Timeline: Yasmin, Yaz (dropsirenone and ethinyl estradiol)


timeline yaz yasmin2001: The U.S. Food and Drug Administration (FDA) approves Bayer AG’s Yasmin as an oral contraceptive. Like traditional birth control pills, Yasmin’s regimen involves 21 days of active pills and 7 days of inactive, or placebo pills.

Mar. 2006: The FDA approves Yaz as an oral contraceptive. It is the first dropsirenone-containing pill to implement an active 24 day regimen. At this time, it is thought that this method of birth control would result in less hormonal fluctuation.

Oct. 5, 2006: The FDA approves Yaz to treat premenstrual dysphoric disorder (PMDD), a condition with symptoms similar to premenstrual syndrome (PMS), but more severe. Contrary to popular belief at the time, Yaz is not approved to treat PMS.

Jan. 2007: The FDA approves Yaz for treatment of moderate acne.

Oct. 3, 2008: The FDA issues a warning letter to Reinhard Franzen, President and Chief Executive officer of Bayer Healthcare Pharmaceuticals. The letter states that in its Yaz advertisements, the company fails to warn viewers of the risks and overstates the efficacy of the drug. In particular, one of the ads seems to imply that Yaz is effective in treating PMS, a condition that has not been FDA approved. Bayer is also accused of overstating the drug’s effects on acne; commercials imply that Yaz can treat all stages of acne, while clinical studies have only shown its effects on moderate acne. Furthermore, the commercials distract viewers with visual images, impairing the viewer’s ability to properly note the serious side effects of the pill. Overall, the FDA letter states that the ads are misleading and that Bayer has committed a series of violations under the Federal Food, Drug and Cosmetic Act; it requests that the manufacturer make corrective efforts in its advertisements.

Feb. 2009: Bayer introduces a $20 million corrective campaign in compliance to the FDA’s letter. The ads are to clarify the difference between PMS and PMDD, and well as its affects on acne.

Oct. 1, 2009: The U.S. Judicial Panel on Multidistrict Litigation moves to consolidate all Yaz and Yasmin lawsuits concerning death and personal injury. The MDL is set to be centralized in front of US District Court Judge David Herndon in the Southern District of Illinois.

Apr. 2010: The FDA updates Yaz’s safety label to address its possible impact regarding thromboembolic disorders and vascular problems.

Mar. 2011: The FDA approves a Yaz label change addressing the increased risk of venous thromboembolism (VTE) during the patient’s first year of taking the drug. The change addresses all combined oral contraceptives (COC).

Dec. 2011: Former FDA commissioner David Kessler issues a report stating that Bayer purposely omitted safety data concerning the risk of blood clots associated with Yaz and Yasmin. In his report, Kessler states that “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from pre-marketing to the present.”

Dec. 2011: An FDA advisory panel votes 21 to 5 in favor of a label change on Yaz, Yasmin, Beyaz, Sefyral and its generic equivalents. The panel decides that the current labels, which only cite ambiguous research findings, do not adequately warn women about the potentially fatal blood clot risk. No deadline is set for the label change.

Jan. 2012:
US District Court Judge David Herndon postpones the first Yaz, Yasmin trial, and appoints George Washington University law professor Stephen Saltzburg as a mediator in the meantime.

Feb. 2012: The safety label on Yasmin, Safyral and Beyaz is updated to include the increased risk of VTE during the first year of use; this is the same modification applied to Yaz in March 2011.

Feb. 2012: Current Drug Safety journal publishes a study linking oral contraceptives containing drospirenone to irritable bowel syndrome (IBS). This association was not seen with other types of birth control pills.

Feb. 1, 2012: As of this day, Bayer faces approximately 11,300 product liability claims, according to the company’s 2011 annual report.

Feb. 13, 2012: Bayer chooses to settle 70 lawsuits alleging that Yaz, Yasmin or its generics caused injury and death.

Apr. 10, 2012: The FDA updates labels on Yaz, Yasmin and other drospirenone-containing birth controls. The new warning states that users may be three times as likely to develop blood clots.

Apr. 13, 2012: Bayer agrees to pay at least $110 million to settle 500 lawsuits alleging that Yaz/Yasmin caused fatal blood clots.

Aug. 2012: Bayer has settled nearly 1,900 lawsuits for $402.6 million, an average of $212,000 per case. The company has doubled its reserve funds for Yaz lawsuits, putting aside $610.5 million for potential settlements. According to Lawyers USA, Bayer estimates that the Yaz, Yasmin lawsuits will end up costing $1.2 billion if they continue to settle at this rate.

Sept. 2012: Contraception journal publishes a study showing that 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).