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

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

Missing data

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

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

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

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

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

Sources:
Daily Mail
Bloomberg

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

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

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

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

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

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

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

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

Source: Everyday Health

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

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

Bayer

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

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

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

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

Source: Bloomberg

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

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

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

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

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

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

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

Source: Boston.com

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

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

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

Source: MSNBC

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

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

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

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

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

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

Source: Style Bistro

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

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

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

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

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

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

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

Source: WebMD

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

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

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

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

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

Source: Reuters

SOURCE: Yaz Lawsuit › Bayer loses European patent for Yasmin

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

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

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

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

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

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

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

Source: FDA

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

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

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

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

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

Source: The Times News

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

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?

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

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

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

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

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

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

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

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

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

Bayer

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

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

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

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

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

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

Bayer

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE: Yaz Lawsuit › UK blocks sales of generic Yasmin

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE: Yaz Lawsuit › FDA approves generic birth control pill

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The study 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Bayer paid German researchers to examine a database of 52,218 U.S. women using birth control pills. The researchers looked at the type of pills the women were using and the failure rates, or unintended pregnancies. The data showed that women on a 24-regimen containing drospirenone had lower failure rates compared with the standard 21-day regimen of pills containing other types of progestins.

While the news is encouraging, what isn’t are the mounting lawsuits filed against Bayer by women who say they suffered serious side effects from the pills, including blood clots, heart attacks, strokes, and gallbladder damage.

Though Bayer faces more than 2,000 lawsuits to-date, the company contends that Yaz and Yasmin carry the same serious risks as other birth control pills. Some studies suggest that the pills containing dropsirenone are more dangerous. Unfazed, Bayer has since launched two more pills containing drospirenone, Bayaz and Safyral.

The study about the effectiveness of birth control pills containing drospirenone is published in the January issue of Obstetrics & Gynecology.

SOURCE: Yaz Lawsuit › Bayer study finds Yaz, Yasmin better at preventing pregnancy

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

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

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

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

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

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

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

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

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

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

Birth control pills contain a combination of estrogen and progestin, which can trigger clotting in the blood and lead to strokes, heart attacks and blood clots. Yaz and similar Bayer pills (Yasmin, Beyaz, Natazia, Angeliq and Teva’s Ocella generic) also contain drospirenone, a diuretic, that some say can cause an increase in potassium levels in the blood and lead to hyperkalemia, which causes heart rhythm disturbances that can cause blood clots and lead to sudden cardiac death or pulmonary embolism or strokes. Diuretics have also been associated with gallbladder problems.

Claims of venus thromboembolisms (including pulmonary embolisms and deep vein thromboses) make up 40-41 percent of the lawsuits, and strokes and heart attacks make up 9-10 percent of the claims. The remaining 43 percent involve gallbladder injuries, a problem not typically associated with blood clotting, nor with oral contraceptives. But few can deny the fact that numerous young women and teenagers taking Yaz have suffered from gallbladder problems, a condition that usually affects women in their 40s.

The first lawsuits against Bayer are scheduled to face juries in September 2011. Meanwhile, Bayer is fighting back with denials as well as a lineup of new similar birth control pills such as Natazia, Angeliq and Beyaz.

SOURCE: Yaz Lawsuit › Gallbladder damage most reported problem with Yaz birth control pill

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

Click here to view the embedded video.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Because birth control pills are not always taken perfectly – every day around the same time of day. Which is why doctors have calculated another “rate” when talking about the effectiveness of birth control pills. It’s called the “real use” rate, and it reflects human errors in pill-use among women, which most often includes forgetting to take pills or simultaneously taking antibiotics that reduce the effectiveness of the pill. That “real rate” is only 91 percent, according to the Guttmacher Institute.

Loading a birth control pill with folate is an interesting concept, but some critics say by launching Bayaz, Bayer is trying to sidestep generic competition to Yaz as well as shield the public from any negative press about lawsuits that claim Yaz puts women at greater risk for serious health problems than other oral contraceptives. Bayer has held fast to its claim that Yaz is no more dangerous than other birth control pills, but more than 2,000 lawsuits indicate otherwise.

Like Yaz, Bayaz contains a diuretic that may increase potassium in the blood and lead to serious health problems such as blood clots that can cause a host of problems from pulmonary embolism, strokes, heart attacks and even sudden cardiac death. Diuretics can also cause significant problems with the gallbladder leading to gallbladder removal.

According to the Food and Drug Administration (FDA), Bayaz carries the same health risk as Yaz, raising the question whether the new pill should have been approved by the FDA in the first place.

SOURCE: Yaz Lawsuit › Bayer’s new pill with B vitamin raises questions about safety

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

Watson Pharmaceuticals

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rebecca Anderson-Hull

How could an otherwise healthy woman suffer from life-threatening blood clots? Her doctors said it was likely caused by her oral contraceptives. Rebecca had been taking Yaz, the country’s most widely used birth control pill, for two years.

“Do you think the company knew,” asked CBS 11’s Ginger Allen.
“Yes,” she replied.
“Do you blame the company?” the reporter asked.
“Yes,” Rebecca replied.

Rebecca is just one of thousands of women across the country who have filed lawsuits against Bayer, the makers of Yaz, also known as Yasmin and by the generic ocella. The lawsuits allege that Bayer was aware that its blockbuster birth control pills put women at greater risk of blood clots that could lead to heart attacks, pulmonary embolisms and strokes but failed to adequately warn them that their lives were at risk.

The lawsuits reflect a concern raised not long after the revolutionary birth control pills were introduced to the market. Bayer launched the pills with a huge advertising campaign touting the drug’s benefits for everything from premenstrual syndrome to acne. The Food and Drug Administration barked back at Bayer saying its ads were misleading, that they overstated the benefits of Yaz and minimized the serious risks associated with the pills. Bayer was fined and was ordered to launch a new ad campaign, this time clearly stating the approved uses for the pills and explaining the risk.

But it was too little, too late for many women, including Rebecca. Now Rebecca, and thousands of other victims of Yaz side effects, are demanding justice.

SOURCE: Yaz Lawsuit › Texas woman says Yaz caused brain damage

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Stewart was prescribed Yaz by her gynecologist in September 2007 to treat cramps associated with her period. Yaz is marketed as a contraceptive that also treats premenstrual dysphoric disorder (PMDD), premenstrual syndrome, as well as moderate acne. It also is the only birth control pill to contain ethinyl estradiol and drospirenone, a diuretic.

In June 2008, Stewart began to feel pain in her abdomen and learned that her gallbladder was not functioning properly. Two months later her gallbladder was removed. Stewart took a short break from Yaz until April 2009, when she resumed treatment only to go off of it again when she says the pills made her feel queasy. Severe cramping a few months later led her to go back on Yaz. Within days of resuming treatment, Stewart’s lawsuit claims she began suffering severe depression and suicidal thoughts that led her to attempt suicide on two separate occasions.

Stewart’s lawsuit names Bayer, Bayer HealthCare Pharmaceuticals, Bayer HealthCare AG, Bayer HealthCare LLC, Bayer HealthCare Corporation, Berlex Inc., and Berlex Laboratories Inc. The plaintiff seeks unspecified damages, court costs, and attorney fees.

SOURCE: Yaz Lawsuit › Woman blames Yaz for gallbladder damage, severe depression

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

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

Source: Madison/St. Clair Record

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

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

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

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

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

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

When the pills were first introduced in the United States, the commercials said they offered an alternative in oral contraception. Yaz and Yasmin are the only pills that contain drospirenone, a diuretic. The ads cited the pills as a proven treatment for premenstrual dysphoric disorder (PMDD) and as an effective treatment for moderate acne. Just as sales of Yaz and Yasmin began to soar, Bayer was penalized by the Food and Drug Administration (FDA), which argued the company overstated the benefits of their birth control pills and downplayed the risks associated with the drug. Bayer was ordered to run new ads clearly stating the risks.

Now, amid mounting lawsuits and criticism, Bayer is reaching out to consumers again, this time through a new website, www.BayerForWomen.com. “Through ongoing research, Bayer works to bring you innovative contraceptive products. We’re committed to improving your health and well-being and to bringing you the facts about the benefits, as well as the safety risks of birth control, including your own,” the site reads. It also features a video to drive home its point. In the video, blindfolded women touching a rhino trying to guess what it is. “A pipe?” “A brush?” The announcers voice plays: “Having only one point of view on anything can be misleading. So before you come to a conclusion make sure to get the full picture. Especially when it comes to your birth control.”

Bayer calls this latest marketing campaign its “unwavering commitment is to your health and well-being. We want you to have the facts on the safety and risks of your birth control, including our own,” the video continues. But considering the countless stories of women injured by the pills, one has to wonder if Bayer is more committed to protecting women, or to protecting its own image.

SOURCE: Yaz Lawsuit › Bayer launches campaign to educate women about birth control

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

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

Source: WPIX

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

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

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

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

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

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

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

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

Source: Globes

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

Kathy Perea

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

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

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

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

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

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

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

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

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

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

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

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

Leanne was diagnosed with dozens of blood clots in her lungs that at any moment could have killed her. “They were just everywhere. It was shocking…” she said. But what was even more shocking is that Leanne was told by her doctor that Yaz, the fourth-generation birth control pill that had become the most widely prescribed oral contraceptive on the market, was to blame for her malady.

Leanne has since learned she was not alone. There are thousands of women who had suffered as bad a fate as she. Some didn’t survive. More than 1,000 lawsuits have been filed against Bayer, the maker of Yaz, claiming the drug company didn’t adequately warn women of the dangerous side effects associated with Yaz.

Bayer maintains that Yaz is no more dangerous than other birth control pills on the market. Victims discount that claim. Despite the lawsuits, Bayer recently updated the labels of Yaz and its other birth control pill, Yasmin, to include warnings of serious adverse events including blood clots.

While Leanne was lucky to survive her blood clots, her life is not the same. The clots remain in her lungs, causing her shortness of breath, and she has to take powerful blood thinners, which raise her risk of bleeding so she has to limit her activities. “I’m very, very angry,” she said. “I might not ever be 100 percent, and it could have been avoided.”

SOURCE: Yaz Lawsuit › Yaz victim says blood clots ‘could have been avoided’

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

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

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

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

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

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

Source: Daily Record

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

Bayer Schering Pharma

“Yasmin’s positive benefit/risk profile remains unchanged. Our wealth of post-marketing safety data includes more than 42 million women with years of drospirenone use, as well as two epidemiological studies involving more than 120,000 oral contraceptive users. We are convinced that Yasmin is a good choice for women seeking convenient and reliable contraception if they use the product as directed. Bayer will continue to provide information which will support health care providers and their patients in taking informed decisions about appropriate treatment choices,” said Kemal Malik, MD, Chief Medical Officer at Bayer Schering Pharma, in a press release issued by the drug company.

The news is hardly reassuring for the hundreds of women who have been injured by Bayer’s Yasmin who have filed lawsuits in both the United States and Canada. They contend that flashy advertisements from the company downplayed the serious side effects of the drug, and that its formulation with the added diuretic made women more susceptible to suffering gallbladder problems, blood clots and other serious ailments. After strict orders and a stiff penalty by the Food and Drug Administration, Bayer has since bankrolled another advertising campaign aimed at clarifying its approved usages and explaining the serious side effects it may cause.

SOURCE: Yaz Lawsuit › Yasmin birth control pill to receive label changes

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

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

The gallbladder’s sole function is to store bile, a dark green to yellowish brown fluid produced by the liver to aid in the digestion of fats in the small intestine. When the gallbladder becomes diseased, it can become inflamed and produce gallstones. A gallbladder attack occurs when the stones block the flow of bile. These attacks can cause excruciating pain and oftentimes the only remedy is to have the gallbladder removed.

Common contributing factors include weight gain or loss, hypothyroidism or thyroid disease, high cholesterol, alcohol intake, family history of gallbladder disease, and diabetes. However, use of estrogen and birth control pills are also considered risk factors as estrogen increases the concentration of cholesterol in the bile.

Gallbladder disease is one of the many serious adverse events reported with use of one particular brand of birth control pill, Yaz, also known as Yasmin and Ocela. An estimated 1,100 lawsuits have been filed against Bayer, the makers of Yaz, by women who say the birth control pill caused them to develop gallbladder disease, blood clots, seizures, cardiac arrhythmias, heart attacks, or strokes. As many as 59 deaths to date have been linked to Yaz.

SOURCE: Yaz Lawsuit › Birth control pill Yaz linked to gallbladder disease

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is Bayer’s top-selling oral contraceptive and one of the most popular choices among women and doctors for birth control. Last year, the company raked in more than a billion dollars from the sale of Yaz. The pill is different from other birth control pills because it contains a diuretic, drospirenone, that can raise the potassium in blood to dangerous levels and cause to blood clots that can lead to sudden cardiac death, pulmonary embolism or strokes.

The lawsuits allege that Bayer didn’t do enough to warn women about the serious health risks to women who take Yaz. Even the Food and Drug Administration (FDA) cracked down on the drug company, saying advertisements for the birth control pill were overstating its benefits and understating the risks involved. Yaz commercials touted added benefits such as treatment for symptoms of premenstrual syndrome and acne. Since the FDA crackdown, Yaz was forced to run a series of ads clarifying the use of Yaz and clearly stating the dangers of taking the drug.

Victims say it’s too little, too late.

Bayer’s 2009 annual report does not specify how many women have died from the drug, but the FDA puts the count as high as 59.

SOURCE: Yaz Lawsuit › Bayer facing more than 1,100 lawsuits from women injured by Yaz

Yaz, also known by the brand name Yasmin and the generic brand Ocella, is a different type of oral contraceptive that combines ethinyl estradiol with the diuretic drospirenone. Some health professionals say that the addition of drospirenone in birth control raised the potassium level in users’ blood. This increase in potassium can lead to hyperkalemia and cause heart rhythm disturbances that can cause blood clots that can cause sudden cardiac death or pulmonary embolism or strokes. At least 50 women and their family members have filed suit against the Bayer claiming the drug manufacturer knew of the potential risks but did not properly warn women.

Bayer has argued that it sufficiently warned women that Yaz, like all birth control pills, carries a risk of life-threatening side effects.

Last year, Bayer, after getting its hand slapped by the Food and Drug Administration (FDA), shelled out $20 million to air advertisements to clarify the drug’s use. The FDA argued the company’s previous ads misled consumers by broadening the drug’s indication. The commercials promoted Yaz as a treatment for PMS, a condition for which it was not indicated, and acne, a condition in which Yaz has a limited indication. The FDA also said that the drug’s risk information was not stated clearly and was clouded with distracting visuals, background music and other “competing modalities.”

Meanwhile, Yaz remains on the market and continues to rake in money for Bayer. Yaz scored $9 billion in the first nine months of 2009, a sizable increase over the $600 million it made in 2008.

SOURCE: Yaz Lawsuit › Bayer pockets billions from dangerous birth control pill Yaz

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