Food and Drug Administration experts agree that drug labeling for Yaz and other birth control pills should better warn consumers of potentially dangerous side effects.
Yaz was approved by the FDA in 2006 and was the subject of an advertising campaign that emphasized the drug's ability to clear up acne. By 2008, Yaz was the best selling birth control prescription drug in the United States.
Women who take birth control pills containing drospirenone -- an active ingredient in Yaz -- have a higher risk of developing blood clots that can potentially be fatal. Blood clots can cause heart attacks, strokes and blockages in the circulatory system. Women taking Yaz have a 75 percent higher chance of developing a blood clot; however, the absolute risk of a clot is still less than a fraction of one percent. Still, more than a half-dozen patients or family members have blamed Yaz for blood clots.
FDA panelists who made the recommendation said that the drug labeling should also call out the fact that overweight patients and patients who smoke cigarettes are at higher risk of developing blood clots.
Thousands of women who took Yaz are plaintiffs in personal injury lawsuits against Bayer, the manufacturer of Yaz and its predecessor, Yasmin. Bayer marketed both drugs with an advertising campaign that critics say overemphasized the drugs' ability to counteract the side effects of older oral contraceptives -- symptoms such as moodiness, bloating and acne.
In the meantime, doctors say that the risk of blood clots associated with pregnancy and childbirth is still far higher than the risk associated with birth control pills.
Source: Associated Press, "FDA panel wants more risk information on Yaz pills" Matthew Perrone, Dec. 8, 2011
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