Study: Yaz Has Higher Risks of Blood Clots

A new study of 1.3 million Danish women over nine years adds to the evidence that some newer birth-control pills, including the best-seller Yaz, have a higher risk of causing potentially dangerous blood clots.

Newer pills containing drospirenone, a synthetic hormone, were linked to a six-fold increase in the risk of venous thromboembolism, which is the formation of clots in the lower leg or thigh that can break loose and travel to the lungs.

That risk was compared with a three-fold increase in women using older contraceptives containing the synthetic hormone levonorgestrel. The studywas published Tuesday on the Web site of BMJ, formerly known as the British Medical Journal.

A BMJ editorial added, “It is crucial, however, not to exaggerate the risk — oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality.”

The Food and Drug Administration is already studying the possible increased risk of blood clots with pills containing the drospirenone. The F.D.A. says its preliminary results suggest a 1.5-fold increased risk compared with other hormonal contraceptives, to about 10 women in 10,000 from 6 women in 10,000.

Studies have differed, though. Some found no increased risk among women taking the newer pills. The F.D.A. has scheduled a joint meeting of two advisory committees on Dec. 8 to review the risks and benefits.

Bayer, the German drug company that makes Yaz and the related product Yasmin, has said the two have similar clot risks to other combination birth control pills, including levonorgestrel. The company updated its labels last year with that indication.

The new study, sought by the European Medicines Agency, challenges that finding.

Bayer, in a brief statement Wednesday, said it is “currently evaluating this publication and cannot comment at this time.”

Bayer also said its clinical data from more than 15 years supports the company’s assessment that its hormonal birth control products are safe and effective when used as indicated and that the risk of venous thromboembolism is similar to that from taking any other low-dose estrogen product studied.

Thousands of women have sued Bayer, contending that they have suffered injuries from taking Yaz or Yasmin. Bayer introduced Yasmin in 2001 and Yaz in 2006. Yaz contains the same amount of drospirenone but a smaller amount of ethinylestradiol, a synthetic estrogen commonly paired with progestins in birth control pills.

The Danish study found essentially no difference in the risk of venous thromboembolism between Yaz and Yasmin, and in both cases, about double that of some other hormonal birth control pills.

Some of the numbers were small, though. The study found 23 reported events of venous thromboembolism in the Yaz group, confirming 16 of them with medical records, compared with 78 reported events, confirming 57 of them, for users of older levonorgestrel. The latter group was more than four times larger than the Yaz group. That left levonorgestrel with more certainty about a relative risk of the clot of two to four times that of nonusers, while Yaz had a wider range of risk, four to 11 times that of nonusers, within statistical significance, the study said.

The researchers estimated 2,000 women would need to change birth control pills to prevent one incident of venous thromboembolism in a year.

Yaz has been marketed and F.D.A. approved for quality of life treatment for acne and severe premenstrual symptoms, in addition to birth control benefits. The drugs have had worldwide sales of $1.47 billion last year.

Yaz sales in the United States declined earlier this year, the company said, blaming generic competition.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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Just How Safe is Yaz? Women Need to Know!

The oral contraceptive Yasmin was released in 2001 by the pharmaceutical company Bayer, followed byYaz in 2006. They differ from other birth control pills in the synthetic progesterone they utilize, drospirenone, which is marketed as less likely to cause weight gain and bloating than other birth control pills. Yaz soon became the most popular birth control pill in the U.S., due in part to a widespread advertising campaign promoting the drug as what theNew York Times dubbed “a quality of life treatment,” claiming it could also clear up acne, prevent bloating and ease the depression and anxiety associated with both PMS and the controversial condition of PMDD. It prevents pregnancy at the same rate of effectiveness as all other oral contraceptives.

In 2009, the FDA requested that Bayer distribute a corrective advertisement to counter its aggressively screened commercials that were said to be making misleading assertions about the capabilities of the drug, promoting it for unapproved uses and making light of the more serious health risks (such as blood clots). However, in 2010 the drug remained the second-best-selling Bayer product, bringing in $1.5 billion in sales.

As of January 2012, there are approximately 10,000 lawsuits against Bayer by women who have suffered blood clots and by the families of those women who have died whilst taking Yaz or Yasmin. It is considered the most complained-about drug on the Internet, with thousands of women voicing concerns in online forums and support groups over health issues both physical and emotional. Jane Bennett and Alexandra Pope, authors of The Pill: Are You Sure It’s for You?, characterize many of these problems as “quality-of-life-threatening.” I have written extensively on my own experience with Yasmin in my blog, Sweetening the Pill, and for the UK Independent and have been quoted in Fabulous magazine the Washington Post. 

Two studies conducted with funding from Bayer revealed that Yaz and Yasmin held no higher risk of blood clots than other birth control pills. However, last month it was revealed that five other studies undertaken independent of Bayer suggested a 50-to-75 percent increased risk of clots for those taking these birth control pills in comparison to others. A former FDA commissioner, David Kessler, charged that Bayer deliberately withheld data about this early on in order to push through the drugs’ approvals. In response, the FDA called an advisory committee to evaluate the safety of birth control pills containing drospirenone. The decision had the potential to cause the drugs to be pulled off the market, but the panel voted by a four-person margin that the drugs’ benefit outweighed the risks.

Yet a government watchdog group, the Project on Government Oversight (POGO), conducted an independent investigation that revealed three of the advisors on the FDA panel had research or other financial ties to Bayer. A fourth advisor was connected to manufacturing the generic version of these pills. All four voted for Yaz and Yasmin to continue to be prescribed by doctors. POGO asked the FDA that a new advisory committee be brought together to make another assessment.

Should these developments impact women’s perspective on the birth control pill? Should we consider that use of the Pill for pregnancy prevention, let alone acne or PMS, is still today, as women’s health activist Barbara Seaman wrote in her 1969 book The Doctors’ Case Against the Pill, “like tinkering with nuclear bombs to fight off the common cold”?

Says Ms. blogger Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research:

I’m surprised there has not been a broader call for more research, or wider public discussions of the risks of this pill. When a drug company is withholding data and 10,000 lawsuits are pending, more than research is needed. I can’t help but wonder why we’re not seeing Congressional hearings–akin to the 1970 Nelson Pill Hearings–again, and more of an outcry from both physicians and patients.

Much of the media coverage of these recent developments and research was quick to assert the unimportance of women’s concerns. It was repeatedly reported that, when compared to the risk of blood clot development associated with pregnancy, the risk produced by taking any oral contraceptive–including Yasmin or Yaz–is of little concern. This is misleading in that it suggests there are only two states in which young women can choose to live: on birth control pills or pregnant. The fear has been voiced that any discussion of the negative impact of the Pill will prompt women to come off of it and fall unintentionally pregnant. No coverage that this writer has read discussed a comparison with non-hormonal contraceptive alternatives–which, of course, hold no increased risk of blood clots. Some of these alternatives are just as effective in preventing pregnancy as oral contraceptives, and others are more so.

According to Laura Wershler, veteran pro-choice sexual and reproductive health advocate and board director of the Canadian Federation for Sexual Health,

We need to reframe the idea that hormonal birth control is the gold standard of contraception. If women are quitting the Pill, and they have every right to do so, and they are not using alternative methods of birth control effectively, that’s proof positive that what we are teaching about contraception is incomplete and ineffective. If we make the Pill the ‘right’ choice, then why should we be upset when women stop taking it and get pregnant?

It is often claimed within news stories that the Pill “regulates” a woman’s menstrual cycle, when it, in fact, stops and replaces the cycle. All of this propaganda for the Pill is extremely misleading, and it further breeds a lack of confidence to know that Bayer paid women’s magazines to advocate for Yaz. Such actions blind women to their choices and to understanding how their bodies work. There is much research that supports the health benefits of consistent (typically monthly) ovulation, which can be found through the Centre for Menstrual Cycle and Ovulation Research.

The absence of education in body literacy is a major factor in unwanted pregnancies. However, this lack of education is beneficial to some: It helps sustain the billion-dollar profits of pharmaceutical companies.

Photo is the cover of The Pill: Are You Sure It’s for You?

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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Yaz® Drug Injury Lawyer

The Yaz® birth control pill has been on the market since 2006. Yaz is taken orally once daily to prevent pregnancy.
Yaz differs from other birth control methods because it contains a progestin hormone called drospirenone, which can increase potassium levels in the bloodstream.
Yasmin®, a birth control drug very similar to Yaz, has been on the market since 2001. It contains the same hormone as Yaz and is associated with the same health issues. Ocella® is sometimes supplied by pharmacies instead of Yaz or Yasmin, and carries the same risks.
Dangerous Side Effects
Yaz has been linked with serious adverse heart problems in women taking the drug. In a reprimanding letter sent to the manufacturer of Yaz, the Food and Drug Administration (FDA) warns of blood clots, heart attack, stroke, and gallbladder disease in Yaz users (1).
The FDA goes on to say, "Yaz has additional risks because it contains the progestin, drospirenone [...] can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking Yaz must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives (1)."
What Have Yaz Studies Revealed?
The British Medical Journal (BMJ) released a report revealing that blood clots in Yaz and Yasmin are as frequent as with third generation birth control pills. Third generation pills had an established warning for blood clots, but Yaz and Yasmin did not yet have such a warning.
The FDA then released results from a study that included over 800,000 American women who were taking various forms of birth control between 2001 and 2007. The research revealed that women taking Yaz had a 75 percent higher chance of getting a blood clot than women taking older forms of birth control pills.
Elevated Potassium Levels
Yaz also has been linked to a condition known as hyperkalemia. Hyperkalemia is a condition that describes abnormal levels of potassium in the bloodstream, which can lead to fatal arrhythmias. Arrhythmias are disorders of the speed at which the heart beats.
Heart Attack, Stroke, and Blood Clots
Yaz and other oral contraceptives present an increased risk of heart attack in users (2), especially in smokers. In addition to heart attack, there is an established link between oral contraceptives and blood clots and stroke.
Quality Control Issues
U.S. health regulators warned the manufacturer of Yaz about its quality control issues at a plant that makes several of the ingredients in Yaz. The FDA said inspectors found testing problems at the company's plant in Berghamen, Germany. One of the drugs on the list that may not be up to standards is Yaz's main ingredient, drospirenone (4).
Bloomberg reports that lawsuits have been filed against the manufacturer of Yaz, claiming that Bayer unlawfully promoted the drug by concealing side effects, including blood clots, heart attacks, and pulmonary embolisms in Yaz users.
Furthermore, a Swiss health regulation investigation into the death of a woman who took Yaz and died of a blood clot in her lung is currently underway.
Yaz Marketed for Unapproved Uses
In January 2009, the FDA required the maker of Yaz, which ran commercials claiming Yaz could be used to cure headaches and severe acne (uses that are not approved by the FDA), to launch a campaign correcting those false claims.
The FDA said, "These violations are concerning from a public health perspective because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz (1)."
Yaz is approved for use as an oral contraceptive, to treat moderate acne in women ages 14 and older, and to help reduce some emotional and physical symptoms of PMDD (a condition in which a woman has severe depression symptoms, irritability, and tension before menstruation). Yaz is not approved to cure PMS, severe acne, or all of PMDD's symptoms.
Despite the dangers, marketing violations, and manufacturing issues Yaz has been associated with, it is still on the market today.
We Want to Help
If  you or someone you care about took Yaz and suffered a blood clot, stroke, or heart attack, someone at our law firm would like to speak with you. We may be able to help.
Sources:

1. "Yaz (drospirenone and ethinyl estradiol) Tablets Warning Letter to Bayer HealthCare," from the Food and Drug Administration (www.fda.gov).
2. "Yaz  Prescribing Information," from the Yaz warning label. Accessed 4/3/09 via www.yaz-us.com.
3. "Hormonal contraception and risk of venous thromboembolism: national follow-up study" from the British Medicine Journal. Accessed 8/20/09 via www.bmj.com.
4. "FDA warns Bayer over German manufacturing plant," from The Associated Press via www.yahoo.com.

Yaz® and Yasmin® are registered trademarks of Bayer Pharmaceuticals. Ocella® is a registered Barr Laboratories, Inc. Trademarked names are used only to identify the productions in question.
This law firm is not associated with, sponsored by, or affiliated with The Associated Press, Barr Laboratories, Inc., Bayer Pharmaceuticals, the British Medicine Journal, the Food and Drug Administration, or Yahoo!

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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How We Can Help

If you or a loved one has suffered serious injury including blood clots, deep vein thrombosis, pulmonary embolism, stroke, organ failure or death after taking Yaz, Yasmin, Ocella, Zarah or Gianvi you may be entitled to compensation.  An experienced pharmaceutical attorney can help evaluate your claim and give you the advice you need to go forward with your case.
The Yaz / Yasmin attorneys at Jackson Allen Williams, LLP are familiar with birth control side effects litigation and can help you understand your rights.  Our Yaz/Yasmin/Ocella/Zarah/Gianvi litigation team is already representing women throughout the United States who have suffered serious side effects from Yaz, Yasmin, Ocella, Zarah or Gianvi. 
If you would like to speak with a Yaz lawyer about your legal rights, contact us now for a free Yaz lawsuit consultation.

 In personal injury cases where individuals have been injured by potentially defective products like Yaz, Yasmin, Ocella, Zarah or Gianvi, it is important to act quickly to preserve evidence and investigate the the injury.  Further, you must file a Yaz / Yasmin lawsuit before the statute of limitations expires.  If you delay filing your claim, and the statute of limitations expires, you may lose your rights to compensation.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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IndiYaz A Jones Cartoon Teaches Sales Reps About Their Drug

At Bayer, company executives have released a series of Saturday-morning-style cartoons which they hope will motivate their sales reps to continue marketing their birth control drugs. The most popular of these cartoons is “IndiYaz A Jones and the Temple of Estradiol.” According to Pharmalot.com, estradiol is a hormone that is contained in the Yaz contraceptive which is sold by Bayer. The cartoons were created by an animator at Bayer in 2008, and were only meant for internal training purposes. They contain a variety of different pitches that can be imitated and articulated by the sales representatives at Bayer.

The cheap cartoons contain dialogue about the drug in a staged format, as if IndiYaz A Jones himself is searching for the pills. The cartoons are supposed to mimic the classic Indiana Jones movies with Harrison Ford, and even contain mock animated versions of other TV personalities like Oprah. The cartoons are part of a series that has been labeled Segmentation Tonight, a reminiscent title that is supposed to refer to “Entertainment Tonight. The Oprah Winfrey-type character reminds sales representatives that they should never bash their competitors. These odd cartoons were only used for training purposes, and were not intended to be released to the public. When a YouTube user got a hold of the episodes and posted them online, they were promptly taken down.

Yaz, Ocella, and Yasmin birth controls can be dangerous, no matter what an experienced sales representative or a cartoon tells you. They can come with horrific side effects that leave women with deep vein thrombosis, pulmonary embolism, or a stroke. If you have been harmed by taking one of these contraceptives, you should seek medical attention and a personal injury attorney right away. By hiring a Jackson Allen & Williams lawyer to work on your case, you will be able to battle Bayer and seek compensation for your pain and suffering. We are passionate about putting an end to these horrible contraceptives that cause so many adverse effects. Talk to us today to seek damages!

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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Current Yasmin and Yaz Label Warnings Are Inadequate

Seated around a U-shaped configuration of tables sat the 26 member FDA Advisory Committee — all scientists or physicians gathered to discuss the risks of birth control pills containing DRSP. They focused on the risks as described in recent studies, including the FDA’s own study that looked at over 800,000 women during a six year time period. The results of the FDA study concluded that new users of Yasmin may be twice as likely to experience a blood clot as users of other birth control pills containing the progestin Levonorgestrel.

During the first two hours of the hearing, an FDA representative presented an overview of the studies Bayer conducted after Yasmin was introduced to the market. The Bayer studies suggested that Yaz posed little additional risk. Then an FDA-paid scientist presented the results of the study that she conducted, showing a greater risk. But rather than bolstering her results with the six independent studies also showing a greater risk, the FDA-paid scientist gave those other studies – including those done by Drs. Jick of the U.S., Parkin of the U.K. ,Vlieg from the Netherlands and Lidegaard of Denmark– short shrift. Rather she focused on trying to explain away the conflicting results between the FDA’s own study and the Bayer-sponsored studies. Possible explanations she offered: FDA study design weaknesses and channeling. (Channeling is the selective prescribing of Yasmin to high-risk patients such as women with polycystic ovary syndrome.)

The FDA teed up nicely the topics for more than two hours of presentations by the German- owned Bayer representatives. Flanked by more than thirty Bayer suits seated neatly in five rows, Bayer’s vice president of US Medical Affairs, Leo Pouffle, with his stunted German accent led the charge. A regimen of six head-set tethered technicians each peering over his or her laptop supplied Dr. Poufle and other Bayer speakers with plenty of power-point ammunition. Bayer’s well-rehearsed battalion calmly, courteously and methodically casted doubt on the FDA study.

Members of the public were then allowed to speak. Each was limited to three minutes. Family members of Yaz victims described how Bayer robbed them of their young, fit, active healthy daughters who died after suffering a pulmonary embolism – caused by taking Yasmin or Yaz. Members of other women’s health organizations spoke up about the unnecessary health risks posed by DRSP. Two scientists testified, including Bert Gerstman, an epidemiologist who criticized the design of Bayer’s studies. Unfortunately, the public comment had little effect on today’s outcome.

After two more hours of questions and answers about the studies, the FDA advisory committee decided that Bayer’s current labels do not adequately reflect the risk/benefit profile for these products. That was expected, since the results of the FDAs own study are not described in the current warnings. But to the disappointment of consumer advocates, the committee did not push for black box or even tougher warnings. The members merely recommended that the FDA draft simpler warnings with an updated summary of recent conflicting study results.

One FDA committee member pressed Bayer’s vice president of US Medical Affairs on whether Yasmin and Yaz are more effective than other oral contraceptives at preventing pregnancy. If the drug was more effective, that might justify their higher level of risk. Dr. Plouffe deflected the question twice. But when the committee asked a third time, he admitted that Yasmin and Yaz are no more effective that other combination oral contraceptives.

Nonetheless, the committee voted 15 to 11 that the benefits of Bayer’s DRSP-containing oral contraceptives outweigh their risks. Apparently, some committee members, mostly clinicians, needed no evidence that Yasmin and Yaz are more effective than other oral contraceptives to come to that conclusion. They were satisfied that Yasmin and Yaz are as effective as other oral contraceptives at preventing birth and refused to accept reported results that Yasmin and Yaz pose greater risks of VTE than other birth control pills. More sympathetic to the consumer’s plight, the scientist and epidemiologists on the committee were dissatisfied with Bayer’s studies and offered their opinions that Yaz and Yasmin posed risks that were simply unacceptable.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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Pfizer Recalls One Million Packs of Birth Control Pills

On January 31, 2012, the FDA posted a safety recall of one million packs of oral contraceptive pills because the pills may not be effective in preventing pregnancy. The recall covers Pfizer birth control Lo/Ovral-28 and generic versions of the drug (Norgestrel and Ethinyl Estradiol) with expiration dates between July 2013 and March 2014. Recalled pills may be labeled under theAkrimax Pharmaceuticals brand. Exact lot numbers for the recalled products are available on the FDA Safety Recall website.

According to Pfizer, the problem was caused by both mechanical and visual inspection failures on the packaging line which caused pills to be packaged out of order. Generally, birth control packets contain three weeks of contraceptive pills that contain hormones followed by a week of sugar pills that do not contain hormones. As a result of the packaging defect, some pill packs contained too many sugar pills and the pills that contained Norgestrel and Ethinyl Estradiol were placed at the wrong point of the cycle to effectively prevent pregnancy. The FDA recommends that consumers return the recalled products to the pharmacy where they were purchased.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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Yaz Trial Delayed

he first Yasmin/Yaz trial involving a woman who suffered a pulmonary embolism after taking the birth control pill scheduled to begin next week has been delayed by Judge Herndon, the federal judge presiding over thousands of lawsuits. In an order issued December 31, Judge Herndon indefinitely continued the start of that case and ordered the parties to meet with a special mediator in an attempt to negotiate a settlement for the litigation.

Judge Herndon determined that the best interests of the litigation will be better served by delaying the start of the bellwether trial, which was designed to help the parties gauge how juries are likely to respond to evidence that will be presented in many of the cases. He appointed ProfessorStephen Saltzburg of George Washington School of Law to serve as Special Master for purposes of mediating the entire litigation. The leadership teams for the plaintiffs and Bayer were ordered to meet with Saltzburg and to negotiate in good faith. Professor Saltzburg was recently the mediator that helped reach settlements in thousands of lawsuits over the side effects of Seroquel; an antipsychotic by AstraZeneca which many say causes diabetes and weight gain. In July, AstraZeneca reported it had reached settlements in more than 28,000 of those claims.

Over 10,000 women have filed a lawsuit against Bayer alleging that they suffered injuries as a result of the drug maker’s failure to adequately warn about the side effects of Yaz, Yasmin and other drosperinone-based birth control pills made by Bayer. Drospirenone is a newer type of progestin that is used in combination oral contraceptives that also include estrogen.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

Read more »

"Yaz, Yasmin and Ocella Birth Control Drugs may have Serious Side Effects

Yaz/Yasmin/Ocella Birth Control Side Effects Lawsuits

Yaz, Yasmin, Ocella Lawsuits, Side Effects: Gallbladder Damage, Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Blood Clots, Heart Attacks, Strokes, Death

Yaz, Yasmin and Ocella Birth Control Drugs may have Serious Side Effects

Yaz, Yasmin and Ocella Birth Control Drugs

September 26,2011: The U.S. Food & Drug Administration (FDA) issued an updated Drug Safety Communication informing the public that it "remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills." The FDA is advising patients to speak to their healthcare professional about the risk of blood clots before deciding which birth-control pill to use. This alert was updated on October 27, 2011 in a FDA Safety Medwatch If you have used Yaz/Yasmin or Ocella and have experienced any of these side effects, we urge you to contact us today at1-800-LAW-INFO (1-800-529-4636).

FDA Approved Oral Contraceptives Containing Drospirenone

Brand name Generic name  Beyaz Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg  Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.03 mg  Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.02 mg  Gianvi Drospirenone 3 mg and ethinyl estradiol 0.02 mg  Loryna Drospirenone 3 mg and ethinyl estradiol 0.02 mg  Ocella Drospirenone 3 mg and ethinyl estradiol 0.03 mg  Safyral Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg  Syeda Drospirenone 3 mg and ethinyl estradiol 0.03 mg  Yasmin Drospirenone 3 mg and ethinyl estradiol 0.03 mg  Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg  Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg

The Yaz/Yasmin/Ocella group of birth control drugs, an oral contraceptive, contains progestin drospirenone or drsp. Drsp is a diuretic which may elevate the levels of potassium in the blood stream. Unsafe levels of potassium in the blood stream, also known as hyperkalemia, can disrupt heart rhythms and slow the flow of blood throughout the body. Drospirenone is also a diuretic and if the body is dehydrated this can lead to blood clotting. Symptoms of hyperkalemia include nausea, fatigue, muscle weakness or tingling sensations.
Drospirenone and/or elevated potassium side effects may include pulmonary embolisms, deep vein thrombosis or DVT, blood clots, heart attacks, strokes, damaged kidneys, damaged gallbladder, abnormal heartbeat, and even death. If you experienced any of these side effects while taking Yaz, Yasmin, or Ocella, please contact us right away for a free case evaluation.

New reports highlight problems with Yaz Yasmin Ocella Side Effects

Swiss media is reporting that nearly 200 women have died while taking Yaz and Yasmin, Bayer’s blockbuster contraceptives. 190 women have died according to BNET, and Bayer’s shareholders are furious with how Bayer marketed the drugs. At the annual meeting on April 29, a shareholder motion is expected however, said BNET, but the motion will likely not pass. Still, shareholders are hoping that the motion will bring attention to Bayer's marketing of the contraceptive medication problems.
Over 6,850 lawsuits have been filed since February of this year. These lawsuits claim that the birth control pills led to potentially lethal blood clots and gall bladder damage and failure, said BNET, citing page 242 of Bayer’s annual report. More lawsuits are expected. While the total number of deaths cited in the lawsuits is not known, a German-language report on Swiss Television claimed that a search of the U.S. Food and Drug Administration (FDA) adverse event database discovered 140 fatalities linked to Yasmin and 50 to Yaz, said BNET. Because the database includes unconfirmed reports, said BNET, the actual number of fatalities linked to Yaz and Yasmin might be lower; however, release of those numbers and the number of lawsuits filed will create challenges for the drug maker, especially when it attempts to defend its birth control pills as being safer than older birth controlmedications.
Through this Bayer has been touting two studies it had commissioned, citing these studies as proof that their birth control drugs are safe. This contradicts other uncommissioned studies that have found the contraceptives Yaz and Yasmin increase the risk of blood clots more than other types of birth control pills.

Yaz Yasmin Side Effects May Lead To Stroke

The Yaz, Yasmin & Ocella lawsuit deals with the birth control pills’ nasty side effects, which may be putting millions of young women at risk. Side effects of Yasmin and Yaz may include stroke, heart attack and even death.  Bayer USA, the maker of Yaz and Yasmin birth control pills, has already come under fire from the Food & Drug Administration (FDA) for running TV commercials that minimize the possible health consequences and side effects of Yazand Yasmin.
In the summer of 2009 several lawsuits were filed by women who claimed Yaz birth control made them sick.  They allege Bayer overstated the benefits of the drug and failed to warn that it could put women at risk of serious injury from Yaz birth control side effects. It is expected that many such Yaz class action lawsuits will be filed in the future.
Our Yasmin and Yaz Side Effects lawyers are offering free case evaluations to victims of this drug.  If you or someone you love suffered from Yasmin or Yaz birth control side effects, you may be eligible for compensation for medical bills, lost wages and pain and suffering.  We urge you to contact our Yaz lawyers right away to protect your legal rights.

Ocella/Yaz/Yasmin Side Effects

Yaz is one of the best-selling oral contraception pills in the U.S., with 2007 sales of $616 million.  Yaz is a combination birth control pill that contains estrogen and progestin.  Yaz is considered a low-dose pill, in that it contains .035 milligrams or less of estrogen.
Yaz received FDA approval as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in October 2006.   Finally, in January 2007, Yaz was approved to treat moderate acne in women who desire an oral contraceptive for birth control.

Yaz Risks

Evidence is growing that Yaz carries serious health risks. Yaz contains a synthetic type of progestin called drospirenone.   According to the FDA, drospirenone can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood, in high risk patients.   This condition may result in potentially serious heart and health problems.
Because of this risk, women with conditions that predispose them to hyperkalemia (such as renal insufficiency, hepatic dysfunction and adrenal insufficiency) should not take it as they may be in danger from the side effects of Yaz. Women taking Yaz must also be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives.
In order for Yaz users to avoid high potassium levels, blood tests should be drawn every few months. Most women who take Yaz don’t know about taking these blood tests because the instructions to take the tests are given in a small package insert with the birth control - something few people ever read.
Women involved in Yaz lawsuits have claimed that they suffered from a variety of serious ailments.  These include deep vein thrombosis, pulmonary embolism, and stroke.  Yaz has also allegedly been associated with heart attacks and deaths in young women.
Finally, the FDA's Adverse Event Reporting System (AERS) lists a variety of other side effects of Yaz reported by users.  These include severe allergic reactions, rash, hives, itching, difficulty breathing, chest tightening, fainting, irregular heartbeat, liver problems, unusual or severe vaginal bleeding, unusual tiredness or weakness, vaginal irritation or discharge, and vision changes.

Bayer Yaz Gastrointestinal Side Effects and Risks

Gastrointestinal problems are another possible Yaz side effect that can make a young woman's life miserable. It is estimated that approximately 10 percent of Yaz users will suffer some sort of digestive issue while taking this contraceptive. These problems can include digestive tract inflammation and gastroenteritis that is accompanied by nausea, vomiting, diarrhea and abdominal pain. Some of the milder Yaz gastrointestinal problems frequently occur only during the first several months of taking the pills.

Bayer Yaz Ads Downplay Yasmin Side Effects and Risks

Despite the known side effects associated with Yaz, Bayer has downplayed risks when marketing the drug.   In October 2008, the FDA cited two Yaz commercials for deceptive claims. In a warning letter, the FDA faulted Bayer for overstating the benefits of Yaz.  The FDA also criticized the ads for containing fast-moving images and background music that might be distracting to viewers.  These elements were aired while information about potential Yasmin side effects - including potentially life-threatening blood clots - was described. The FDA warning letter said the television commercials minimized the risks posed by Yaz.
Bayer quickly agreed to stop running the offending Yaz ads.  As a part of an agreement with the FDA and Yaz attorney generals in 27 states, Bayer began running a new ad campaign in February 2009 to correct information conveyed by the deceptive Yaz commercials.  The Yaz lawsuits settlement also required that Bayer submit all Yaz ads for federal screening before they appear.
While the FDA has required drug makers to pull deceptive advertising before, it is highly unusual to require companies to run corrective spots, such as the one introduced by Bayer for Yaz.  Clearly, the agency believed that the popularity of the Yaz brand and the misleading ads had demanded this extraordinary remedy.

Legal Help for Victims of the Side Effects of Yaz - Yaz Lawyers

If you or someone you love took Yaz and suffered from serious side effects, including deep vein thrombosis, pulmonary embolism, stroke, heart attack, or hyperkalemia, you have valuable legal rights.  Please fill out our online form, or call (1-888-925-3852) to discuss your case with a Yaz attorney.

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