En Español [YAZ Y YASMIN ANTICONCEPTIVOS]
Yasmin/Yaz Birth Control Side Effects
As of March 2012, approximately 12,000 lawsuits have been brought against Bayer HealthCare Pharmaceuticals, Inc., the manufacturer of Yasmin, Yaz, Beyaz and Safyral, alleging an increased risk of blood clots (deep vein thrombosis (DVT), pulmonary embolism (PE)) and gallbladder problems.
Ocella, the generic version of Yasmin, is also associated with serious side effects, some of which are potentially fatal. All of the oral contraceptives containing ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP) have been linked to:
- Blood Clots
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism
- Gallbladder Disease
- Cerebrovascular Accidents (CVA)
- Heart Attack
- Myocardial Infarction
Life-threatening side effects such as Yasmin DVT and Yasmin Pulmonary Embolism have led to thousands of Yaz and Yasmin claims against Bayer Healthcare Pharmaceuticals for compensation. Lawsuits allege that the drugmaker failed to adequately warn patients and physicians of increased risk of serious side effects associated with the use of Yasmin and Yaz compared to safer oral contraceptives. At issue is that Bayer did not adequately disclose the dangerous consequences of using its birth control medication containing drospirenone, a new synthetic type of progestin used in the oral contraceptives in combination with estrogen.
Yaz and Yasmin Lawsuits: DVT, Blood Clots, PE
By July 2012 Bayer had settled almost 1,900 cases alleging that its Yasmin and Yaz contraceptives caused blood clots that can lead to heart attacks and strokes, according to Bloomberg.com. Bayer had paid $402.6 million in settlements of one category of clot cases, for an average of about $212,000 a case. The drugmaker also said it had set aside $610.5 million to settle Yaz cases, which is more than double it had reserved for Yaz cases in the two previous years.
By February 1st, 2012, about 12,000 lawsuits were pending in the US against Bayer, on behalf of people who have suffered personal injuries, some fatal, as a result using Yasmin and/or Yaz. As of July 2013 Bayer had settled the claims of 6,760 US plaintiffs for a total of $1.4 billion, according to the Chicago Tribune September 15, 2013.
Most lawsuits filed to date against the maker of Yaz have been consolidated into a Federal Multi-District Litigation (MDL) court in Illinois, so that each case can be examined separately. They have been consolidated under the case Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100).
(Attorneys believe that an MDL, rather than a class action lawsuit, will likely be more successful for those victims who have suffered substantial injuries.)
Although personal injury attorneys nationwide are working on settling Yasmin/Yaz DVT and pulmonary embolism lawsuits victims who have not yet filed a claim still have the right to seek compensation.
You Can Still File Yasmin and Yaz Claims
Personal injury attorneys are still filing claims for women who potentially suffered blood clots, DVT and/or Pulmonary Embolism as a result of taking birth control pills containing drospirenone and ethinylestradiol, particularly Yasmin, Yaz and Ocella.
As of late 2013 Bayer has only resolved the non-arterial or venous strokes. Another kind of non-arterial stroke, venous thrombosis, will also be settled, according to Yasmin attorney Jason Brown. The negotiations about arterial events are ongoing.
If you have been injured as a result of Yasmin or Yaz you can still file a case but Bayer will not resolve those cases after its label change of May 2012. Theoretically your injury should have occurred before or on the label change date. However, some attorneys are arguing that if your pills were purchased in a 90-day batch there should be a wider horizon. For instance, if you received pills on May 1, 2012; you should qualify for a claim if your injury occurred at the end of July 2012.
Most gallbladder cases were settled in 2012. If you had counsel as of a certain cut-off date you were entitled to partake in the gallbladder settlement.
The US Food and Drug Administration (FDA) approved Yasmin in 2001 for both birth control and treatment of PMDD (Premenstrual Dysphoric Disorder). Yasmin and Yaz were also marketed and prescribed to treat moderate acne.
Yasmin FDA Approval & Yaz Problems
The miracle drug Yaz was the top-selling birth control pill in the US in 2008 and 2009, as it was marketed to treat women desperate for severe PMS and acne help. But independent studies involving a million women found that Yaz carries higher blood clotting risks than other leading birth control pills, leading to new scrutiny from safety regulators. Bayer denied wrongdoing.
However, Bayer, the maker of the Yasmin contraceptive pill, has been reprimanded on several occasions because of questionable advertising campaigns--the ads were considered misleading in their promise to reduce or cure acne and help with PMS symptoms.
Many womens health advocates are calling for a black-box warning on all fourth-generation contraceptives. The advocacy group Public Citizen has placed all drugs containing drospirenone including Yaz, Yasmin, Gianvi and Zarah on its "do not use" list, stating the birth control pills "can cause increased blood levels of potassium and (are) no more effective than other oral contraceptives in preventing pregnancy.
Bayers Safyral, a new oral contraceptive, was approved by the FDA in December 2010. This birth control pill (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets) is designed to raise folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking Safyral or shortly after discontinuing it.
Safyral, Beyaz, Gianvi, Loryna, Ocella, Syeda, Zarah
Like Yaz and Yasmin (also made by Bayer), Safyral contains drospirenone, known to increase too much potassium in some consumers. And like Yaz and Yasmin, Safyral has been associated with an increase the risk of serious conditions including blood clots, stroke, and heart attack. The risk of blood clots is highest during the first year of use.
Other oral contraceptive brands containing drospirenone include Beyaz and Safyral. Generic versions of Yaz are marketed by Teva (Gianvi) and Sandoz (Loryna). Yasmin generics include Bayer's Ocella, Sandoz's Syeda and Watson Laboratories' Zarah.
Bayer HealthCare Pharmaceuticals has warned that women should not use Safyral if they have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if they have or have had blood clots, certain cancers, history of heart attack or stroke, or if they are or may be pregnant. Safyral increases the risk of serious conditions including blood clots, stroke and heart attack. Smoking increases these risks, especially in women over 35. The risk of blood clots is highest during the first year of use.
A number of studies have reached differing conclusions on the risks of newer birth control pills.
Conflicting Birth Control Studies
One study published in the British Medical Journal October 2011 involving more than 1 million Danish women found that women taking Yaz and other newer medications had twice the risk of blood clots as women taking the older hormone levonorgestrel.
In 2007, however, two studies published as part of the post-marketing requirements of the FDA or European regulators did not find any difference in blood clotting between the two comparable groups. A recent Yasmin FDA-funded study has shown that preliminary results suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives. The FDA said it hasn't reached a final conclusion on the drugs' safety; instead an advisory committee meeting was held, to discuss the risks and benefits of birth control pills that contain drospirenone. Here is the complete FDA study.
In March 2012, The Washington Monthly and the British Medical Journal (BMJ) reported the FDA advisory panel that voted 15-11 to keep Yaz, Yasmin and other drospirenone birth control drugs on the US market may have a conflict of interest. Four of the FDA panel members that voted in favor of keeping the drugs on the market had a connection with Bayer. Consumer advocacy groups, such as the Project on Government Oversight (POGO), are asking the FDA to re-open the issue about Yaz and Yasmin health risks and remove the four members from the panel.
FDA Advisory Panel Conflict of Interest
Yaz, Yasmin and related drospirenone-containing pills were Bayer's second-best-selling franchise in 2010 at $1.6 billion in global sales, according to the Associated Press.
2001: Yasmin birth control is approved by the FDA.
Yasmin and Yaz Time Line
2002: European regulators express concern about link between Yasmin and venous thrombosis after death of 17-year-old. Dutch doctors are advised not to prescribe Yasmin until studies have established its safety.
2003: Maker of Yasmin is warned by the FDA to stop running misleading advertisements regarding Yasmin. The ads allegedly overstate the product's efficacy while understating the health risks.
2006: Yaz birth control is approved by the FDA.
2009: Bayer is forced by the FDA to run ads clearing up alleged misstatements in advertising for Yaz. The FDA alleges that the Yaz ads overstate the drug's ability to cure acne and treat premenstrual syndrome while downplaying the drug's risks. Lawsuits are filed in the US against Bayer alleging Yaz and Yasmin are associated with an increased risk of Yaz and Yasmin blood clots, heart attack and strokes.
2010: Lawsuits are filed in Canada alleging Yasmin and Yaz are associated with an increased risk of heart attack and strokes. On March 10, 2010, aCanada class action is filed against Bayer in Canada. The certification hearing is scheduled to begin Jan. 28, 2013.
September 2011: Yaz bellwether trials get under way. The first Yaz bellwether trial is scheduled to take place September 12, 2011 for pulmonary embolism side effects; that is to be followed by one set for January 9, 2012 and finally a Yaz thromboembolic case on April 2, 2012.
October, 2011: The FDA releases a study of more than 800,000 women taking oral contraceptives which shows that those taking drugs like Yaz had a 75 percent increased risk of developing blood clots.
November 2011: Health Canada announces that a review of drospirenone-containing contraceptives finds 1.5 to 3.0 times the risk of blood clots (Yaz and Yasmin contain drospirenone). The Canadian health agency says that labels have been strengthened to include a warning about the Yaz/Yasmin blood clot risk. The agency further recommends that health care professionals weigh the risks and benefits of certain birth control products that contain drospirenone when determining which contraceptives to prescribe.
December 8, 2011: a joint meeting of the FDA committees ends without recommending to pull Yaz and Yasmin from the market.
The FDA votes 21 to 5 that labeling on Yaz and Yasmin is inadequate and should be updated to include information from several studies that suggest a higher risk of Yaz blood clots. The group votes 15 to 11 that Yaz, Yasmin and other birth control drugs containing drospirenone are still beneficial and should remain on the market. Some health professionals believe that the newer (i.e., fourth) generation of birth control pills, including Yaz and Yasmin, are no more effective than safer alternatives, and therefore, due to the potential risk of Yaz DVT or Yaz blood clots, safer alternatives should be prescribed.
2012: U.S. District Judge David Herndon cancels the Yaz trial that had been set for January 9, 2012 and orders mediation instead. Should mediation in good faith fail, a trial will start on April 30, 2012. In a follow-up clarification, Herndon warns that if Bayer and Yaz/Yasmin plaintiffs do not act in good faith, he will start remanding cases back to the districts where they began.
March 12, 2012: The FDA is asked to reconsider their December 2011 decision concerning the risks of Yaz blood clots versus the benefits of Yaz, Yasmin, Ocella and similar birth control drugs. Bayer settles 70 Yasmin and/or Yaz pulmonary embolism cases.
April 2012: The FDA updates new warning label on drospirenone-containing birth controls including Yaz and Yasmin stating that users may be three times as likely to develop blood clots. Bayer, the manufacturer, says it will not resolve any cases after its label change. The drugmaker agrees to pay at least $110 million to settle 500 lawsuits alleging that Yaz/Yasmin caused fatal blood clots.
August 2012: Bayer settles almost 1,900 lawsuits for $402.6 million, averaging $212,000 per case. The company has doubled its reserve funds for Yaz lawsuits, putting aside $610.5 million for potential settlements. Bayer estimates that the Yaz, Yasmin lawsuits will end up costing $1.2 billion if they continue to settle at this rate, according to Lawyers USA.
September 2012: A study published in Contraception journal finds women who take drospirenone-containing oral contraceptives such as Yaz and Yasmin are 77 percent more likely to develop venous thromboembolic events (VTE) and twice as likely to suffer from arterial thromboembolic events (ATE).
To date Bayer has not admitted liability.
Yasmin, Beyaz and Yaz Birth Control Legal HelpIf you or a loved one has suffered an adverse health event such as a blood clot, from using these products, please click the link below and your complaint will be sent to a Yasmin lawyer who may evaluate your claim at no cost or obligation.
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