FDA Finds Yaz Contains Insufficient Warning Lables

On Thursday, the Food and Drug Administration (FDA) voted 21 to 5 that the label on Yaz and its predecessor Yasemin birth control does not adequately warn users about the drug’s risk of causing blood clots, which is higher than other oral contraceptives. In addition, the FDA found that Yaz and Yasemin did not contain sufficient warnings about the increased risks for patients who are overweight or who smoke.

According to a recent FDA study, women who took Yasemin were 75 percent more likely to suffer a blood clot than patients taking other forms of birth control, which do not contain the hormone drospirenone. Dr. Richard Bockman, a physician at New York’s Hospital for Special Surgery, stated, “Clearly the wording is inadequate and incomplete. Adverse events have to be made graphic so physicians and patients are aware of the consequences.”

Currently between 4,000 and 6,000 plaintiffs are suing Bayer, the maker of Yaz and Yasemin, in a personal injury lawsuit. Yaz was approved in 2006 and became the most commonly sold birth control pill in the United States in 2008. Since then, sales of the drug has decreased by approximately 80 percent as a result of safety concerns.

Associated Press 12/9/11; Huffington Post 12/8/11

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