for blood clots, strokes and heart attacks.

In fact, recent studies show that one of the most popular birth control pills among young women, Yaz, puts women at even greater risk for blood clots than other types of oral contraceptives. HRT is also linked to an increased risk for breast cancer and other deadly conditions.

For the study, doctors interviewed 60 women with intact brain aneurysms and compared them with more than 4,600 women from the general population. Women with the brain aneurysms were significantly less likely to have taken oral contraceptives or HRT during their lives. They also had an earlier average age of menopause. Estrogen levels drop significantly when a woman reaches menopause. Women are also more likely to develop brain aneurysms after the age of 40, and the affected blood vessel is most likely to rupture between the ages of 50 and 59.

Dr. Longstaffe said that young women considering birth control seem less concerned about the potential risks associated with them, and may be less concerned about the benefits. “They see themselves as more immortal,” she added.

SOURCE: Yaz Lawsuit › New study may leave women confused about safety of birth control

According to researchers, both men’s and women’s preferences in partners change when a woman is ovulating. This was tracked in various studies by gauging women’s responses to photographs of different men or interviewing women about their feelings for men over several weeks. The studies show that when women ovulate they are more attracted to more masculine men with greater facial symmetry, more muscle tone, a masculine voice and more dominate behaviors. From an evolutionary perspective, these traits indicate that men are more fertile and have better genes for offspring.

When women use contraceptives, such as birth control pills, patches or injections, they do not ovulate, suggesting they are less likely to be attracted to more masculine men. Researchers suggest that this may cause problems because it masks a woman’s natural ability to detect genetic diversity and overall genetic health.

While researchers say there is not enough evidence to draw any formal conclusions, it does add fuel to the argument that hormone-based contraception may not be the best alternative for some women. Birth control pills, patches and injections have often been in the spotlight for their dangerous side effects, including blood clots that can cause heart attacks, strokes and sudden death.

Thousands of lawsuits have already been filed over one of the more popular birth control pills, Yaz, by women who claim they were not warned that the pill could put them at serious harm.

Source: Wall Street Journal

SOURCE: Yaz Lawsuit › Could birth control pill affect your preferences for partners?

National Teen Pregnancy Prevention Month (NTPPM), recognized throughout the month of May, aims to increase public awareness of teenage pregnancy and help young people develop responsible and healthy attitudes about sexuality in order to enhance decision-making skills that lead to positive life choices.

This philosophy is also supported by the Centers for Disease Control, which believes that success in preventing teen pregnancies and births requires a sustained commitment to meet the complex challenges facing the nation’s youth. As part of this effort, the CDC supports initiatives that include ensuring that sexually active teens have access to effective and affordable contraceptives.

This open-minded approach has helped drive the teen pregnancy rate down by almost a third since the beginning of the 1990s.

Contraceptive options vary, but a new study by Thomson Reuters shows that more teenagers are using birth control pills than ever before, and the pill they most often turn to is Yaz. The popularity of this pill, especially among young women, could arguably be blamed on the early marketing of the drug.

Yaz was touted to help knock out irritability and moodiness caused by premenstrual syndrome (PMS) and help clear up acne. Yaz’s maker, Bayer, was forced to run a series of clarification ads that clearly stated its benefits (the drug can help symptoms of the more serious premenstrual dysphoric disorder, or PMDD, and not PMS) and stating the drug’s risks (blood clots, heart attacks, strokes and sudden death).

While Bayer argues that Yaz is no more dangerous than other birth control pills, some studies suggest that the combination of hormones in Yaz is more dangerous than other birth control pills.

While birth control can help prevent unwanted pregnancies among teens, these young woman should also consider which brand of pill they are taking as some, such as Yaz, may be putting them at even greater risk for serious side effects.

Sources:
Pregnant Teen Help
CDC
Advocates for Youth
Beasley Allen Yaz Lawsuit

SOURCE: Yaz Lawsuit › May is National Teen Pregnancy Prevention Month

It’s time women put the burden of contraception on the men.

A team of Indian scientists is working to do just that – develop a birth control method for men. This experimental contraceptive is reversible and far less invasive than a vasectomy. It works by inhibiting sperm with a tiny electrically charged polymer inserted into a man’s testicles. When negatively charged sperm pass by the polymer, their cell membranes rupture and the tails are damaged. This cripples the sperm and leaves them unable to fertilize. The device reportedly does not inhibit libido nor does it diminish sperm count.

The device is still in the testing phases and effectiveness is still being determined. Researchers will also have to gauge whether the device is linked to any unwanted pregnancies or birth defects. At the very least, it offers a new alternative for men who are willing to step up and take responsibility for quelling unwanted pregnancies.

SOURCE: Yaz Lawsuit › Scientists working on birth control device for men

A Swiss appeals court has recently rejected Bayer’s request to punish a Swiss television station that reported there were about 190 deaths associated with Yaz and Yasmin in the Food and Drug Administration (FDA) database of adverse reactions. The database includes both confirmed and unconfirmed drug reports, and Bayer argued that it was not a true indicator of how dangerous the drug really is.

Yet, thousands of lawsuits levied against Bayer by women and their family members injured or killed after using the pills speak otherwise.

All birth control pills carry a risk for blood clots, but lawsuits contend that Yaz and Yasmin, both of which contain the hormones ethinyl estradiol and drospirenone, put women at even greater risk for blood clots. The disorder can lead to heart attacks, strokes and sudden death. Some lawsuits allege that Yaz and Yasmin also can damage the gallbladder, requiring surgery. Bayer faces more than 2,000 lawsuits over injuries and deaths caused by Yaz and Yasmin.

Bayer remains unwavering in its defense of its popular oral contraceptives. While the pharmaceutical company can’t fight the claims made in the U.S., it recently took on Swiss TV, alleging that the station’s report on deaths associated with the pills were “manipulative” and by reporting the story the station breached its “statutory requirement of factual accuracy.” Bayer first lost a ruling in lower court and earlier this month lost an appeal to a Swiss federal court on the basis that while the news story contained critical viewpoints, those views were correctly identified as such.

SOURCE: Yaz Lawsuit › Bayer loses case to silence media reporting dangers of Yaz, Yasmin

Bayer

“Given the already large and robust scientific body of evidence, in Bayer’s opinion, these studies do not change the overall assessment about the safety of Bayer’s oral contraceptives,” the company said in a statement.

Yaz and Yasmin are considered “fourth generation” birth control pills and use the hormones ethinyl estradiol and drospirenone. Bayer heavily marketed the pills, even touting Yaz as a cure-all of sorts for bothersome PMS symptoms and acne. The Food and Drug Administration ordered Bayer to rerun the ads, toning down its PMS claims (the drug was approved to also help ease symptoms of the more serious premenstrual dysphoric disorder, PMDD, but not PMS) and specifically outlining the risks associated with the pills, including the risk for life threatening blood clots.

Bayer has since been slapped with lawsuits from women and their families who have suffered from blood clots, heart attacks, strokes, gallbladder damage, and even death after using the pills. Bayer has long argued that Yaz and Yasmin are no more dangerous than other birth control pills.

All oral contraceptives carry a risk for blood clots, and lawsuits have maintained that Bayer’s pills put women at even greater risk. Previous studies that suggested as much were dismissed by Bayer. But two new studies back up plaintiffs’ claims, showing women who took contraceptives with drospirenone had more than twice the risk of developing blood clots than women on a hormone used in older generation pills, levonorgestrel.

Bayer still refuses to accept the blame. According to its statement, “Bayer’s assessment, (of the studies) based on its review to date, is that the manner in which the authors applied the study methodology reported in these two publications show significant flaws and the databases used provide less reliable conclusions than are available from existing scientific evidence around the risk of developing venous thromboembolism (VTE), or blood clots, with combination oral contraceptives (COCs).”

SOURCE: Yaz Lawsuit › Bayer dismisses new studies showing higher blood clot risk with Yaz, Yasmin

Bayer

Levonorgestrel is a progestogen that is used in both combination hormone pills and progestogen-only formulations. It is known by the brand names Escapelle, Plan B, Levonelle, NorLevo, Postinor-2, i-pill, Next Choice, and 72-HOURS. It is also the active ingredient in the Mirena-brand intrauterine device (IUD).

Blood clots have always been a risk factor with birth control pills, but mounting lawsuits against Bayer argue that Bayer’s formulation of drospirenone and ethinyl estradiol in Yaz and Yasmin puts women at greater risk. The same formulation of hormones is also in the generic oral contraceptive Ocella, as well as Bayer’s newly introduced folic acid-fortified pills Bayaz and Safyral.

Researchers from the Boston Collaborative Drug Surveillance Program at Boston University School of Medicine studied about 900 women on birth control since 2002. The blood clot risk for women taking Yaz or Yasmin was 30.8 per 100,000 person-years. Women on pills containing levonorgestrel had a rate of only 12.5 per 100,000 person-years.

Most alarming, researchers also found that women younger than 30 who used Yaz or Yasmin were at even greater risk for blood clots than women on second-generation pills. These young women had an incidence rate of 24.8 per 100,000 compared to only 5.39 per 100,000 if they took pills containing levonorgestrel.

SOURCE: Yaz Lawsuit › Young women at even greater risk for blood clots with Yaz, Yasmin

Drospirenone is a hormone that works like a diuretic. It is used in combination with another hormone, ethinyl estradiol, in Bayer HealthCare’s Yaz and Yasmin. Bayer recently released Beyaz and Safyral, two more birth control pills identical to Yaz and Yasmin, respectively, but with added folate. There are also generic versions of Yaz and Yasmin available, such as Ocella.

Diuretics can cause significant problems with the gallbladder that in some cases can lead to gallbladder removal. Some studies suggest that drospirenone can also increase potassium levels in the blood and lead to hyperkalemia, a condition which causes heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death, heart attacks, or strokes.

Bayer has long fought allegations that its popular birth control pills can put women’s lives at risk, but with more than 2,000 lawsuits filed against the company from women who say they were harmed by the pills, Bayer’s defense looks weak.

The new study was funded by the Fonds de la recherché en sante du Quebec, a government-financed research agency, and is in the current issue of the Canadian Medical Association Journal.

SOURCE: Yaz Lawsuit › Yaz, Yasmin puts women at greater risk for gallbladder damage

The interim data comes from a large, prospective, observational cohort safety study on the increased risk of venous thromboembolism (VTE), or blood clots, in women who use birth control pills. The study was funded by Bayer HealthCare Pharmaceuticals Inc., makers of Yaz, one of the most popular brands of birth control pills.

Blood clots are a potential side effect for women who use combination birth control pills. But Bayer’s Yaz and its sister pill, Yasmin, have come under fire in recent years for advertisements that the Food and Drug Administration (FDA) said overstated the drug’s benefits and downplayed its risks.

Those criticisms were compounded when the pharmaceutical company was later hit by thousands of lawsuits from women or their family members who claimed that Yaz and Yasmin put them at even greater risk for serious health problems including blood clots, heart attacks, strokes, gallbladder damage, and even death. The lawsuits claim Bayer never fully warned women that using Yaz and Yasmin could potentially kill them.

Bayer has been quick to dismiss the charges against it, arguing that Yaz and Yasmin are no more dangerous than other birth control pills, calling blood clots a “well-established risk in women who use combination oral contraceptives (COCs).’” Bayer says it was important for the company to take a lead in the studying and communicating of the risks and benefits of combination birth control pills.

“The new information is helpful because while healthcare providers have long known about the risk of VTE associated with COCs, there was little information to indicate that there was an increased risk in women restarting COCs after a four week or greater period of non-use. This new information should provide both healthcare providers and women who choose a COC for contraception with additional information when making the decision to implement a pause in their COC routine,” said Leo Plouffe, MD, Vice President, US Medical Affairs, Women’s Healthcare, Bayer HealthCare Pharmaceuticals.

SOURCE: Yaz Lawsuit › Women more at risk of blood clots during first six months on ‘The Pill’

The data involved more than 3 million women from 2002 to 2009. The women ranged in age from 13 to 33 with at least six months of enrollment in insurance and prescription drug coverage. The study found that 18 percent of teenage girls ages 13 to 18 filled prescriptions for birth control pills in 2009, up year after year since 2002. This was a 50 percent increase among commercially insured teenagers and a 29 percent increase among teenagers on Medicaid. The No. 1 choice in birth control pills among teenaged women was Yaz.

When Yaz was first approved for marketing in the United States it was touted as more than for pregnancy prevention. Bayer’s ads said the oral contraceptive could quell irritability caused by premenstrual syndrome (PMS) and manage breakouts of acne. It wasn’t long before women began asking for the pill by name, and it became the top selling birth control pill in America.

But the Food and Drug Administration (FDA) soon caught wind of those ads, and ordered Bayer to run a series of commercials to clarify that the pill was not approved for PMS, but for the more serious premenstrual dysphoric disorder, or PMDD. Bayer was also told to clearly state the risks associated with the drug, including the risk for blood clots, heart attacks, strokes and gallbladder damage.

While all birth control pills carry a risk for blood clots, studies began to suggest that Yaz, a combination of ethinyl estradiol and drospirenone, put women at an even greater risk for the serious side effects. As a result, thousands of women and their loved ones have filed lawsuits against Bayer arguing they were not warned of the dangerous and life-threatening risks associated with Yaz.

SOURCE: Yaz Lawsuit › Yaz is most popular birth control pill among teenagers

About 7,000 lawsuits have been filed against Bayer by women or their family members who allege that they were not warned by Bayer that company’s birth control pills Yaz and Yasmin could put them at serious risk of life-threatening blood clots, heart attacks, strokes, and gallbladder damage. More plaintiffs are joining the lawsuit and some estimate that there could be as many as 14,000 plaintiffs in all.

While the documents are stored at a St. Louis-based law firm and are managed by one attorney with a full-time IT employee for technical support, firms across the country are helping review the documents and can access the database remotely. To date, about 150 attorneys have been trained how to use the data base, and up to 50 people review the documents as much as five days a week.

The paperwork not only includes documents related to Bayer’s Yaz and Yasmin, but also to generic versions of the drugs, including Ocella and Gianvi.

The first bellwether case trial is set for September. Aside from the federal litigation in southern Illinois, consolidated lawsuits are pending in Pennsylvania, California and New Jersey state courts.

SOURCE: Yaz Lawsuit › Bayer generates millions of pages for Yaz, Yasmin lawsuits

Yasmin is part of Bayer’s “four sisters” of oral contraceptives that include Yaz and Yasmin as well as the recently introduced folic acid-fortified pills Beyaz and Safyral. All four use a combination of the hormones ethinyl estradiol and drospirenone. The pills brought in more than $1.5 billion, a 13 percent drop from 2009.

Yaz was approved by the Food and Drug Administration (FDA) in 2006, and was marketed as a new kind of birth control pill that not only prevented pregnancy but also tackled PMS symptoms such as irritability and helped clear up acne. The marketing campaign launched Yaz into the best-seller category among birth control pills, with many women asking their doctors for it by name.

The FDA soon penalized Bayer for running ads that overstated the drug’s benefits and downplayed the serious risks, including the risk of blood clots, heart attack and strokes. The FDA also ordered the drug company to run a series of clarification ads.

Soon after, Bayer was hit with thousands of lawsuits from women who claim they suffered serious health problems from the pills and that Bayer knew the risks but did not adequately warn consumers.

The bad press surrounding Yaz and Yasmin have contributed to the drugs’ lagging sales over the past year, which may explain why the company is fighting generic competition that would devour more of its waning profits.

SOURCE: Yaz Lawsuit › UK blocks sales of generic Yasmin

The study, published in the journal Obstetrics & Gynecology, focused on lower-income California women who were given a year’s supply of the pill compared to women who only got enough packs for one or three months at a time. Researchers found that for every 1,000 women who participated in the study, 10 who had the year’s supply of pills got pregnant, compared to 30 of the women who were only given a one to three month’s supply.

The study also showed that about two out of 1,000 women given the long-term prescription for pills had a state-funded abortion in the following year, whereas six out of 1,000 women who were given a shorter-term prescription had state-funded abortions.

Despite the results, researchers say the study does not prove that longer lasting pill prescriptions will prevent unwanted pregnancies and abortions.

In California and most other states, Medicaid programs limit prescription drugs to a one-month supply. Nationwide, about 75 percent of women on birth control pills receive no more than a three-month supply of birth control pills.

Insurance companies may limit the length of oral contraceptives in part because of the serious side effects they may carry, such as the risk for blood clots. Some pills, such as the widely used Yaz, may put women at even greater risk for developing blood clots, which can lead to heart attacks, strokes, and even death.

SOURCE: Yaz Lawsuit › Year-long birth control prescriptions may lower unwanted pregnancy rate

Blood clots can occur after some surgeries, when people travel long distances, or sit in cramped positions for long periods of time. It can also be caused by medications, especially birth control pills. Some oral contraceptives may carry a greater risk for blood clots. For example, Bayer, maker of the popular birth control pill Yaz, is facing more than 2,000 lawsuits from women who say the pills caused them to suffer blood clots that in some cases led to serious complications such as pulmonary embolism, heart attack and stroke.

At least 100,000 cases of pulmonary embolism occur in the United States each year, and it is the third most common cause of death in hospitalized patients. If left untreated, about one-third of victims die, which is why the National Heart Lung and Blood Institute urges the public to know the symptoms of pulmonary embolism. The most common ones include shortness of breath when not exerting yourself, chest pain and coughing up blood.

Often, the only symptoms are those associated with DVT, such as swelling of the leg or along the vein of the leg, pain or tenderness in the leg, a feeling of increased warmth in the area of the leg that is swollen and tender, and red or discolored skin on the affected leg. Other symptoms include excessive sweating, clammy or bluish skin, light-headedness, fast or irregular heartbeat, and weak pulse.

These symptoms should be considered serious, and anyone who experiences these should seek medical attention immediately.

SOURCE: Yaz Lawsuit › Tennis star’s blood clot scare helps raise awareness

Most women who become pregnant are typically tested for gestational diabetes by their obstetricians. It is caused by high blood sugar (glucose) levels. Most women with gestational diabetes are able to control their blood sugar and avoid harm to themselves or their baby. Once the baby is delivered, the mother’s blood sugar usually goes back to normal. But these women are at risk for developing type 2 diabetes within five to 10 years of delivery. The new study suggests these women are at an even greater risk if they take the mini pill following pregnancy.

On a more positive note, another recent study found that women on mini-pills are at no greater risk for developing heart disease compared to women who were not taking oral contraceptives. The mini pills are also less likely to cause blood clots than the traditional estrogen-plus-progestin pills.

Some studies suggest that specific types of combination birth control pills, such as Yaz, which combines ethinyl estradiol and drospirenone, put women at an even greater risk for blood clots. To date, more than 2,000 lawsuits have been filed against Bayer, the makers of Yaz, from women who say they suffered heart attacks, strokes, blood clots and even gallbladder damage after taking Yaz.

SOURCE: Yaz Lawsuit › Mini pills may increase chances of developing type 2 diabetes

Generic drugs must still be approved by the FDA but the process is different than with brand-name medications. Emoquette was approved through the agency’s abbreviated new drug application process, which requires drug makers prove their drug is comparable to an approved medication in dosage, route of administration, quality, performance and intended use.

Drugs are not allowed to be marketed and sold in the United States without FDA approval. This process requires proof from clinical trials the medication is both safe and effective. But the FDA’s seal doesn’t guarantee there will be no problems.

In the early 2000s, the FDA approved Bayer’s Yaz birth control pills. The pills combined the hormones ethinyl estradiol and drospirenone, which also works as a diuretic. Bayer launched a massive marketing campaign that sent sales of Yaz skyrocketing.

It wasn’t long, however, before reports of blood clots, heart attacks, and strokes in young women taking Yaz began to surface. While oral contraceptives carry a risk for blood clots, the problem seemed to more often affect women taking Yaz. As lawsuits against Bayer began to mount, the pharmaceutical company responded by seeking – and obtaining – FDA approval for three more birth control pills with the same hormone combination as Yaz – Yasmin, Beyaz and Safyral.

SOURCE: Yaz Lawsuit › FDA approves generic birth control pill

The FDA does not regulate over-the-counter medications as it does prescription drugs, which raises safety concerns first and foremost. Birth control pills already carry risks that women should be aware of, including the formation of  blood clots. Women who smoke and those with a family history of blood clots are at an even greater risk for developing blood clots, which can lead to life threatening conditions such as heart attacks, strokes and pulmonary emboli.

There is also no word on which pills would be made available without prescription. Pills offer a variety of single or combination hormone options, and some even include diuretics or are fortified with vitamins. Some may put women at even greater risk for serious side effects, such as the blockbuster birth control Yaz, manufactured by Bayer. The company is currently facing more than 2,000 lawsuits from women who claim they were injured by Yaz.

The FDA says one of the biggest benefits to keeping oral contraception a prescribed product is that for many women getting a birth control prescription is the motivating factor in getting them to the doctor for their annual exam. If birth control pills suddenly became available over-the-counter, many woman may forego seeing their doctors altogether.

SOURCE: Yaz Lawsuit › DC considers making birth control pills available OTC

Two years later her doctor made a connection. Lana had been taking Yaz or Yasmin birth control pills for seven years, since 2001. The pills have been linked to gallbladder damage, yet Lana says she was never warned of those risks by the pills’ manufacturer, Bayer Corp. Lana is now one of more than 2,000 women who have filed lawsuits against Bayer. The plaintiffs claim that Bayer was fully aware of the risks associated with use of the pills, yet the company did nothing to warn users.

Yaz and Yasmin are known as fourth generation birth control pills. They contain the hormones ethinyl estradiol and drospirenone. Drospirenone also works as a diuretic, which can cause an increase in potassium levels in the blood and lead to hyperkalemia, which can cause heart rhythm abnormalities that can cause life threatening blood clots.

Lana is no longer taking the pills, but she still experiences problems and was diagnosed with post-cholecystectomy syndrome. The condition causes persistent pain I the upper right abdomen, nausea, vomiting, gas, bloating and diarrhea. Symptoms of the syndrome occur in about 5 to 40 percent of patients who undergo cholecystectomy.

Lana’s lawsuit seeks unspecified damages. The case has been assigned to Galveston County Court in Texas.

SOURCE: Yaz Lawsuit › Woman blames gallbladder problems on Yaz, Yasmin

Chairman Andreas Fibig told reporters at a press conference in Sao Paulo that the company’s strong market position in Brazil, paired with new products that will be introduced to the Latin American market in the months and years to come will help drive that anticipated growth. Bayer is planning to introduce at least five new drugs in Brazil this year, including birth control pills, hypertension treatment, and a drug to treat erectile dysfunction.

Bayer’s birth control pill Yaz took off with a bang in the United States. Fronted by a strong marketing campaign that touted the pills as a cure-all for everything from acne to irritability, the drug soon became the No. 1 selling oral contraceptive in America with many women asking their doctors for it by name. But it wasn’t long before the Food and Drug Administration (FDA) cracked down on Bayer, saying the pricey ad campaign overstated the drug’s benefits and downplayed its risks. Bayer was ordered to run new ads that clearly warned women that the pill could cause life threatening blood clots.

But it was too little, too late. By then, thousands of women had already been sickened or had died from blood clots, heart attacks, strokes, and even gallbladder damage. The bad press led to a severe drop in Yaz sales, taking a bite out of the company’s profits.

Bayer currently faces more than 2,000 lawsuits from women who say they were not adequately warned that Yaz could make them seriously ill.

SOURCE: Yaz Lawsuit › Bayer targets Brazil for future sales of birth control pills

The study, published in the Journal of Clinical Endocrinology and Metabolism, included data from more than 1,800 women between the ages of 16 and 44 on birth control pills and summarizes six previous studies related to heart attack risk in women taking the so-called mini-pills. Brand name mini-pills include Micronor and Ovrette.

More women take the combined estrogen-and-progestin pills than the mini-pills, and that is where researchers say the results become more skewed. The combined pills carry an increased risk for blood clots, which can lead to heart attacks, strokes, pulmonary embolism (blood clot in the lungs), and deep vein thrombosis, all of which can be life threatening.

Some studies suggest that some varieties of combined oral contraceptives put women at greater risk for blood clots, such as Yaz, a fourth-generation pill that includes the hormones ethinyl estradiol and drospirenone.

Women who are high risk for heart disease, such as women who smoke or have high blood pressure or a family history of blood clots, may consider switching to progestin-only products, or going off birth control pills altogether.

SOURCE: Yaz Lawsuit › Mini-pill may be safer than combination birth control pills

Perhaps Lucy was fooled by the aggressive advertising campaign launched in early the 2000s by Bayer Healthcare, the makers of Yaz. The ads touted the birth control pill’s strengths, such as fighting irritability from premenstrual syndrome and clearing up troublesome acne, and downplayed the serious side effects associated with the drug. Those side effects include blood clots, such as pulmonary embolism and deep vein thrombosis, as well as heart attack, stroke, and gallbladder damage. The deceptive advertising for Yaz paid off for Bayer. The pills became the top selling oral contraceptive in America.

But soon Bayer couldn’t escape the bad press that was growing from reports of these serious side effects happening in women and in some cases resulting in death. Bayer, instead, claimed the pills were no more dangerous than other birth control pills. Meanwhile, the Food and Drug Administration (FDA) ordered Bayer to run a new set of ads for Yaz clearly stating the harm the drugs may cause. The information came too late for Lucy.

“I am at home right now with very low energy and barely able to care for my children. Ladies, it is not worth it. My children were almost without a mother. I am unable to take anything without hormones now for the rest of my life, not to mention the painful treatments and the prescriptions I have to use now,” Lucy warned. “Please do not risk your life!”

* Not her real name

SOURCE: Yaz Lawsuit › Doctors blame woman’s blood clots on Yaz birth control

Yaz is considered a fourth-generation birth control pill and contains a combination of hormones known as ethinyl estradiol and drospirenone. Drospirenone also works as a diuretic.

Since Bayer Healthcare introduced Yaz to the market in the early 2000s, the company has launched three other birth control bills with similar formulations. The pills have become a favorite among young American and Canadian women, thanks to a massive marketing campaign claiming the pills help fight the symptoms of premenstrual syndrome and clear up acne.

The ads also effectively downplayed the serious side effects associated with the drug, which include blood clots, pulmonary embolism, deep vein thrombosis, heart attack, stroke and gallbladder damage. Soon after the commercials hit the airwaves, the Food and Drug Administration (FDA) ordered Bayer to rerun ads clearly stating the serious side effects that the drugs could cause.

Some experts question the use of drospirenone in the pills, claiming the diuretic can cause a condition that leads to irregular heart rhythms. Those arrhythmias can cause serious health problems, including blood clots, heart attacks and strokes.

The revision ads from Bayer came too late for thousands of women, including Amie and Lauren. Both women have joined the more than 2,000 other women who claim they were injured by Yaz and filed a lawsuit against Bayer.

SOURCE: Yaz Lawsuit › Deceptive ads lead to two more lawsuits against makers of Yaz

Carole Ann wasn’t the only woman swayed by the playful advertisements – Yaz soon became the best selling birth control pill in the nation. However, Carole Ann found out the hard way that women like her were being fooled by Bayer Healthcare, the makers of Yaz. She suffered a blood clot in her lungs, known as a pulmonary embolism.

Soon after the ads began, the Food and Drug Administration (FDA) slapped Bayer Healthcare with heavy fines and ordered the company to run a series of retraction ads that clearly stated the benefits of the pills as well as the risks involved.

“You may have seen some Yaz commercials recently that were not clear,” the revised ads say. “The FDA wants us to correct a few points in those ads.” Those corrections specify that the pills are not approved to tackle symptoms of PMS, but rather premenstrual dysphoric disorder, or PMDD, a condition with severe emotional and physical premenstrual symptoms. The ads also more clearly reported serious side effects, including blood clot conditions such as pulmonary embolism and deep vein thrombosis, heart attacks, stroke, and gallbladder damage.

The revision ads came too late for Carole Ann. She took the pills and suffered a life-threatening blood clot in her lungs. Carole Ann is one of thousands of women in the United States and Canada who has filed a lawsuit against Bayer Healthcare alleging that the pharmaceutical company did not adequately warn her of the dangers of taking the pill. She claims she would not have taken the pill had she known of the dangers. She is seeking compensatory and punitive damages including economic damages, economic damages and medical expenses, attorney’s fees, costs and other relief.

SOURCE: Yaz Lawsuit › NJ woman files lawsuit against makers of Yaz birth control

Oral contraceptives marketed today that contain ethinyl estradiol and drospirenone in varying doses as their major ingredients include Bayer HealthCare’s Yaz, Yasmin, Yasminelle, Beyaz and Safyral; Teva Pharamaceutical’s generic Gianvi; and the generic ocella. The fourth-generation pills have grown to become one of the most prescribed birth control pills in the country.

What makes these pills work differently is drospirenone. The compound is different from other synthetic progestins in that it appears to be closer to the natural progesterone. Because of this, drospirenone may lead to less water retention and breast tenderness and could help reduce acne. But it also means that the drug may cause an increase in potassium levels which can potentially cause hyperkalemia, a serious condition that may result in death. Thus, the pills are not recommended in patients with hepatic dysfunction, renal insufficiency, or adrenal insufficiency.

Drospirenone-containing pills also carry a risk for blood clots, and it is not recommended for use in patients who are smokers, or have a history of deep vein thrombosis, stroke or other blood clots.

Since the pills became available, more than 4,000 lawsuits have been filed against the makers of the pills alleging that the ethinyl estradiol/drospirenone formulation oral contraceptives put them at greater risk for serious injury and death.

SOURCE: Yaz Lawsuit › Ethinyl estradiol + drospirenone – a deadly combination?

“Sadly, she was a normal, healthy young woman before this,” she told the CBCNews Facebook community. “Now she will never be able to take birth control again and will forever be worried about blood clots and what the long term effects are from this drug.”

Several community members expressed concern over Yasmin, an oral contraceptive made by Bayer HealthCare that combines the hormones ethinyl estradiol and drospirenone. Bayer also makes Yaz, Beyaz and Safral with a similar combination of hormones. The pill is also known by the generic ocella. All have a similar side effect profile.

All oral contraceptives carry a risk for blood clots, but some say Bayer’s pills put women at even greater risk. CBC News recently covered a story saying Canadian doctors don’t think Yasmin is more dangerous than other pills, but that notion was squashed by numerous commenters to the CBC story. The sad truth is that thousands of women have experienced blood clots, heart attacks, strokes, and gallbladder damage.

More than 800 Canadian women and 4,000 American women have filed lawsuits against Bayer looking for compensation for their pain and suffering.

SOURCE: Yaz Lawsuit › Facebook community speaks out about dangers of Yasmin

Researchers collected data by studying a group of rhesus macaque monkeys at the OHSU Oregon National Primate Research Center for eight months. The specific breed of monkeys were used because their reproductive system is nearly identical to humans’. But unlike studies involving humans, the variables in the monkey studies could be controlled and measured, such as exact food consumed.

At the beginning of the study, half the monkeys were obese and half were of normal weight. During the treatment period, the monkeys received doses of oral contraceptives, which were adjusted according to the animals’ weight so that the effects would match those of humans. Weight, food intake, activity levels, body fat and lean muscle mass were all recorded. At the end of the study, the monkeys of normal weight maintained a stable weight, whereas the obese monkeys lost a significant amount of weight and body fat due to an increase in basal metabolic rate.

While the news is encouraging, women who choose to take birth control pills should heed warnings of serious side effects. All birth control pills carry a risk for blood clots, but some studies suggest pills that combine the hormones ethinyl estradiol and drospirenone can put users at even greater risk of blood clots. Brand-name pills with this formulation of hormones include Yaz, Yasmin, Bayaz, and Sayfral.

SOURCE: Yaz Lawsuit › Birth control pills do not cause weight gain, but can cause blood clots

All oral contraceptives carry a slight risk for blood clots, which can lead to heart attack, stroke, deep vein thrombosis or pulmonary embolism. But two separate European studies that suggest Yaz and Yasmin, made by Bayer HealthCare, put users at greater risk for blood clots than other birth control pills.

The “fourth generation” pills were the first to contain two hormones, ethinyl estradiol and drospirenone, the latter active ingredient also acts as a diuretic. The Food and Drug Administration has since approved two other birth control pills with the same combination of hormones plus folic acid. Those pills are marketed as Bayaz and Safyral.

In an effort to quell public panic, the Society of Obstetricians and Gynaecologists of Canada issued a statement saying Bayer’s pills posed no greater risk than other birth control pills. But some medical experts say the European studies shouldn’t be dismissed. One of the studies, published last year in the British Medical Journal, showed a six times greater risk of blood clots in women using Yasmin versus other types of birth control pills.

The group cited a third study of nearly 60,00 users of various birth control pills, which showed no real difference in risk among the pills; however, that study was sponsored by Bayer, makers of Yaz and Yasmin. Critics say Bayer’s vested interest in the outcome of the study could have influenced the results.

SOURCE: Yaz Lawsuit › Yaz, Yasmin lawsuits could cause public panic, unwanted pregnancies

Let’s take a closer look at these “four sisters” of Bayer oral contraceptives:

• Yaz is a combination birth control pill containing the hormones drospirenone (3 mg) and ethinyl estradiol (20 mcg). Drospirenone also works as a diuretic. It was the first birth control pill approved to treat premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms. It is also used to treat moderate acne.
• Yasmin is a similar formulation as Yaz but contains 3 mg drospirenone and 30 mcg of ethinyl estradiol. Yasmin is only approved for the prevention of pregnancy and not for treating the symptoms of PMDD nor the treatment of moderate acne.
• Beyaz was approved for sale in the United States in September 2010 and is essentially identical to Yaz but was the first birth control pill to include folic acid. Folic acid is the B vitamin that has been shown in pregnant women to reduce the occurrence of brain and spinal cord defects in their children if taken before and during the first three months of pregnancy. Like Yaz, Beyaz is approved for use as a form of birth control, for the treatment of PMDD symptoms, and for the treatment of moderate acne.
• Safyral is Bayer’s folate-added version of Yasmin. Formulated with the same types and doses of active ingredients as Yasmin, Safyral also adds folic acid as an added benefit.

All four Bayer birth control pills are surprisingly similar and, like Yaz, carry the same risk of serious health problems. While all oral contraceptives carry a risk of blood clots, heart attacks and strokes, some say Bayer’s pills put users at greater risk than other pills. An unusually large number of women who take Bayer’s pills have also reported gallbladder damage that in many cases has resulted in surgery to remove the gallbladder.

SOURCE: Yaz Lawsuit › Bayer’s ‘four sisters’ of birth control pills have same bad reputation

But the honeymoon would soon end for Bayer, as reports of potentially fatal side effects from Yaz and Yasmin began to surface. Bayer was also slapped by the Food and Drug Administration (FDA) with fines and ordered to spend millions on new ads to clarify its benefits (for example, the pills are approved for the treatment of premenstrual dysphoric disorder, PMDD, and not PMS) and clearly state the risk for side effects such as blood clots.

While Bayer contends that its pills are no more dangerous than other birth control pills, thousands of women have filed lawsuits against the company claiming the pills are far more dangerous than other pills and that Bayer failed to adequately warn them. Serious and life-threatening side effects associated with Yaz and Yasmin include blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolism, and gallbladder damage.

Despite the reports of serious problems, Yaz and Yasmin remain on the market and are still being used by hundreds and thousands of women. Warn your friends and family members of the dangers associated with Yaz and Yasmin by using social media tools such as Facebook and Twitter. Your friends and followers may appreciate the warning.

SOURCE: Yaz Lawsuit › Alert your friends to the dangers of Yaz, Yasmin

“SAFYRAL and Beyaz are part of Bayer’s growing women’s health franchise, and these new products reinforce our commitment to providing women with various contraceptive options,” said Leslie North, Vice President of Marketing, Women’s HealthCare, Bayer HealthCare Pharmaceuticals.

Bayer also offers the blockbuster birth control pills Yaz and Yasmin, both of which contain the diuretic drospirenone but no folic acid. The pills have come under fire in recent years because of mounting reports of serious side effects associated with the pills.

While all oral contraceptives put women at a slightly increased risk of developing blood clots, some studies show that the combination hormone with diuretic puts women at even greater risk. The pills also increase a woman’s risk of suffering from gallbladder problems that in many cases have resulted in surgery to remove the gallbladder.

Bayer faces thousands of lawsuits from women who have suffered serious health consequences – such as heart attacks, strokes, deep vein thrombosis, and gallbladder damage – while on Yaz and Yasmin. The company says that Beyaz and SAFYRAL have the same safety profile as Yaz and Yasmin.

SOURCE: Yaz Lawsuit › Bayer launches second birth control pill with folic acid

For the next three years, Katie took Yaz, but by the time she was ready to enter college, something changed. She felt constantly sick and spent much of her time in bed. “I didn’t go out. I didn’t see friends. I just laid in bed for the most part, and I was sick all the time,” she told KOKO News. “Eventually, I was vomiting bile.”

Doctors were baffled why such a healthy girl would turn so sick. They soon pinpointed the problem. Katie’s gallbladder was damaged. “I found out that my gallbladder function was at about 64 percent, and it should be between 98 and 100 percent,” she said. She was taken off Yaz and underwent surgery to remove her gallbladder.

Katie is one of thousands of women who are suing Bayer, makers of Yaz. They claim that the drug company was aware its top-selling pill was dangerous but failed to adequately warn women or their doctors of the risks. Bayer contends that Yaz carries the same risks as other oral contraceptives.

Just as the ads claimed, Yaz is different than other pills. It contains a diuretic that doctors say can raise potassium levels in the blood. This can cause the gallbladder to malfunction as well as cause blood clots that increase the risk of other serious problems such as heart attack and stroke.

As for those ads that sold women, like Katie, on the benefits of Yaz? Not long after they started running, the Food and Drug Administration (FDA) penalized Bayer, arguing that the ads for Yaz overstated the drug’s benefits and downplayed the risks. The company was ordered to run a series of ads clarifying its approved uses and clearly stating the risks, which include blood clots, heart attacks, strokes and gallbladder damage.

SOURCE: Yaz Lawsuit › Yaz likely cause of girl’s damaged gallbladder

Sarah’s take on the commercials is hysterical, but the ads alone are often comical with women kicking away signs of irritability and moodiness, and cartoon girls diving into pools. “We all know that birth control pills are 99.9 percent effective at preventing pregnancy. But did you know there is a pill that can do more?” says a woman on a Yaz commercial.

Click here to view the embedded video.

Unfortunately, Yaz did do a lot more. And it’s hardly a laughing matter. The one-time best selling birth control pill is linked to serious injuries and death in many young women, and the lawsuits against the pill’s maker, Bayer, are mounting into the thousands. Plaintiffs say Bayer was aware that Yaz could cause serious health problems such as blood clots, heart attacks, strokes and even gallbladder problems but the drug company failed to adequately warn women. Instead, the drug company ran playful commercials that overstated the drug’s benefits and downplayed its side effects.

The Food and Drug Administration (FDA) came down on Bayer for the misleading commercials and ordered the company to remake and rerun ads on Yaz. The new ads clarified the drug’s approved uses, which are not for mild PMS, but for the more severe PMDD, and specifically stated the pill’s risks, which includes blood clots, heart attacks and strokes.

Now generic versions of Yaz are hitting the market and Bayer is feverishly working to maintain its share of profits from the drug including launching Beyaz, a new version of Yaz that contains folic acid. Will the marketing materials for Beyaz admit they are just as “safe” as Yaz? Only time will tell.

SOURCE: Yaz Lawsuit › Parody of BCP commercials does not diminish safety concerns

But folic acid also offered other benefits, some experts claimed. Since folic acid lowers blood levels of the protein homocystine, which is linked to heart and blood vessel disease and other medical problems, some scientists suggested that the B vitamin could also lower the risk of heart disease, stroke or cancer.

However,  a new study published in the Oct. 11 issue of the Archives of Internal Medicine shows that even taken at high doses, folic acid supplements do not improve one’s risk of getting heart disease, a stroke or cancer.

To further complicate matters for Beyaz, the pill contains the same active ingredients as its sister product, Yaz – a hormone and a diuretic. Thus, Beyaz, like Yaz, is indicated not only for pregnancy prevention but also for the treatment of premenstrual dysphoric disorder (PMDD) and moderate acne. It also carries the same health risks, according to clinical studies conducted by Bayer.

Bayer contends that Yaz is no more harmful to women than other birth control pills, which carry a risk of life threatening blood clots. But more than 2,000 lawsuits by women who were seriously injured by Yaz beg to differ.

B vitamin-fortified or not, is Beyaz really a safe choice for women?

SOURCE: Yaz Lawsuit › New birth control pill contains folic acid, but is the B vitamin ‘all that’?

Yasmin and Yaz generate nearly $2 billion each year for Bayer, making the oral contraceptives the largest source of income for the drug company. The drugs contain a special formulation of hormones plus drospirenone, a diuretic, and were heavily marketed following FDA approval for not only preventing pregnancies but also relieving the severe emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) and treating moderate acne.

As sales for the birth control pills exploded in the United States, reports began surfacing of serious side effects associated with the drugs, including heart attacks, strokes, blood clots and even gallbladder problems. Lawsuits followed, alleging the drug company was aware the pills put women at greater risk of life threatening health problems but failed to adequately warn consumers. Bayer claims its pills are no more dangerous than other birth control pills. More than 2,000 lawsuits have been filed against Yaz and Yasmin.

Earlier this month, the FDA approved Watson’s oral contraceptive Zarah, a generic version of Yasmin. Bayer also launched a variation of Yaz, called Beyaz, from which the company expects to generate an annual income of about $680 million.

SOURCE: Yaz Lawsuit › Bayer continues to fight generic competition of its birth control pills

Levomefolate calcium is a folic acid, the B vitamin recommended for all women of childbearing age because low folate levels are associated with neural tube defects such as spina bifida. Like Yaz, Beyaz is indicated for the prevention of pregnancy but can also be used to treat the symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne. Beyaz’s added benefit is that it can help prevent neural tube defects in the offspring of women who conceive while using the pill or shortly after discontinuing it.

The launch of Beyaz comes at a critical time for Bayer, as the drug company faces more than 2,000 lawsuits from women who claim they were made sick by Yaz or Yasmin. The plaintiffs claim they suffered strokes, heart attacks, blood clots and even gallbladder problems after taking the pills but were not adequately warned by Bayer that taking the drugs could cause them serious health problems and even death. Bayer has held firm to its claim that Yaz is no more dangerous than other birth control pills.

An FDA press release said clinical trials with Beyaz showed the same overall safety profile as seen with Yaz.

SOURCE: Yaz Lawsuit › Bayer launches new birth control pill fortified with folic acid

There are more than 2,000 women across the country who would tell Beth to get off the pills immediately. The women, like Gina Miller, suffered serious health problems such as heart attacks, strokes, blood clots and gallbladder problems after taking Yasmin and its similar oral contraceptive, Yaz. They have now filed suit against Bayer, makers of Yasmin and Yaz, claiming they were not adequately warned that the birth control pills they were taking could cause life-threatening health problems and death.

Bayer has done little to reassure women, arguing its pills are no more dangerous than other birth control pills. Some studies, however, suggest that there is a higher incidence of adverse events with Yasmin and Yaz than other oral contraceptives. The pills, and their generic equivalents, are the only ones sold in the U.S. that contain drospirenone, a diuretic, that can cause an increase in potassium levels in the blood, which can lead to heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death, pulmonary embolism, DVT and other serious problems.

Doctors caution patients not to suddenly stop taking any medications, including birth control pills. However, the serious side effects associated with Yasmin would suggest women like Beth should definitely talk to their doctor as soon as possible about how to safely make a switch.

SOURCE: Yaz Lawsuit › ‘Should I still be on Yasmin?’

“My first symptoms were that my back was hurting,” Gina told WISH-TV. Her doctor diagnosed her with pneumonia. After treatment, she started running again, but she just couldn’t seem to get her stride back. “I was fatigued and short of breath,” she said. “I just didn’t feel like myself.”

Not long after that, Gina’s back pain came back and this time was so severe she was hospitalized. That’s when doctors discovered that Gina’s pain was caused by multiple pulmonary embolisms, or blood clots in her lungs.

How could such a young, healthy woman become so seriously ill? Doctors told Gina that her blood clots were likely caused by her birth control pills. Yaz, Gina soon discovered, had caused numerous women of all ages to suffer serious side effects from pulmonary embolism and deep vein thrombosis, to heart attack and stroke. Some women also reported gallbladder problems.

More than 2,000 women who became ill while taking Yaz and Bayer’s sister contraceptive, Yasmin, have filed suit against the drug maker claiming they were not adequately warned that taking Yaz or Yasmin could cause them serious illness and even sudden death.

Gina has filed a lawsuit against Bayer and is telling her story to warn other women of the dangers of Yaz and Yasmin. “I will be completely fine,” she said. “But for a lot of women, they weren’t so lucky.”

SOURCE: Yaz Lawsuit › CFO blames Yaz for her life-threatening blood clots

Watson Pharmaceuticals

Like Yasmin, Zarah is a combination of the diuretic drospirenone and the hormone ethinyl estradiol. While all birth control pills carry risks of blood clots and other serious injuries, some studies suggest that Yasmin and its sister contraceptive, Bayer’s Yaz, carry a greater risk than other pills. To date, more than 2,000 lawsuits have been filed against Bayer from women who claim they were harmed but not adequately warned by the drug company that by taking the pills they would be at greater risk of life threatening blood clots, strokes, heart attacks and even gallbladder problems.

The lawsuits don’t seem to sway drug makers from moving forward with generic versions of Yaz and Yasmin. Watson, too, is facing a lawsuit from Bayer, which claims  Zarah infringes on Bayer’s patent for Yasmin. The case is currently pending in the U.S. District Court for the Southern District of New York. Despite the lawsuit, Watson has begun shipping Zarah for distribution.

SOURCE: Yaz Lawsuit › Watson receives FDA approval for Zarah, generic version of Yasmin

It’s the same question thousands of woman are asking after suffering serious health problems they say were caused by Yaz and Yasmine birth control pills. The pills are a unique formulation that combine a new hormone called ethinyl estradiol with the diuretic drospirenone. Bayer Healthcare, the company that produces the pills, claimed the formulation not only prevented unwanted pregnancies, but also helped curb symptoms of premenstrual dysphoric disorder (PMDD) and moderate acne.

However, experts say the diuretic causes an increase in potassium levels that can lead to blood clots, which puts women at an increased risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis, and even death. More than 2,000 women have filed suit against Bayer claiming they were not adequately warned that taking Yaz or Yasmin put them at risk for serious and life threatening health problems.

“There are a bunch of people out there (who have fallen ill after taking Yaz),” Mollie writes. “Let’s hope we can find them and make other girls aware just how dangerous Yaz really is.”

SOURCE: Yaz Lawsuit › Yaz blood clot victim hopes to warn others

Instead of instant death, these blood clots slowly filled Jones’ lungs for an entire month before she started experiencing symptoms – difficulty breathing and pain in her side. Doctors said it was caused by her birth control pills and aggravated by a genetic blood disorder called factor V Leiden. “Factor V is hereditary and can be passed down from one or both parents,” she said. She first learned she had the condition while lying in the hospital bed fighting for her life.

All birth control pills carry a risk for blood clots, but some people argue that the one-time best-seller pills Yaz and Yasmin carry an even greater risk of serious side effects including pulmonary embolism, deep vein thrombosis, heart attack, stroke and even gallbladder problems. To date, more than 2,000 lawsuits have been filed against the makers of Yaz and Yasmin from women who say they were not adequately warned that by taking the pills their lives could be in danger.

“I’ve been given different reports from my doctors, but the truth is that there is a risk for getting blood clots from birth control pills,” Jones writes. “Those warning statements and fine lines after TV commercials are there for a reason. Blood clots can cause heart attacks, strokes, pulmonary embolisms, kidney problems and even death. I don’t have anything against birth control, but before going on it, be aware and recognize the possible side effects.”

SOURCE: Yaz Lawsuit › Woman blames birth control pills for nearly killing her

“Hormone intake in the form or oral contraceptives has the potential to positively influence bladder and urethral function,” Dr. Daniel Altman from Karolinska Institutet in Stockholm told Reuters Health. The study involved 8,689 twins who were studied by researchers via the Internet, and was featured in the August issue of Fertility and Sterility.

Researchers looked for bladder disorders in their study subjects such as stress incontinence, urgency incontinence, and overactive bladder. They found that among women of child-bearing age, current use of oral contraceptives was associated with a 43 percent lower risk of stress urinary incontinence, a 48 percent lower risk of mixed urinary incontinence, and a 64 percent lower risk of urgency urinary incontinence. However, the study showed conflicting evidence on the effects of hormone intake on lower urinary tract symptoms in women who were past menopause.

Despite the findings, the Women’s Health Initiative does not support the use of hormone replacement therapy or oral contraceptives to treat lower urinary tract problems. Both can cause serious problems for older women. For example, hormone replacement therapy, generally prescribed to treat menopause symptoms, has been linked to an increased risk of breast cancer. And birth control pills put women at greater risk for life-threatening blood clots, strokes, and heart attacks.

SOURCE: Yaz Lawsuit › Study: The Pill can reduce risk of urinary tract problems

Novartis isn’t the only drug company to delve into web advertising. Last year, FDA’s Division of Drug Marketing, Advertising and Communications sent notices to 14 major pharmaceutical manufacturers informing them that their sponsored link advertisements violated disclosure agreements and did not adequately warn consumers of the drugs’ risks. This prompted Google to produce “FDA Friendly” banner ads, which were used by Bayer to market its blockbuster birth control pill Yaz. The ads’ headlines link to the product’s site, but the text encourages viewers to read the product information including the boxed warning.

Bayer is required to be extra cautious with its advertising of Yaz. The company launched its birth control pill with an advertising campaign that the FDA later said was misleading. The agency accused the company of overstating the drug’s benefits and using busy images to clutter its message on drug risks. Bayer was fined and ordered to run new ads that clearly stated the drug’s risks, which include blood clots, heart attacks, strokes, and gallbladder problems.

SOURCE: Yaz Lawsuit › FDA cracks down on drug companies’ use of web marketing

Planned Parenthood is offering to help women decide what type of contraception is best suited to them. My Method is an online questionnaire developed because “birth control methods are not one-size-fits-all.” Take the survey here.

The brief questionnaire is written for women. Men are welcome to take the survey but they should answer the questions from their partners’ perspectives. The questions are simple and ask about your lifestyle, and likes and dislikes. There are no right or wrong answers.

One of the most popular forms of contraceptives is birth control pills. They are up to 99 percent effective at preventing pregnancy, but they also carry serious risks. Planned Parenthood advises women who have had breast cancer or who think they may be pregnant not to take birth control pills. They are also contraindicated in women with blood-clotting problems; those who suffer from migraine headaches with aura; have blood clots or vein inflammation; have had heart attack, stroke or angina; or have serious diabetes.

But one pill has been singled out by Planned Parenthood, Yaz, also known as Yasmin, the country’s best-selling oral contraceptive. The warning says, “You should not take the birth control pill Yasmin or Yaz if you have ever had kidney, liver, or adrenal gland disease. Yasmin and Yaz contain a special progestin that may increase potassium levels and cause serious heart and other problems.”

To date, more than 2,000 lawsuits have been filed against the makers of Yasmin and Yaz by women who say there were seriously harmed by the pills.

SOURCE: Yaz Lawsuit › Survey helps women choose the best birth control method for them

Bayer cleverly launched Yaz in 2006, promising that the new formulation birth control pill – a combination of ethinyl estradiol and drospirenone – not only prevented pregnancy but also helped treat premenstrual symptoms and acne. Women began to ask their doctors for the pill by name, skyrocketing sales. Soon after, a review by the Food and Drug Administration (FDA) found the ads for Yaz to be misleading. The agency accused Bayer of over-stating the drug’s benefits and covering up its risks, and ordered the company to run correction ads. But the new formulation of active ingredients offered by Yaz had already hit superstar status among women.

Gradually, however, reports of women suffering sometimes fatal blood clots and other serious health problems began to surface. Bayer is now facing more than 2,000 lawsuits from women who allege they were not adequately warned that Yaz could cause them serious harm.

Rising out of the flurry of lawsuits, Bayer seems determined not to lose ground in all the bad press from Yaz. It is launching Natazia. This pill contains a new type of estrogen that has never been used before in an oral contraceptive. It hits the market with a Black Box Warning on its safety label, informing that women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal genital bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant) or liver disease, or who are pregnant, not to take Natazia. For women who don’t fall under any of the risk categories, is Natazia worth trying?

National Public Radio this week responded to the news of Natazia this way: “It’s a good time to look at the Yaz saga and see if it has anything to teach women and their doctors when they choose a contraceptive.” Indeed. The moral of this story: Beware of the latest and greatest drugs unless there’s some reason that the ones that have been around for a while don’t work for you.

SOURCE: Yaz Lawsuit › Bayer launches new birth control pill amid a flurry of Yaz lawsuits

Birth control pills increase a woman’s risk of life-threatening blood clots, a condition obese women are already at greater risk for than normal-weight women. Birth control pills with higher estrogen levels put women at even greater risk for developing blood clots, which can lead to deep vein thrombosis, pulmonary embolism, heart attack, stroke and even death. Thus, prescribing high-dose birth control pills to obese women can be dangerous.

The clinical trial involved 226 normal-weight or obese women who were randomly assigned to take pills with either a lower or higher estrogen dosage. All women underwent blood tests to determine if they were using the pills consistently. After three or four cycles, the women received multiple ultrasounds and blood tests to determine if their ovaries were making eggs. About 90 percent of normal-weight women and 72 percent of obese women had hormone levels that indicated consistent use.

Of the remaining 150 women who used the oral contraceptives regularly, three out of the 96 normal weight women conceived compared to one out of the 54 obese women, leading researchers to determine that obese women were just as protected against unwanted pregnancies while on the pill as normal-weight women.

This fall, the National Institutes of Health will convene a group of experts to investigate whether further research is necessary on obesity and oral contraceptives. Meanwhile, the Food and Drug Administration plans to hear evidence that a new emergency contraceptive pill is less effective in obese women.

SOURCE: Yaz Lawsuit › Study: Birth control pills just as effective for obese women

Despite a court order for the pharmaceutical company to hand over some 10 million pages of documents related to the oral contraceptive and the marketing for it, Bayer is playing hardball. The company is reportedly delivering the documents out of order or without attachments as it issues statements to the media that Yaz and Yasmin are no more dangerous than other birth control pills.

Yet, if that were the case, why did Bayer promote its oral contraceptives with flashy ads that, the Food and Drug Administration (FDA) says, overstated the benefits of the pills and downplayed the risks? The federal agency fined Bayer and ordered the drug company to launch a second campaign that more clearly stated the approved uses for the pills and the risks associated with them.

It seems every week there is another news story about a woman who has died or suffered severe health consequences associated with use of Yaz and Yasmin. That, coupled with the arrival of generic competition from drug maker Teva, has resulted in a 15 percent drop of Yaz sales. One can only wonder how much the legal settlements with Yaz/Yasmin victims will cost Bayer.

SOURCE: Yaz Lawsuit › Lawsuits against Yaz, Yasmin double to 2,000

The fight between Bayer and Teva over their rival oral contraceptive pills continues to heat up. In June, Bayer argued that Teva made claims on Givani’s safety label that were false, claiming that its pill contained the same technology as Yaz that enabled it to have a longer shelf life. Teva agreed to change its labeling to include the adjusted shelf life claims and to inform pharmacies in the United States of this change on a weekly basis for three months.

The patent infringement suit Bayer has filed against Teva asks for an injunction to prevent Teva from selling Gianvi. Teva was awarded a 180-day marketing exclusivity period for Gianvi by the Food and Drug Administration (FDA) after being the first company to file an Abbreviated New Drug Application (ANDA). Bayer claims Teva stepped on its toes by prematurely launching Gianvi.

Perhaps a bigger bite to Bayer’s profits will come when it begins to settle the more than 1,100 lawsuits filed against it from women who claim the drug company didn’t adequately warn them that they were at greater risk of developing serious health problems such as blood clots, heart attack, stroke and gallbladder problems.

SOURCE: Yaz Lawsuit › Yaz generics, lawsuits take bite out of Bayer’s profits

Acne spurred by hormone changes usually occurs the week before the period and often springs up on the chin. “In that situation, you might prescribe a birth control pill along with their standard regimen,” Dr. Berson told Modern Medicine. Oral contraceptives shouldn’t be looked at as the lone cure-all for acne. “It is something that is given to prevent further breakouts. … You would still give it along with the traditional therapies, whether they are topical or oral.”

But birth control pills are not without risks. “Most of the side effects are due to the estrogen component,” Dr. Berson says, adding that the most common problems associated with the pill include nausea, headaches and breast swelling. But, she adds, “there is still potential for deep vein thrombosis and vascular events.”

Yaz (as well as Yasmin and the generic ocella) is one type of birth control pill that has been singled out for its indication for treating acne as well as taming the symptoms of premenstrual dysphoric disorder (PMDD). Because it has multiple indications, more prescriptions are written for Yaz in the United States than any other birth control pill. But, there have also been more lawsuits filed against Yaz from women who say they suffered serious health problems from the pill, including blood clots, heart attacks, strokes, deep vein thrombosis, pulmonary embolism and even gallbladder problems.

Women who have a history of blood clotting disorders, migraines, high blood pressure, smoking or heart disease should not take oral contraceptives because they are at greater risk for blood clots. But even women who had no prior health problems that would make them a bad candidate for the birth control pills still became ill after taking Yaz.

“You want to make sure that (women) understand the potential risks, such as blood clots,” Dr. Berson says.

SOURCE: Yaz Lawsuit › Should you use the pill to treat acne?

Sure, the pharmaceutical company sells the top selling birth control pills in the nation – Yaz and Yasmin. The pills have earned the company a reported $1.5 billion in 2009 alone. Both Yaz and Yasmin contain drospirenone, a diuretic, which no other brand of oral contraceptive has. This special formulation, Bayer says, makes the pills an effective treatment for premenstrual dysphoric disorder (PMDD) and moderate acne. The company launched an advertising campaign for Yaz in 2007 and 2008 that resulted in skyrocketing sales.

It wasn’t long before the Food and Drug Administration (FDA) found those ads to be misleading. The agency accused Bayer of exaggerating the pills’ benefits and camouflaging the risks behind busy graphics. In February 2009, Bayer agreed to spend $20 million to run a series of corrective ads. They also agreed to submit future ads for the pills to the FDA for approval. But the damage had already been done. Thousands of women began suffering from blood clots, heart attacks and strokes, and soon after began filing lawsuits against Bayer saying they were not adequately warned of the risks.

Now, Bayer wants to assure us that they are a trusted source for women with questions about their contraception. I think I’ll leave the medical advice to my physician instead.

SOURCE: Yaz Lawsuit › Should you really trust Bayer for contraception advice?

“I used to take Yaz until it mess up my gallbladder and I had to get surgery to have it removed. Thank you, Yaz!”

“I have heard bad things about this brand of contraception so I will not use it.”

“Don’t take Yaz. *personal experience*”

Yaz, also known as Yasmin and by the generic ocella, was introduced in the United States as a new type of birth control pill that not only prevented unwanted pregnancies but also helped curb the symptoms of premenstrual dysphoric disorder (PMDD) and treat moderate acne.

The pills were marketed by a massive adverting campaign, but the Food and Drug Administration (FDA) slapped Bayer, the makers of Yaz and Yasmin, with a huge penalty saying its ads didn’t adequately warn women of the risks associated with the pills, such as blood clots that could lead to pulmonary embolism, heart attacks and strokes, as well as gallbladder problems. The drug company was forced to run more ads clearly stating its approved uses and possible risks.

When Bayer began running the disclaimer ads, the pills were already the top selling oral contraceptives in the country, bringing in billions of dollars annually to Bayer. Meanwhile, thousands of otherwise healthy women were beginning to fall ill and even die from blood clots and other health problems. Bayer now faces more than 1,000 lawsuits from women injured by the pills.

Is it any wonder Yaz has a bad reputation on YouTube?

SOURCE: Yaz Lawsuit › Bad press catches up with top selling Yaz, Yasmin

“Our goal is to evaluate objectively the risks and benefits of demedicalizing contraceptive care, with an eye toward improving access to OCs (oral contraceptives) and potentially other hormonal contraceptive methods by making them available without a prescription,” a statement from the nonprofit advocacy group reads.

The group says there is substantial literature available on oral contraceptives that show birth control pills meet most of the Food and Drug Administration’s criteria for OTC status. “The drug’s benefits outweigh the risk for women of reproductive age; the potential for misuse or abuse is low; a consumer can easily self-diagnose the condition for which the pills are indicated; and directions for use are straightforward.”

Birth control pills have a host of minor side effects including vision changes, breast tenderness, fluid retention, weight gain, acne, headaches, depression and anxiety. But women who use estrogen-containing birth control pills are at a 3- to 6-fold increased risk of developing blood clots. Blood clots may lead to deep vein thrombosis, heart attack or stroke.

Some studies suggest that different types of birth control pills can put women at an even greater risk of blood clots. Most notably is Bayer HealthCare’s blockbuster birth control pill Yaz, also known as Yasmin and by the generic ocella. Yaz is the top-selling birth control pill in the country, yet few women realize they are at risk of blood clots until it is too late. To date, more than 1,100 lawsuits have been filed against Bayer by women who allege they were not adequately warned by the drug company that taking Yaz put them at greater risk of serious injury.

Making oral contraceptives available OTC does have benefits. It will give women greater control over their birth control choices, and that could lead to easier access to higher rates of initiation, continuation and fewer gaps in use, thereby “potentially leading to an overall decrease in rates of unintended pregnancy and abortion,” the organization’s statement reads.

For now, the Working Group on Oral Contraceptives Over-the-Counter will carry out several activities, including research, engaging in public education and discussion, and building consensus on key issues. “We will initiate dialogue with professional medical organizations, host a meeting to gauge support for this issue among organizations representing diverse groups of women, and create informational materials on the safety of OCs.”

SOURCE: Yaz Lawsuit › Group advocates to make birth control pills available OTC

High blood pressure is known as the silent killer because most often there are no symptoms. The symptoms that do occur include chest pain, confusion, ear noise or buzzing, irregular heartbeat, nosebleed, tiredness, and vision changes. Complications from high blood pressure include aortic dissection, blood vessel damage, brain damage, congestive heart failure, kidney damage, kidney failure, heart attack, hypertensive heart disease, stroke and vision loss.

There are many different medications that are used to treat high blood pressure. You can lower your risk by making lifestyle changes, including exercising, losing weight and following a healthier diet. You may also be advised to stop taking other medications, such as birth control pills.

Oral contraceptives can increase blood pressure and carry a slight risk of blood clots that can lead to heart attacks and strokes as well as other life-threatening problems. Recent studies suggest that some pills are more dangerous than others, such as the country’s most popular birth control pill, Yaz, also known as Yasmin and by the generic ocella. Bayer, the maker of Yaz and Yasmin, currently faces more than 1,100 lawsuits from women who say the pills caused them to suffer from blood clots, heart attacks, strokes, gallbladder damage and other serious health problems.

SOURCE: Yaz Lawsuit › Women with high blood pressure should use caution with ‘the pill’

“Bayer is committed to vigorously enforcing its intellectual property and continues to pursue its patent infringement case filed earlier against Teva in Nevada,” Bayer said in a statement. The suit filed in Nevada asks for an injunction to prevent Teva from selling Gianvi. Teva was awarded a 180-day marketing exclusivity period for Gianvi by the Food and Drug Administration (FDA) after being the first company to file an Abbreviated New Drug Application (ANDA). Bayer says Teva is prematurely launching its new drug.

Bayer says it dropped its suit in Delaware because Nevada was a more appropriate venue. Concentrating its efforts in Nevada “will eliminate the risk of inconsistent adjudications,” Bayer said in a statement.

The fight between Bayer and Teva over their rival birth control pills has become heated over the past few weeks. Last month Bayer argued that Teva made claims on Gianvi’s safety label that were false. Gianvi’s label claimed that the pill contained the same technology as Yaz that would extend its shelf life. Teva has agreed to inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label. The information has already been sent to the FDA for review and added to Teva’s website.

Bayer’s legal woes concerning Yaz are expected to continue for some time. The company faces more than 1,100 lawsuits from women who claim the popular birth control pill caused them to suffer from serious injuries such as blood clots, strokes, gallbladder problems, and even death.

SOURCE: Yaz Lawsuit › Bayer drops lawsuit against Teva over Yaz/Gianvi, but the fight continues

“Defendants have been issued warnings by the FDA at least three times – in 2003, 2008 and 2009 – for misleading the public through the use of ads which overstate the efficacy of YAZ/Yasmin and minimize serious risks associated with the drug,” the lawsuit reads.

Heather was prescribed and took Yaz/Yasmin beginning in October 2008 through July 2009 and during that time suffered multiple pulmonary emboli. She believes her birth control pill put her at greater risk for developing the serious side effects and blames Bayer for ignoring the link between the use of the pills and the increased risk of serious and life threatening side effects. Heather’s is one of more than a thousand lawsuits filed against Bayer for inadequately warning women of the risks of blood clots, strokes, heart attacks, gallbladder problems and other serious health issues, including death.

Heather’s lawsuit was filed against Bayer Corporation as well as Bayer Healthcare, Bayer Pharmaceuticals, Berlex, Berlex Laboratories, Bayer Schering Pharma AG, and Bayer Healthcare AG under the Louisiana Products Liability Act. She is seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings, loss of earning capacity, interest, and court costs.

SOURCE: Yaz Lawsuit › Another woman files lawsuit against makers of Yaz

Herndon was appointed to preside over numerous lawsuits from across the country from women who claim they were seriously injured by the unique birth control pills. The women say the drugs’ safety labels did not adequately warn them of an increased risk of health problems such as blood clots, strokes, heart attacks, gallbladder damage and sudden death.

Bayer’s Yasmin and Yaz, and the generic versions Ocella and Gianvi, are marketed not only for their contraceptive but also as a treatment for premenstrual dysphoric disorder (PMDD) and for the treatment of moderate acne. The pills are also the only ones sold in the U.S. that contain drospirenone, a diuretic, which can cause an increase of potassium levels in the blood. This imbalance can lead to heart rhythm disturbances that can trigger blood clots and other serious injuries.

Source: Madison/St. Clair Record

SOURCE: Yaz Lawsuit › Judge orders birth control pill makers to turn over files for litigation

Now, Bayer has waged another fight against the rival drug company. Bayer filed suit against Teva claiming some information on Gianvi’s label was false. The drug’s safety label claimed the birth control pill contained the same technology as Yaz that extended its shelf life. According to Bayer, Teva will inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label. Teva has already updated the information on its U.S. website and provided the Food and Drug Administration with the corrected information.

Yaz contains drospirenone and ethinyl estradiol that is enclosed within a beta-cyclodextrin (betadex) clathrate. A clathrate is a molecule that forms a “cage” around another molecule or molecules. The betadex clathrate in Yaz is a Bayer-patented technology that protects the enclosed ethinyl estradiol molecule and stabilizes the product against oxidation. This patented technology enhances the product’s shelf life.

Bayer also faces more than a thousand lawsuits from women who claim they have suffered serious injuries such as blood clots, strokes and gallbladder damage from Yaz but the drug’s safety label did not adequately warn them about the risks.

Yaz has earned Bayer more than $1.5 billion since 2009.

SOURCE: Yaz Lawsuit › Bayer, Teva rival birth control pills go head-to-head in court

Brenda’s story is told far too often these days. She is one of more than 1,100 women suing the drug company alleging claims of serious health problems after taking Yasmin, also known as Yaz. The lawsuits claim Bayer was aware of the increased risk of life-threatening blood clots in women taking Yasmin but they failed to adequately warn consumers of that risk. Some studies have backed up those claims; however, Bayer contends the blood clot risk for Yasmin and Yaz is no greater than other oral contraceptives.

Bayer has a reason to contest the claims made by the defendants. Its popular birth control pills have brought in $1.5 billion since 2009, making Yaz and Yasmin the most popular birth control pills in America and a favorite in Canada and numerous European countries. Yasmin and Yaz are different from other birth control pills because they contain drospirenone, a diuretic, that can increase potassium levels in the blood. This imbalance can trigger heart rhythm disturbances that can cause blood clots that can lead to pulmonary embolism, strokes, or even sudden cardiac death. The pills have also been linked to gallbladder disease.

Source: WPIX

SOURCE: Yaz Lawsuit › ‘Wicked’ understudy suffers stroke, joins lawsuit against Yasmin

The women’s claims are backed up by a recent study published in the British Medical Journal that found women on Yaz and Yasmin had double the risk of blood clots and strokes compared to other brands of birth control pills. Yaz and Yasmin are the only oral contraceptives that contain a diuretic known as drospirenone. The study attributed the increased risk of blood clots to the diuretic.

“It appears as though there is a higher risk with Yasmin compared to the others,” Dr. Ravi Patel told KGET 17 News. “But it doesn’t mean the others don’t have a risk. The others may have a four-fold risk, this may have a six-fold risk compared to a normal individual of getting blood clots if they are not taking birth control or hormonal replacements of any kind.”

KGET 17 News contacted Bayer for comment but the company did not return the call. Bayer has said previously that Yaz and Yasmin carry the same risk of blood clots and strokes as other brands of birth control pills.

SOURCE: Yaz Lawsuit › More women join lawsuit against Yaz, Yasmin makers

Bayer has reason to want to protect its territory. Yaz, also known as Yasmin, brought in $782 million in sales in 2009, making it the top oral contraceptive in the nation. However, with popularity comes criticism. Bayer faces more than 1,100 lawsuits from women who allege that Yaz caused them to suffer serious health problems including heart attack, stroke, pulmonary embolism, blood clots, kidney failure, deep vein thrombosis, and gallbladder disease. Some fatalities have also been reported.

Yaz is marketed as an innovative new type of birth control pill containing drospirenone and ethinyl estradiol that not only serves as an effective contraceptive but also a proven treatment for premenstrual dysphoric disorder (PMDD) and severe acne. Drospirenone is a diuretic that can increase potassium levels in the blood and cause heart rhythm disturbances that can lead to blood clots and other serious problems.

The pills’ safety labels include a risk of potentially life threatening events, but women say Bayer downplayed those side effects even though it knew Yaz was just as, if not more, dangerous than other oral contraceptives. It is expected Gianvi will carry the same risks as its brand-name competitor.

Source: Globes

SOURCE: Yaz Lawsuit › Bayer sues Teva for prematurely marketing generic Yaz

Kathy Perea

Kathy says the attacks began shortly after she started taking the Yasmin birth control pill. “I would wake up in the middle of the night and it would feel like someone had hit me with a baseball bat in my rib,” she said. So she stopped taking the pill. Her symptoms did not go away. That’s when her doctor told her the damage had already been done. Her gallbladder was damaged and had to be removed.

Yasmin, also known by the brand name Yaz and the generic Ocella, is one of the top selling birth control pills in the country. It is the only one that combines a hormone with a diuretic. While Bayer HealthCare, the maker of Yasmin, says the pill carries the same risks as other birth control pills, women like Kathy say they believe Yasmin is more dangerous and that they were not adequately warned by the drug company of the serious side effects that could occur with taking the once-daily pill.

To date, Bayer faces more than 1,100 lawsuits from women who allege they were harmed by the drugs. Many claim to have suffered damage to their gallbladder. Others claim the pills caused them to develop life-threatening blood clots and other serious medical conditions.

Though Kathy is feeling better she says she still suffers from occasional pain after eating. She blames Yasmin for threatening her life, and she wants justice. “I have five kids I have to support financially and I had to miss days of work. I had to have surgery,” Kathy said through tears. “That’s money coming out of my pocket for something they didn’t tell me was going to happen to me.”

SOURCE: Yaz Lawsuit › Woman blames Yasmin for damaging her gallbladder

Dawn Varrechio

Like many women, Dawn was taking Yaz birth control pills, the most popular oral contraceptive in America. What she didn’t realize is that by taking Yaz she was putting herself at greater risk for life-threatening blood clots. Last year, two studies published in the British Medical Journal found women on Yaz to be at greater risk of developing blood clots than on other forms of birth control. Bayer HealthCare, makers of Yaz, sponsored two previous studies that discount those claims, arguing that Yaz doesn’t increase blood clot risk any more than other brands of birth control pills.

Yaz, also known by the brand name Yasmin and the generic Ocella, is the only birth control pill that contains drospirenone, a diuretic, and ethinyl estradiol. The pills were touted not only for pregnancy prevention but also for the treatment of severe acne and premenstrual dysphoric disorder, or PMDD. Yaz soared in popularity, becoming a blockbuster money maker for Bayer.

But as Bayer began collecting its profits, reports of serious injuries and deaths in women who took the drug began pouring in. Bayer now faces more than a thousand lawsuits from women who say Yaz caused them to suffer from health problems such as heart attacks, strokes, pulmonary embolisms, blood clots, deep vein thrombosis, and gallbladder disease.

Survivors can only hope their problems don’t return. “It’s scary,” said Dawn, who says she now worries about the long-term effects Yaz will have on her. “It’s really scary.”

SOURCE: Yaz Lawsuit › Woman worries about long-term effects of Yaz

Irina Shiryaeva

Blood clots are one of the most common causes of death in the United States, second only to cancer. Despite their prevalence, only six percent of Americans know the symptoms and risk factors of blood clots – including pulmonary embolism and deep vein thrombosis, or blood clots that commonly affect the leg veins.

According to the National Alliance for Thrombosis and Thrombophilia, there are many known causes for blood clots to form. Those factors include prolonged bed rest or inactivity, such as long plane rides. The lack of movement can cause reduced circulation in the legs. Most surgical procedures or physical trauma can also increase one’s risk. Other situations that increase one’s risk of blood clots includes pregnancy, oral contraceptives and hormone replacement therapy.

Estrogen does not cause blood clots, but it does dramatically increase a woman’s risk. Most birth control pills, which include an estrogen and progestin, increase a woman’s risk of blood clots by as much as three- to four-fold. About one woman out of 300 taking oral contraceptives will develop a blood clot. Women on birth control pills who have additional risk factors – such as taking a long-distance trip or flight – are at even greater risk of developing potentially life threatening blood clots.

While manufacturers of birth control pills and even birth control patches have warnings on their label of the increased risk of blood clots, many women who have been harmed by them say the warnings weren’t adequate enough. Several lawsuits have been filed against the makers of Yaz, Yasmin and its generic, Ocella; and Johnson & Johnson, maker of the Ortho Evra birth control patch, has paid millions to settle lawsuits from women who have suffered blood clots after using the patches.

Unfortunately, it’s too late for Irina, who leaves behind a husband and 3-year-old son.

Source: News Observer

SOURCE: Yaz Lawsuit › Birth control pills, long plane flights increase risk of blood clots

“I’d been popping a drug every morning for years knowing only what my doctor had said: the Pill ‘regulated’ my periods. I had always backed it up with condoms. I had taken it through my teens when I wasn’t having sex. It was an unthinking habit. It took one last switch to another brand, an eye-opening two-month break, then six months back on the Pill to make me realize what it had been doing to my body and my mind throughout my adult life. I came to understand why I felt so very sick,” she writes in a recent column recognizing the Pill’s 50th anniversary.

Over the course of a decade, the writer took four different birth control pills, including Yasmin, a pill also marketed as Yaz in the United States and the UK. Made by Bayer HealthCare, the oral contraceptive has become one of the most widely used birth control pills in the world.

“I was taking the brand Yasmin, which I had requested from my doctor after reading in magazines about its amazing skin-clearing and weight-loss side effects. My sisters and many of my friends were also taking it. Yasmin was marketed aggressively in the US, and news of its supposed benefits spread quickly to young women in the UK. The New York Times recently described Yasmin as the ‘go-to drug brand for women,’ which has been sold as a ‘quality-of-life’ treatment,” Grigg-Spall wrote.

Last year, the Food and Drug Administration (FDA) penalized Bayer for overstating the benefits and covering up the risks of Yaz and Yasmin and ordered Bayer to produce commercials that clarified the uses and risks of the drugs. Bayer now faces more than 1,000 lawsuits from women who say they were harmed by the drugs but were not adequately warned of the risks involved. That information was enough to convince Grigg-Spall to look for other alternatives in contraception.

“The Pill is handed out to women with acne, PMS, irregular periods, heavy periods. The Pill has developed into a medication for the disease of being female. In place of changing society, society decided to fix women. On the 50th anniversary of the Pill we should stop celebrating the fictionalized revolution of the Sixties and turn our attention to the rebellion underway today. Young women are ditching the Pill in droves. They have come to see that the Pill can be harmful, as is the sugar coating used to make us swallow.”

SOURCE: Yaz Lawsuit › Columnist: 50th anniversary of The Pill nothing to celebrate

“I hate the pill. Hormonal contraception, which covers birth control pills and nearly every other highly effective method on the market, murders my libido. I say that with as much certainty as I can, given the murky, multi-variate thing that is the human sex drive,” she writes in a post titled Why I hate the pill. “I’ve experimented with several pills, hoping that any slight variation in hormonal ingredients would yield a contraceptive that worked without neutering me. Each doused my interest in sex as completely as the other. Although a libido-destroying pill does wonders to lower your pregnancy risk, it’s also done a number on my relationships, self-esteem and emotional well-being.”

Sealey says she didn’t find relief from her problem when switching to other forms of birth control. Nothing seemed to be the right “fit.” But she makes a good point. “If you’re like me, you assume that someone, somewhere is figuring all of this out — that there will be a new kind birth control discovered or invented at some point because that’s just how human progress rolls on. I mean, they’re already working on another iPad. Surely, some lab rat is putting the finishing touches on the next breakthrough in contraception.”

Unfortunately, Sealey says, any prospect for the development of innovative birth control methods have stopped dead in their tracks. “According to a 2008 report by Harper and several colleagues, public and private funds for contraceptive research have dried up in recent years. Most pharmaceutical companies have withdrawn from investing in contraceptive R&D, perhaps due to fears of costly personal injury litigation. And those fears aren’t necessarily unfounded. A reported 1,100 lawsuits have been filed in the United States against Bayer HealthCare alone, mostly by women claiming health problems such as blood clots, strokes, heart attacks and gall bladder disease after taking the popular pills Yaz and Yasmin.”

Perhaps the key is not finding new methods, but making the ones currently marketed to women safer to use.

SOURCE: Yaz Lawsuit › Women deserve safer options in birth control

The biggest disappointment on Bayer’s books was a 10.2 percent decrease in profits from sales of its blockbuster oral contraceptive, Yaz, also known as Yasmin and Yasminelle. Sales of the birth control pill, which combines drospirenone and ethinyl estradiol, have suffered in the U.S., according to Bayer, because “the discussion surrounding the thrombosis risk of contraceptives containing drospirenone.” Bayer says that it continues to believe that the risk profile is comparable to that of other combinations and “Yaz and Yasmin remain good choices for contraception when used as directed.”

Bayer is facing hundreds of lawsuits in the U.S. and beyond, claiming the company didn’t adequately warn consumers of an increased risk of serious health problems including stroke, heart attack, gallbladder problems and blood clots associated with Yaz.

As a result of the company’s weak pharmaceutical line, Bayer has lowered its sales guidance for the health care unit for 2010 to 3 percent from 5 percent. According to Bayer chairman Werner Wenning, “we are optimistic about the future and intend to build on the positive developments prior to 2009.”

SOURCE: Yaz Lawsuit › Bayer’s drug sales suffer due to bad press on Yaz blood clot risk

The news story focused on lawsuits filed against Bayer Healthcare over its birth control pills Yaz and Yasmin (ocella) and claims that the pill caused women, including young and otherwise healthy women, to suffer from serious and sometimes fatal blood clots.

“The studies don’t give a clear answer if Yaz and Yasmin are ‘the cause of health problems, including deep vein thrombosis (blood clots in the deep veins), strokes, heart attacks and gallbladder disease’ as they’re being accused of doing,” Garcia writes.

But Hull countered with a personal story. “It (Yaz) should scare the heck out of women! My wife began taking Yaz shortly after it hit the market in 2006, and a little over a year later she suffered a bilateral pulmonary embolism that devastated her. It caused a cascade of injuries that culminated in pulmonary arrest, multiple cardiac arrests, multiple strokes and ultimately an anoxic brain injury. At 46 years old she went from being vibrant and active to lying flat on her back and being unable to do anything for herself,” he responded. “Not worth it.”

SOURCE: Yaz Lawsuit › Husband of Yaz victim says pills were ‘catastrophic in our lives’

Yaz, and Bayer’s equivalent Yasmin, as well as the generic Ocella, are considered fourth-generation birth control pills. They contain a new type of synthetic progestin, drospirenone, that acts as a diuretic. The pills are promoted to not only prevent pregnancies but to also treat severe acne and premenstrual dysphoric disorder, or PMDD.

As of November, the Food and Drug Administration had received 993 reports of pulmonary embolism (blood clots in the lungs), 487 reports of deep vein thrombosis (blood clots in the deep veins), and 229 reports of other blood clots from birth control pills containing drospirenone.

Bayer stands by the safety of its blockbuster birth control pill, saying the pills carry the same health risk as any other type of oral contraceptive. However, two separate studies in the British Medical Journal claimed women were at as much as 6.3 times higher risk of developing blood clots when taking Yaz, Yasmin or Ocella. Recently, Bayer updated the labels of Yaz and Yasmin to include a risk of developing life-threatening blood clots.

SOURCE: Yaz Lawsuit › Yaz, Yasmin can be dangerous to your health

Research on the safety of the active ingredients in Yaz and Yasmin has offered mixed results. Some studies found drospirenone to be no more dangerous than other birth control pills, while other tests put the risk of getting blood clots – even in young, healthy women – as high as six times greater.

“There is reason to be concerned, I believe, about both of them [Yaz and Yasmin],” Dr. Sidney Wolfe, founder and director of Public Citizen’s Health Research Group, a nonprofit advocacy organization based in Washington, D.C., told the Los Angeles Times. “When evidence like that comes up, people should pay attention to it.”

Bayer Healthcare response? To keep mum. In statements to the press, Bayer still stands by its oral contraceptives saying they are no more dangerous than other birth control pills.

SOURCE: Yaz Lawsuit › Bayer Healthcare still stands behind safety of Yaz, Yasmin

The first birth control pills approved for use in the 1960s contained high amounts of hormones, resulting in bothersome and sometimes dangerous side effects including mood swings, weight gain and blood clots. Since then, hormone levels in pills have dropped to as low as one-tenth of what they were 50 years ago. The side effects waned and benefits, such as regulated periods, less acne and bloating, and lighter flows, began to win over skeptics. Long term studies identified even greater benefits – a lower risk of ovarian and endometrial cancers.

But what also began to surface most recently were lawsuits aimed at the manufacturers of birth control products. For example, Johnson & Johnson recently settled thousands of lawsuits from women who suffered blood clots and strokes from the company’s Ortho Evra birth control patch. Similar lawsuits are mounting against Bayer Pharmaceuticals’ blockbuster oral contraceptive, Yaz. And most recently, lawsuits have been filed against the makers of the NuvaRing birth control device, all from women who say they were not adequately warned of their risk of serious and life-threatening injury.

“There are terrible misperceptions about these methods— and about all forms of contraception,” James Trussell, director of the Office of Population Research at Princeton University, told the Wall Street Journal. Given the women who have suffered needlessly, perhaps those misconceptions are with merit.

SOURCE: Yaz Lawsuit › Birth control pills celebrate 50th birthday, but safety still in question

Bayer HealthCare

Yaz and Yasmin, as well as the generic Ocella, contain drospirenone, a diuretic that the plaintiffs claim elevated potassium in their bloodstream, which put them at greater risk for serious and sometimes fatal complications from blood clots, such as heart attack, pulmonary embolism, deep vein thrombosis and stroke. Diuretics can also cause significant problems with the gallbladder and may lead to gallbladder removal.

The lawsuits allege Bayer’s birth control pills put users at greater risk for serious adverse events; however, the company maintains that a woman’s risk of developing blood clots while taking Yaz or Yasmin is similar to other oral contraceptives.

Yaz and Yasmin were Bayer’s top-selling pharmaceutical last year, ringing in sales of $1.64 billion.

SOURCE: Yaz Lawsuit › Bayer adds new information about blood clot risk to Yaz, Yasmin labels

Bayer has an obvious vested interest in the outcome of that survey. The drug company makes one of the nation’s most popular oral contraceptives, Yaz. It is also known by the brand name Yasmin and the generic brand Ocella. Bayer has hit snags over the years marketing its blockbuster birth control pill.

First, the Food and Drug Administration (FDA) fined the drug maker and ordered they spend millions on a revamped advertising campaign after the agency deemed its Yaz commercials were misleading and were not being forthright about the drug’s life-threatening side effects.

Next came the lawsuits – an estimated 1,100 to date – from women who say they were not adequately warned of the dangers in taking Yaz. These women suffered from serious health problems including blood clots, heart attacks, kidney failure, gallbladder disease and seizures. Some complications resulted in death or disability.

Bayer’s response to the mounting lawsuits has been unwavering. The company contends it will “defend itself vigorously against these lawsuits.”

Source: Daily Record

SOURCE: Yaz Lawsuit › Bayer has vested interest in survey results