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

Thousands of women have joined the lawsuit against Yaz, alleging that Yaz caused serious side effects including gallbladder damage and blood clots. Blood clots are serious health problems that can lead to heart attacks, strokes, pulmonary embolism, and even death.

Yaz, and other newer generation oral contraceptives that contain the hormone drospirenone such as Bayer’s Yasmin and generic varieties, were the subject of an FDA review last month based on new studies that suggested the pills put users at greater risk for blood clots than birth control pills made with other hormones. The committee fell short of recommending the drug’s withdrawal, opting instead to put stronger warnings on the pills’ packages.

Bayer’s attorneys have challenged Kessler’s expert witness credentials before in this MDL, and plan to do so again before the case goes to court.

There should be plenty of time for both sides to work on their cases. Earlier this month, U.S. District Judge David Herndon postponed the Yaz MDL’s bellwether trial. It was to have begun this month but was pushed back to April 20, 2012.

Source: Reuters

SOURCE: Yaz Lawsuit › Yaz lawyers oppose former FDA chief’s testimony

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

What he has yet to accomplish is the removal of the birth control pill Yaz. The newer generation oral contraceptive contains the hormone drospirenone, and recent studies show the pill may put women at even greater risk for developing deadly blood clots than pills with older hormones.

Blood clots can be deadly and can lead to serious complications such as heart attack, stroke and pulmonary embolism.

An FDA advisory panel recently reviewed the blood clot risk with drospirenone-containing pills and fell short of recommending the drug’s removal from the market. Instead, the panel supported placing stronger warnings on the pills’ packages. It was a tremendous disservice to the public, Wolfe asserts.

Bayer, maker of Yaz and its sister contraceptive Yasmin, launched advertising campaigns when the pills hit the market that made the birth control pills the top-selling brands in the country. The company has made billions on the sales of the pills. Yet, when questioned about mounting reports of serious injuries associated with the pills, Bayer continues to insist Yaz and Yasmin are no more dangerous than other birth control pills.

Bayer currently faces thousands of lawsuits from women who say they were not adequately warned by the drug company that the pills could make them seriously ill.

When the FDA panel voted last month whether to keep Yaz on the market, Wolfe had already waged a war against Yaz. In his “Worst Pills, Best Pills” newsletter, Yaz was listed as a “Do Not Use” drug. Instead of allowing Wolfe to stand up against the birth control pills, the committee pulled his right to vote, citing an “intellectual conflict of interest.”

Source: Salem-News

SOURCE: Yaz Lawsuit › FDA advisor warns ‘do not use’ Yaz, Yasmin

U.S. District Judge David Herndon ordered Bayer and lawyers for the defendant to meet with mediator Stephen Saltzburg, a Gerorge Washington University law professor, to explore a possible settlement.

Yaz and Yasmin are a newer generation of birth control pills that contain the hormone drospirenone. New studies have indicated that the pills may put women at greater risk for suffering blood clots than pills with older hormones. An advisory committee to the Food and Drug Administration (FDA) last month recommended that stronger warnings about the greater risk of blood clots be added to the drugs’ safety labels.

Blood clots are potentially life-threatening conditions. They can break free and travel through the bloodstream and lodge in the heart and cause heart attacks, in the brain and trigger a stroke, or in the lungs which can cause a pulmonary embolism. Thousands of women allege that Bayer did not adequately warn them that taking Yaz or Yasmin could be deadly.

Yaz and Yasmin became the top selling birth control pill in the United States, with $1.58 billion in sales in 2010 alone. Bayer issued a statement saying that while it continues to defend the litigation, the company is engaged in mediation and settlement discussion.

Source: Business Week

SOURCE: Yaz Lawsuit › First Yaz lawsuit ordered to mediation for potential settlement

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

By taking a vow of celibacy, nuns deny themselves pregnancy and lactation, which means they have more menstrual cycles. Statistically, women who have more periods tend to be at greater risk for breast, ovarian and uterine cancers.

Comparatively, women who have babies beginning at a young age, have several babies, and who breastfed are less likely to develop these cancers.

Further, the overall mortality rate among women who use birth control pills is 12 percent lower than those who have never been on oral contraception. Their risk of developing ovarian or endometrial cancers is also reduced by 50 to 60 percent.

While birth control pills may help prevent nuns from getting cancer, it could put them at risk for other deadly conditions, such as blood clots. All pills carry a slight risk for blood clots, but some, such as the top selling Yaz and Yasmin, put women at even greater risk for developing blood clots, which can lead to heart attacks, strokes, pulmonary embolisms, and even death.

Thus, researchers say, the risks for recommending oral contraceptives to nuns – or any woman – for the prevention of cancer should be weighed against the potential risks of developing other serious health conditions.

Source: Fox News

SOURCE: Yaz Lawsuit › Pros and cons of birth control pills for nuns

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

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 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

By all accounts, Tania, who was studying to be a teacher, was the picture of health. She is now a statistic – a piece of data culled from research studies into the safety of birth control pills, like Yasmin, that contain the hormone drospirenone.

Yasmin is one of a family of birth control pills sold by Bayer. Other oral contraceptives that contain drospirenone include Yaz, Beyaz, and Safyral. The family of pills was Bayer’s top selling drug in 2010.

All birth control pills carry a slight risk for blood clots, but a new study suggests that pills that contain drospirenone may put women at even greater risk. The news has led the Food and Drug Administration (FDA) and Health Canada to undergo a safety review on the pills.

The study is based on about 300,000 women in the United Kingdom. Researchers found that women who were taking pills containing drospirenone were at about three times greater risk of developing blood clots in the lungs or legs than women taking oral contraceptives with an older hormone. Blood clots can cause heart attacks, strokes, and sudden death.

Bayer refuses to admit that its pills are more dangerous than others. The drug company also says its safety labeling includes a warning for blood clots. Genevieve finds this warning inadequate. “In the packet for Yasmin there’s a little booklet and it has 35 pages and on page 19 it lists the major side effects. I don’t believe Tania read it and I certainly didn’t. Because the pill is so widely accepted, you just don’t think that something might happen.”

Source: ABC

SOURCE: Yaz Lawsuit › Yasmin birth control pills claim another young life

The girl was prescribed Yasmin, manufactured by Bayer,  when she was 13 by her dermatologist to help clear up her acne. Her prescription was later changed to the generic Ocella, also manufactured by Bayer but marketed by Teva Pharmaceuticals. Yasmin and Ocella are part of a family of birth control pills that contain the hormone drospirenone. Other brands include Yaz, Yasminella, and Beyaz. Only Yaz and its generic equivalent Gianvi are FDA-approved for the treatment of acne in girls 14 and older.

The lawsuit alleges that Bayer heavily marketed the drugs to appeal to young women by highlighting its pills as a treatment for acne, and by downplaying the serious risks associated with the drugs.

All birth control pills carry a slight risk for blood clots, but recent studies suggest the risk with drospirenone-containing pills is even greater. Blood clots can cause strokes, heart attacks and sudden death. Pills containing drospirenone have also been linked to gallbladder damage.

Bayer faces about 7,000 lawsuits filed on behalf of women who allege they were not adequately warned that taking the pills could seriously injure or kill them.

SOURCE: Yaz Lawsuit › Family of deceased 15-year-old girl files Yasmin lawsuit

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

Birth control pills with the hormone drospirenone include Bayer’s Yaz, Yasmin, Beyaz and Safyral, as well as generics Ocella, Gianvi, Loryna, Syeda, and Zarah. The FDA says it hopes to have data later this summer from an 800,000-person study it commissioned to examine the risks.

While all birth control pills carry a risk for blood clots, the new studies indicate what many have feared over the years – that pills containing drospirenone were more dangerous. Not only had they become the most prescribed birth control pills in the country with more than 1.47 billion in sales, more and more reports of serious injuries and deaths were being reported in women who used the pills. Blood clots are serious health consequences that can lead to strokes, heart attacks, and sudden death.

Bayer has long defended its family of drospirenone-containing birth control pills, arguing that they are no more dangerous than other pills. Thousands of lawsuits have already been filed against Bayer by women or their family members who say they were not adequately warned of the risks.

The FDA says it will wait on more data to decide if more action should be taken. Until then, women who are using Yaz or other drospirenone-containing pills to seek immediate medical attention if they experience symptoms of blood clots, such as persistent leg pain, severe chest pain, or sudden shortness of breath.

Sources:
FDA
New York Times

SOURCE: Yaz Lawsuit › FDA keeping a watchful eye on studies on dangers of Yaz

“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

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

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

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

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

The study is the first to provide a comprehensive review of diagnosing, imaging and treating CVT. Researchers found that CVT disproportionately affects pregnant women or women taking birth control pills, as well as people 45 years of age and younger. Oral contraceptives put women at an even greater risk, and researchers recommend that patients with suspected CVT undergo blood tests to determine if they have an inherited or acquired factor in the blood that predisposes them to blood clots.

The safety labels of all birth control pills warn users of a risk for blood clots. However, studies suggest that some birth control pills put users at an even greater risk. Yaz and Yasmin are a type of “fourth generation” birth control pill that combines the hormones ethinyl estradiol and drospirenone. Propelled by pricy marketing campaigns, the pills quickly became the most popular type of oral contraceptive in the country, with many women asking their doctors for the pills by name.

Since the pills were introduced, the Food and Drug Administration (FDA) has received hundreds of reports of women who have been seriously injured while using Yaz and Yasmin. Problems include blood clots, heart attacks, strokes and even gallbladder damage. Bayer HealthCare, makers of Yaz and Yasmin, now face thousands of lawsuits from women claiming they were not adequately warned that using the pills could put their lives in danger.

SOURCE: Yaz Lawsuit › Birth control pills can cause rare form of stroke

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

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?

Yaz was marketed heavily across the globe, making it one of the best selling birth control pills and earning it more than $600 in sales in 2008. It is a combination of the hormones drospirenone and ethinyl estradiol. Drospirenone also works as a diuretic. Yaz is also touted as a treatment for acne and PMDD.

Bayer also sells Yasmin, a birth control pill with the same combined hormones but in different doses.

In 2010, Bayer also launched two other oral contraceptives with the same formulation but with added folic acid, known by the brand names Beyaz and Safyral. All four pills are considered to have the same side effects.

Despite the mounting lawsuits, Bayer stands by its defense that Yaz and its sister pills are no more dangerous than other birth control pills. The women who have filed lawsuits against Bayer say that the notion that Yaz is safe is simply a hard pill to swallow.

SOURCE: Yaz Lawsuit › Blood clots a serious side effect of Yaz birth control pills

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

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

The day before she died she was treated for a knee injury, but the injury wouldn’t have caused her death, her mother, Joan Cummins, told Lehigh Valley Life. “There’s just really no reason that a healthy young woman who had a knee injury would have developed this.” Cummins has another theory as to what caused her daughter’s death – her birth control pills. “She was on Yaz … for acne,” she said. “All you have to do is Google that and look at all the lawsuits.”

Now Cummins has joined thousands of other people affected by Yaz and filed a lawsuit of her own against Bayer Healthcare, the makers of Yaz. Cummins alleges that Bayer knew Yaz was more dangerous than other oral contraceptives and put women at greater risk for life-threatening blood clots but failed to adequately warn consumers. Bayer maintains that Yaz is no more dangerous than other birth control pills.

Last April, however, Bayer agreed to update the safety labels on Yaz and the birth control pill Yasmin to warn of “the relative risk of developing venous thrombosis.” Cummins said the warning is too little, too late. “(Michelle) was 18 years old, completely healthy, at college with the world at her fingertips,” she said. “Any medication we take, we’re so used to seeing may cause … all these side effects. You just think, ‘That won’t happen. My daughter will be fine…’”

SOURCE: Yaz Lawsuit › Mother sues Yaz maker for daughter’s untimely death

“My IQ plummeted to 77, borderline mentally retarded,” she told KOCO News. She gradually improved but even now she suffers from chronic pain, has no short-term memory, and cannot drive. She is one of thousands of women across the country who are suing Bayer, the makers of the best-selling birth control pill Yaz, for not properly warning her that taking the pill could cause her serious problems and even death.

If you saw the commercials for Yaz when the pill was first approved for sale in the United States, you would have thought it was designed to solve a host of problems from moodiness and irritability associated with premenstrual syndrome to unsightly acne. The ads worked. In no time Yaz became the best selling oral contraceptive in the United States.

The Food and Drug Administration (FDA) was one of the first to see through the façade. The pill was approved for the treatment of premenstrual dysphoric disorder, also known as PMDD, a far more severe condition than PMS. The ads also used vivid imagery to distract viewers while the drug’s side effects were read. The FDA ordered Bayer to rerun a series of ads, this time clearly stating what the drugs were approved for and clarifying associated risks.

Despite the ads, Bayer contends that its pills are just as safe as other birth control pills. Yet, Yaz is different from most in that it contains a diuretic, which can cause an imbalance in the body that can lead to blood clots, strokes, heart attacks and even gallbladder problems. As the lawsuits continue to mount against Bayer, it is likely the end is nowhere in sight. Some legal experts expect as many as 20,000 to 30,000 complaints from women who have been harmed by Yaz.

SOURCE: Yaz Lawsuit › Lawsuits continue to mount against makers of Yaz

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

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

Bayer faces more than 3,000 lawsuits claiming the company’s blockbuster birth control pills caused serious side effects, including strokes, heart attacks, gallbladder problems and even death.

In August, Bayer filed a protective injunction to keep plaintiffs from looking into the company’s marketing strategies for Natazia, a new birth control pill by Bayer that combines the same diuretic as in Yaz and Yasmin, drospirenone, with a different hormone, ethinyl estradiol. Plaintiffs’ attorneys fired back with a motion to include the redaction rules and remove the protective order for Natazia. Herndon changed the redaction rule, finding that the information about other drugs could lead to discovery of admissible evidence.

“From the exhibits counsel demonstrated in open court, it was clear that the redaction complained of made the production virtually useless in too many instances,” Herndon wrote. A status conference is planned for Oct. 12.

SOURCE: Yaz Lawsuit › Ruling prevents Bayer from editing documents in Yaz lawsuits

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

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

“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

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

What doctors discovered on Rose’s arm was a 10-inch blood clot that stretched from the base of her upper arm to her chest. They say it was caused by Rose’s birth control pills. Large clots like Rose’s that form in the veins of the arms or legs are often caused by a condition known as deep vein thrombosis. If left untreated, the clots could break off and travel to the lungs, which can be fatal.

The standard treatment for blood clots is drugs known as blood thinners. However, there is no guarantee the clot will go away and there is always a risk of internal bleeding. In search of a more effective treatment, Portola Valley physician Dr. Thomas Fogarty invented the Trellis Peripheral Infusion System, designed to remove large clots in veins using balloons and blood thinners that are injected into the clot area.

Fogarty’s Trellis device was approved by the Food and Drug Administration (FDA) in 2005, and has since been used on patients at more than 600 hospitals nationwide. The process involves navigating a catheter through the vein and into the clot and then inflating a balloon on either side of the clot. Trapped between the balloons, the blood clot is then injected with a clot-dissolving drug. The clot usually breaks up within an hour and patients are usually able to go home within a day with little more than a centimeter-sized scar.

Rose turned out to be an ideal candidate for the procedure, and she said she is pleased the process went so smoothly. “My Trellis scar is one dot,” she said.

SOURCE: Yaz Lawsuit › Trellis device offers safer and more effective treatment for blood clots

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?

“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

“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

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

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

But instead of seeking medical attention, Sara limped around in pain for three days as her leg began to swell from the knee down. “I should have listened to my gut and asked my father to take me to the doctor right then,” she said. “However, I felt silly about my worry because of my Achilles tendonitis and my young age.”

When her condition continued to worsen, Sara finally visited a doctor. The diagnosis surprised her. She had blood clot in her leg and needed immediate medical attention.

Blood clots can be deadly. What Sara learned is that despite her young age, she had common risk factors of blood clots – traveling in an airplane where she sat sedentary for hours, and using birth control pills. Oral contraceptives can increase the risk of blood clots due to the effect or dose of hormones, either estrogen or progestin. While the packaging on birth control pills may outline this risk, many lawsuits have been filed against makers of birth control pills by women who claim they were not adequately warned about the dangers in using the pills. To date, Bayer HealthCare faces more than 1,100 lawsuits for its oral contraceptives Yaz and Yasmin.

As part of her treatment, Sara had to discontinue use of her birth control. “I can never take birth control pills again and was told that if I get pregnant I will have to take a ‘blood thinner’ because changes during pregnancy make the blood clot more easily,” she said, adding a warning to other young women like her. “If you are contemplating use of birth control pills, make sure to discuss your family history (especially related to blood clots) as well as the adverse effects of birth control with your doctor.

“Take your life into your own hands.”

SOURCE: Yaz Lawsuit › Young woman warns others about birth control pills and blood clot risk

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

Like Natazia, Yaz and Yasmin were considered a new type of birth control pill. Yaz was approved by the FDA in 2006; Yasmin was approved in 2001. Both pills combine ethinyl estradiol and drospirenone, a diuretic not found in any other birth control product. The pills are marketed for the added benefit of treating severe acne and premenstrual dysphoric disorder, or PMDD. Both Yaz and Yasmin soared to the top spot on Bayer’s pharmaceutical sales list, bringing it more than $600 million in 2008 alone. It seemed almost too good to be true.

Then came the reports of serious injuries in women who took Yaz and Yasmin. The diuretic was believed to raise the potassium in women’s blood to dangerous levels, causing blood clots to form. Serious adverse event reports began pouring in, including heart attack, cardiac arrhythmias, stroke, pulmonary embolism, kidney failure, seizures, deep vein thrombosis (DVT), gallbladder disease, hepatic adenomas and even sudden death. The company now faces hundreds of lawsuits from women who say they were not adequately warned by Bayer of the serious health risks with using Yaz or Yasmin.

Prior to approval, two studies were conducted on the effectiveness of Natazia with a sample of 1,867 women. The most common side effects reported were irregular bleeding, headaches, nausea and vomiting.

SOURCE: Yaz Lawsuit › Yaz, Yasmin makers get approval for new birth control pill

“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

Despina Papparis

The Papparises are among 800 Canadians taking part in a $15 million class-action lawsuit against Bayer Healthcare, the manufacturer of the popular Yaz and Yasmin birth control pills claiming Bayer did not adequately warn women that taking the pills would put them at greater risk of serious health problems. According to the lawsuit, seven Canadian women and more than 50 American women have died while taking Yaz, Yasmin, or its generic Ocella.

Yaz, Yasmin and Ocella have been touted for benefits beyond just birth control. The pill has been marketed as an effective treatment for moderate acne as well as premenstrual dysphoric disorder (PMDD), a condition of severe emotional and physical premenstrual symptoms. The pills are formulated differently from other birth control pills because they contain drospirenone, a diuretic that can increase the potassium level in blood. This increase in potassium can cause heart rhythm disturbances that can cause blood clots as well as problems with the gallbladder.

Source: Calgary Herald

SOURCE: Yaz Lawsuit › 800 Canadians taking part in lawsuit against Yasmin, Yaz maker

According to the Southeastern Texas Record, three east Texas women filed lawsuits against Merck & Co. Inc., alleging that they relied on misrepresentations of the device and as a result suffered injuries. All claim the manufacturers failed to warn them of the greater risk of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

The Nuvaring controversy is just another incident in which women claim that makers of contraceptives failed to adequately warn them of the increased risk of serious injury when using the birth control. Johnson & Johnson recently paid $68 million to settle thousands of cases against women who say they suffered from blood clots and other serious events after using the Ortho Evra birth control patch. As a result, the company no longer actively markets the patch.

Bayer Healthcare has found itself in a similar mess with its biggest money-maker, Yaz, a birth control pill also known by the brand name Yasmin. Plaintiffs claim the hormone-plus-diuretic formulation is more dangerous than other oral contraceptives, causing life-threatening blood clots and gallbladder problems.

SOURCE: Yaz Lawsuit › Lawsuits claim Nuvaring is just as dangerous as Ortho Evra patch, Yaz

Monica Dakin

The 23-year-old Canadian was prescribed the popular oral contraceptive Yaz last May to treat her ovarian cysts. She believed the low-dose hormone carried fewer side effects than other birth control pills. But soon after starting the medication, she was doubled over with abdominal pain. Dakin was hospitalized six times in the first six months before surgeons finally removed her gallbladder in an emergency procedure.

Yaz, also known by the brand name as Yasmin and the generic version Ocella, was touted by its maker Bayer Healthcare for treating premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), and acne. This new type of contraceptive contains an added ingredient, a diuretic known as drospirenone. Dakin contends the diuretic caused the significant problems with her gallbladder and that she was never warned by Bayer that taking the pill could make her sick.

Dakin is one of hundreds of Canadian women suing Bayer Healthcare claiming they suffered severe adverse effects because of the popular birth control pill. The list of injuries includes everything from gallbladder problems to blood clots and even deaths. The lawsuits claim Yaz is more dangerous than other oral contraceptives and that Bayer knew this but failed to adequately warn consumers.

Dakin told Canadian news site HERE that the medical problems caused by Yaz have “ruined a year of my life.” Due to graduate from college in just a few months, she says she will have to sit out the ceremony because her illness set her too far behind.

SOURCE: Yaz Lawsuit › Canadian woman blames Yaz for year-long illness

Schwoob was one of two million Canadian women in 2009 prescribed Bayer Pharmaceutical’s blockbuster oral contraceptive Yasmin, according to TheSpec.com. Yasmin is also sold under the brand name Yaz and the generic brand ocella. Three months after starting on the meds, Schwoob suffered the chest pains. She says she was never warned that by taking Yasmin, she was at greater risk of suffering blood clots and other serious health problems. She is now a vocal representative of a class action lawsuit against Bayer filed by women, like her, who have been harmed by Yasmin. Bayer also faces hundreds of similar lawsuits in the United States.

Schwoob’s lawsuit claims Yasmin and Yaz carry a four times greater risk of deep vein thrombosis and pulmonary embolism compared to other contraceptives, yet the company failed to adequately warn the public of those risks. Bayer contests that notion, arguing that its birth control pills are safe and effective.

The class action lawsuit seeks damages of $500,000 for every woman who was prescribed Yasmin, as well as $20 million in punitive damages.

SOURCE: Yaz Lawsuit › Canadian women sue makers of Yasmin over health problems

Thanos is one of hundreds of women who have filed suit against Bayer, the makers of Yasmin, also known as Yaz and by the generic brand ocella. As the advertisements for the oral contraceptive say, Yasmin is a different type of birth control pill. The medication combines ethinyl estradiol with the diuretic drospirenone. The diuretic is considered the culprit, raising potassium levels in users’ blood, which can cause blood clots that can result in sudden cardiac death or pulmonary embolism or strokes. Diuretics also can cause significant problems with the gallbladder, leading to gallbladder removal.

But the advertisements for Yasmin focused on overstating the drug’s benefits as a treatment for premenstrual syndrome and acne control, and understating the serious risks associated with use of the drug. As a result, the FDA penalized Bayer, ordering it to spend $20 million on ads to clarify its use and the risks associated. The hundreds of plaintiffs in lawsuits against Bayer say it was too little too late.

Bayer released a statement to the San Mateo County Times stating it will “defend itself vigorously against these lawsuits.”

SOURCE: Yaz Lawsuit › California woman says Yasmin caused gallbladder failure

Strokes are the third leading cause of death in the United States, killing more than 143,500 people each year, according to the Internet Stroke Center. They also are the leading cause of serious, long-term disability. Research shows that the number of people age 20 to 45 who had a stroke 2005 was up 7.3 percent from a decade earlier.

Considered separately, birth control pills and cigarettes both increase a woman’s risk for stroke. The nicotine and carbon monoxide in cigarette smoke wreak havoc on the cardiovascular system. Estrogen is the culprit in birth control pills. Oral contraceptives, even the low estrogen varieties, cause blood to clot more easily. The higher the level of estrogen in any contraceptive pill or patch, the greater one’s risk. Another risk factor for stroke – migraines. Some studies also suggest people who suffer from migraine headaches are more likely to suffer a stroke as well.

Mix the three risk factors together, and you get a deadly combination. Women who smoke, take birth control pills and have a history of migraine headaches are 34 times more likely to suffer a stroke compared to a woman with none of those risk factors, said Thomas Hemmen, M.D., a neurologist at the University of California, San Diego, Stroke Center, to CNN. “If you’re going to take the pill, you absolutely should not smoke.”

SOURCE: Yaz Lawsuit › Birth control pills, smoking, history of migraines a deadly combination

DVT is a common disorder, but it is highly preventable, says Gary Raskob, Ph.D. and lead author of the AJPM Paper. “That’s why spreading the word about who’s at risk and the steps one can take to prevent these dangerous clots is so important,” he said.

The paper recommends strengthening surveillance of DVT and PE, and increasing public awareness of risk factors through a national campaign. For example, recent studies have identified that people who travel by airplane are at three times greater risk of developing DVT or PE. The campaign would advise air travelers to reduce their risk by staying active on the plane and staying hydrated by drinking plenty of water and avoiding alcoholic beverages.

Other risk factors include surgery or trauma, hospitalization for medical illness, cancer, obesity, smoking, pregnancy, age over 60, and a family history of blood clots. Oral contraceptives can also put users at greater risk of blood clots. To date, 59 deaths have been linked to the popular birth control pill, Yaz, also known as Yasmin or Ocella.

Symptoms of DVT include sudden pain, swelling and tenderness. PE symptoms include chest pain, shortness of breath, and sweating. For more information about these blood clotting disorders, visit the American Society of Hematology Web site at www.BloodTheVitalConnection.org.

SOURCE: Yaz Lawsuit › Medical community wants to raise awareness of preventable blood clots

According to data collected by Kissela and presented at an American Stroke Association conference last month, in little more than a decade the percentage of people in the Ohio-Kentucky area age 20 to 45 having strokes has skyrocketed from 4.5 percent to 7.3 percent. Experts say they expect national statistics to mirror those in Ohio-Kentucky.

Kissela blames poor diets that spur obesity, diabetes and high blood pressure in younger individuals. But according to Diane Book, director of the stroke program at Froedtert Hospital in Wauwatosa, another risk factor is the prevalence of birth control pills. Data from the Centers for Disease Control and Prevention indicates that birth control pill use among females age 15 to 44 has increased from 27 percent in 1995 to 31 percent in 2002.

Oral contraceptives can significantly increase a woman’s risk of stroke by two to three times more than for women who do not take birth control pills. Makers of oral contraceptives are required by the Food and Drug Administration (FDA) to warn consumers of the increased risk of strokes and other health hazards from use of their products, but more than 1,100 women injured by birth control pills have filed lawsuits against Bayer, the makers of the blockbuster birth control pill Yaz, saying the company didn’t sufficiently warn them.

SOURCE: Yaz Lawsuit › Birth control pills contribute to more strokes among young women

But a group of 50 women in Indianapolis say Bayer is wrong. They are the latest victims to file lawsuits against the drug company, alleging the new formulation of birth control pills caused heart attacks, strokes, blood clots and other health problems.

Yaz and Yasmin, also known by the generic brand Ocella, is as the company’s ads claim – different than other birth control pills. Bayer’s top-selling contraceptive drugs contain ethinyl estradiol plus drospirenone. Drospirenone is a diuretic, which the lawsuits argue can lead to dangerously high levels of potassium, which can lead to hyperkalema. Hyperkalema is a condition that can cause heart rhythm disturbances, which can trigger blood clots and sudden cardiac death or pulmonary embolism or strokes.

The lawsuits allege that Yaz and Yasmin are more aggressive than other oral contraceptives and have left plaintiffs with blood clots and pulmonary embolisms in their legs and lungs. Many had to have their gallbladders removed. Others suffered strokes.

Yet, Bayer, which reaped more than $600 million in sales in 2008, says it is not at fault. “The complaints we have reviewed so far pertain to side effects that are warned about in the labeling of all oral contraceptives, including ours,” according to a statement from Bayer spokeswoman Rose Talarie.

Sources:
UPI
Fox59
Indy Star

SOURCE: Yaz Lawsuit › Bayer claims no fault in Yaz, Yasmin injuries, deaths