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FDA Issues Warning Letter to Manufacturer of Yaz and Yasmin

On September 15, 2009, the FDA published a warning letter to Bayer Healthcare and Bayer Schering Pharma AG, listing significant deviations found by FDA inspectors during a routine inspection of Bayer’s Bergkamen, Germany plant. The FDA cited Bayer, manufacturer of Yaz and Yasmin birth control pills, for conflicting with the standard United States current good manufacturing practices (CGMP). Specifically, inspectors considered Bayer’s laboratory controls to be deficient. The letter also explained how Bayer’s quality management system failed to ensure that the drugs Bayer manufactured and released met the FDA’s specifications. The FDA’s list of these failing drugs included Drospirenone and Ethinyl Estradiol, the two major components of both Yaz and Yasmin.

The Public Citizen, in its “Worst Pills, Best Pills” list, labeled the combination of drospirenone and ethinyl estradiolas a “Do Not Use” drug because “it can cause increased blood levels of potassium and is no more effective than other oral contraceptives in preventing pregnancy.”

The FDA has asked Bayer to provide a full list of all shipments to the U.S. that may have been subject to deficient methods, and also to provide a plan to prevent this problem from recurring. Meanwhile, Bayer has not advised healthcare providers to stop prescribing Yaz and Yasmin, nor has it suggested that patients might consider ceasing the use of Yaz and Yasmin.

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