FDA panel supports birth control Yaz but advises labeling changes

By Dr. Ananya Mandal, MDDec 11 2011

Medical experts at the panel of Food and Drug Administration have voted 15-11 that Bayer's Yaz, and Yasmin and similar medications used as birth control pills remain a beneficial option for women, despite an increasing number of studies suggesting the drugs are more likely to cause dangerous blood clots than older birth control pills.

The FDA convened the panel to consider additional safety measures for newer contraceptives based on recent studies that show a slightly higher risk of blood clots with the drugs. Evidence from all studies since the Yasmin was first approved in 2001 presents conflicting data about the riskiness of drospirenone but concerns have been mounting in recent years that Bayer's pills could lead to possibly fatal blood clots.

The panel is now scheduled to discuss adding new warning information to the drugs' labeling about the potential risks of blood clots. Experts have recommended a revision of labels for the pills. Outside experts advising the Food and Drug Administration on Thursday voted 21-5 that current label inadequately reflected the risks and benefits of a newer generation of pills that contain the compound drospirenone, including Bayer AG's popular Yaz and Yasmin.

Former FDA Commissioner Dr. David A. Kessler, now working for lawyers suing Bayer, accuses the drug maker of concealing the contraceptive's health risks. “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to [blood clotting] events,” Kessler said in court documents, citing studies that Bayer itself conducted but allegedly misreported to regulators. He indicated that if he had been head of the FDA in 2000 and knew what he knows now, he may not have approved the drug. “In my opinion, had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted,” he wrote.

Bayer maintains that Yaz is safe. “Based on a thorough assessment of the available scientific data, Bayer believes that its drospirenone-containing products are safe and effective and have a favorable benefit-risk profile when used in accordance with U.S. product labeling,” Bayer spokeswoman Rose Talarico told ABC News.