FDA Warns Bayer About Yaz

The maker of Yaz/Yasmin birth control , Bayer AG, has received a warning letter from the Food and Drug Administration (FDA), regarding the quality of drug ingredients of the oral contraceptive found during the testing process.

Dated August 5th, 2009, the letter follows an FDA inspection in March of a manufacturing plant in Germany. The letter reveals that Bayer used a testing method that averaged the results for the amount of one of the ingredients used to make Yaz/Yasmin. While the average was within specified parameters, some individual batches were revealed to be "out of specification" or OOS. According to the FDA, these batches should not have been released. Worse, 8 of those batches were shipped to the US.

According to a report by Reuters, the FDA letter stated, "We remain concerned with your released and distributed API batches used in the manufacture of finished products intended for the U.S. market." The letter reportedly went on to state that some of Bayer's "laboratory controls are deficient."

The adverse events associated with Yaz and Yasmin birth control pills include deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, cardiac arhythmias, gallbladder disease, and sudden death. The generic version of Yasmin, Ocella, carries the same risks.

FDA Warns Bayer About Yaz

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