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

Missing data

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

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

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

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

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

Sources:
Daily Mail
Bloomberg

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

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

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

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

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

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

Source: Fox News

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

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

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

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

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

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

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

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

Source: Everyday Health

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

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

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

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

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

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

Sources:
Business Week
Beasley Allen Ortho Evra and Blood Clots

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

Stronger warnings

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

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

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

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

Source: MSNBC.com

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

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

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

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

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

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

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

Source: Beasley Allen Personal Injury Attorney

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

Yaz

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

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

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

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

Source: WSJ

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

Sid Wolfe

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

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

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

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

Source: All Gov

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

Bayer

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

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

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

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

Source: Bloomberg

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

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

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

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

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

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

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

Source: Boston.com

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

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

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

Source: MSNBC

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

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

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

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

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

Sources:
Smart About Health
MSNBC

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

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

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

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

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

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

Source: ABC

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

* Not her real name

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

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

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

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

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

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

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

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

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

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

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

“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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“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

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

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

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

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

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

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

Even the commercials for Yaz point out that it is a different type of birth control pill, specially designed to treat premenstrual dysphoric disorder (PMDD), a severe form of PMS, as well as moderate acne. Yaz is the only birth control pill to contain drospirenone, a diuretic that can increase potassium levels in the blood and lead to serious health problems such as heart attack, cardiac arrhythmias, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, gallbladder disease, hepaic adenomas and sudden death.

Nearly 30 percent of women who take oral contraceptives take Yaz or Yasmin. Bayer claims that the oral contraceptives are safe, but that women with a family history of blood clots shouldn’t take them. The company also claims that the drugs’ labels warn consumers of the possible risks.

But the women who suffered from serious adverse events after using Yaz say the warnings were not adequate enough. An attorney representing some of the women injured by Yaz says he expects the lawsuits to become part of a class-action lawsuit that could take years to litigate.

SOURCE: Yaz Lawsuit › Indiana women sue makers of Yaz after suffering serious side effects

What Adrienne didn’t know was that while the combination birth control pill had benefits, it also increased users’ risk of serious side effects such as heart attack, cardiac arrhythmias, stroke, pulmonary embolism, blood clots, kidney failure, seizures, deep vein thrombosis, gallbladder disease, hepaic adenomas and sudden death. Adrienne believes Ocella caused her to suffer from a stroke and other serious side effects. She claims it also left her at an increased risk of developing additional side effects such as blood clots in the deep veins and lungs.

On December 28, 2009, Adrienne and her husband Kenneth, filed a lawsuit against Bayer HealthCare, the manufacturer of Yaz, and other manufacturers and distributors, seeking $75,000 from each defendant, as well as punitive damages and compensation for medical care, pain, suffering, and mental anguish.

Adrienne’s lawsuit is one of hundreds from women who say they have suffered serious side effects from Yaz, Yasmin and Ocella. The Food and Drug Administration (FDA) reports that between 2004 and 2008, more than 50 deaths have been attributed to the drugs.

SOURCE: Yaz Lawsuit › Woman claims Yaz/Yasmin/Ocella caused her stroke