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Limited Yaz Recall
In November 2009, the FDA quietly issued a recall for over 32,000 boxes of Yaz, as well as more than 122,000 boxes of Ocella, the drug’s generic version. Bayer, the drug’s manufacturer, had taken out-of-specification values for levels of drospirenone and ethinyl estradiol and averaged them with other values in order to yield results that were within spec. 1
The recall was not widely reported at the time, even on the FDA’s own website. Reportedly, the FDA had previously warned Bayer about its averaging practice. 2
FDA Review of Yaz
In May 2011, the FDA informed the public of new information regarding risks specific to woman taking birth control pills containing drospirenone, including Yaz. The report of their findings, in which the FDA expressed concern over the increased risk of venous thromboembolism events (blood clots) in affected drugs, was released later that October. Ultimately, the FDA decided to allow Yaz to remain on the market.
Blood Clot and Gallbladder Lawsuits
As of July 2012, more than 12,000 lawsuits have been filed against Bayer over alleged Yaz-related blood clots and gallbladder damage. Lawyers for the plaintiffs claim that Bayer misled consumers about the risks and benefits of using the drug.
FDA Black Box Warning
Yaz carries a black box warning detailing the risk of cardiovascular events when used by smokers. The label advises women over 35 who smoke not to take the drug.
In 2012, after completing a review of 6 epidemiological studies, the FDA updated the Yaz label to warn patients of the elevated risk of blood clots in women taking the pill. The studies varied in their conclusions, with some finding no elevated risk, while others found that risk increased as much as 3 times compared to patients taking other kinds of birth control pills. The label recommends that patients stop Yaz for 4 weeks before and 2 weeks after undergoing surgery, and when a thrombotic event (blood clot) occurs.
The label also warns of hyperkalemia, an electrolyte imbalance that can lead to heart arrhythmia, and gallbladder disease.
Bayer and False Advertising
In early 2009, the FDA took the unusual step of ordering Bayer to release a series of ads correcting false claims made in prior Yaz advertisements. The earlier ads had implied that Yaz would help fight acne and premenstrual syndrome. Bayer spent over $20 million on a TV ad campaign that directly addressed the claims, as well as a print campaign that provided new information without explicitly calling out the offending ads. The company was also required to submit all Yaz ads for FDA approval for a period of six years. 3
U.S. Food & Drug Administration. “Enforcement Report for September 25, 2009.” (Sept. 25, 2009) FDA.gov. Accessed Oct. 22, 2014. ↩
Edwards, Jim. “Did You Know the FDA Recalled Bayer’s Yaz Contraceptive? Neither Did Anyone Else.” (May 6, 2010) Moneywatch. Accessed Oct. 22, 2014. ↩
Singer, Natasha. “A Birth Control Pill That Promised Too Much.” (Feb. 10, 2009) The New York Times. Accessed Oct. 22, 2014. ↩