FDA Issues Warning Letter over Problems at Yaz and Yasmin Plant



A warning letter issued to Bayer Pharmaceuticals last month has just been released on the FDA website for public viewing. The letter points out serious problems with a plant in Germany used for the manufacture of their birth control products Yaz and Yasmin, and it criticizes the pharmaceutical company for the way they have handled these problems.

According to the FDA warning letter, Bayer has failed to take the proper steps to ensure the safety of these birth control pills, allowing several batches of drugs to be shipped to the United States despite data indicating that they were unfit for sale. Furthermore, Bayer attempted to hide this information in an attempt to sell the defective batches.

FDA inspectors reviewing the plant in Germany found that several batches of the drugs contained out-of-specification (OOS) results for the testing of active ingredients. Instead of pulling these batches, Bayer diluted the test results by averaging these results with those of good batches in order to ensure that data would show that the overall supply met proper FDA specifications. As a result, the OOS batches were shipped to the United States for distribution.

The FDA has ordered Bayer to submit a list of all active ingredient batches shipped to the United States containing OOS test results. This step will most likely lead to a partial Yaz and Yasmin recall in the near future. Bayer must also alter their practices to meet standards established by the FDA.

There have already been numerous reports of serious side effects associated with Yaz and Yasmin, and there are currently over 50 pharmaceutical injury lawsuits against Bayer alleging that the company failed to adequately warn consumers of these side effects, which have led to:

  • Heart attacks
  • Stroke
  • Deep vein thrombosis
  • Pulmonary embolism
  • Gallbladder disease
  • Death

It is expected that there will be more than 1,000 Yaz and Yasmin lawsuits filed within the next year. If you currently use either of these products, you should talk to your doctor about alternative birth control products which may be safer. If you have suffered an injury from taking Yaz or Yasmin, you should consult an experienced defective drug lawyer immediately to find out how best to proceed with your claim.