Criticism Of Popular Oral Contraceptive Yaz Could Harm Product's Appeal, New York Times Reports

The popular oral contraceptives Yaz and Yasmin have been tainted recently by safety concerns raised by researchers, health advocates and lawyers for plaintiffs who have filed lawsuits against manufacturer Bayer Healthcare, the New York Times reports. These groups argue that the drugs put women at higher risk for strokes, blood clots and other health problems than some other oral contraceptives. Citing warning letters FDA sent to the company, plaintiffs' attorneys contend that Bayer was aware or should have been aware of the problems. These new concerns could "rattle consumer confidence" and harm the drugs' image as the "go-to brands for women under 35," according to some industry analysts, the Times reports. In 2001, FDA approved Yasmin, which contains drospirenone, a progestin that can increase the body's potassium levels. According to the drug's label, the potassium increase may put women with liver and kidney problems at higher risk for serious health problems. Yaz, which also contains drospirenone and a lower dose of estrogen, was approved in 2006 as both a contraceptive and a treatment for premenstrual dysphoric disorder and moderate acne. The drugs' popularity is due in part to multimillion-dollar advertising campaigns, and together Yasmin and Yaz brought in about $1.8 billion in worldwide sales in 2008 for Bayer.

FDA in October 2008 sent Bayer a warning letter for running two false and misleading TV ads about Yaz. FDA said the ads overstated Yaz's efficacy, promoted it for conditions -- like premenstrual syndrome -- for which it is not approved, and downplayed serious risks associated with the drug. Bayer agreed in February 2009 to spend $20 million on a corrective ad campaign to address the misimpressions from the original campaign.

FDA sent another warning letter to Bayer in August 2009, this time regarding deviations from quality control standards at a manufacturing plant in Germany that makes drospirenone and other hormone ingredients used in the pills sold in the U.S. The letter said methods used by the facility to calculate variability in ingredients did not meet U.S. standards.

According to Bayer, the company has been served with 74 lawsuits brought by women who say they developed health problems after taking Yasmin or Yaz. According to the Times, because the drugs' labels warn of the risk of blood clots and stroke, the plaintiffs could have difficulty winning on the argument that Bayer should have issued stronger warnings. The plaintiffs might be more likely to prevail if lawyers are permitted to use the FDA warning letters to argue that misleading advertisements enticed women to take the pills, exposing them to health risks that they might not have otherwise encountered, the Times reports. Michael Santoro, an associate professor at Rutgers Business School who has studied ethics in the drug industry, said past warnings from FDA about advertising and quality control raise questions about Bayer's approach to complying with government guidelines.

An FDA spokesperson said the agency is reviewing the safety of oral contraceptives through a study designed to identify the incidence of blood clots, stroke and death among users of Yasmin and other oral contraceptives. Meanwhile, officials with Bayer said the company plans to vigorously defend itself against the lawsuits. Bayer also is conducting a postmarket study comparing Yaz's safety with that of other oral contraceptives (Singer, New York Times, 9/26).

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