In August, the FDA sent a warning letter to Bayer Pharmaceuticals about problems in their German plant where an important active ingredient for Yaz and Yasmin birth control pills is made. FDA officials had previously inspected that plant and on finding violations of good manufacturing practices, had sent a letter to Bayer asking for various corrections.
The August letter notes that some of those have now been completed, or are planned for upcoming implementation, but that Bayer’s written response to the FDA of April this year did not properly address some of the issues.
Hidden Testing Data?
The FDA claims that Bayer had concealed some data by using improper averaging in their compilations. When some batches of the drug were tested, they deviated from the company’s specifications, but instead of reporting that, Bayer included those batch results in with other test results and averaged the whole lot together.
Meanwhile, the deficient batches of Yaz and Yasmin were released for distribution. Bayer’s letter to the FDA stated that it is proper to include bad batches in with good batches when averaging out the test results.
However, the FDA is concerned about the bad batches that were released for sale in the U.S. FDA officials have asked Bayer to submit a list of all the active ingredients in the batches sent to the U.S. that had tested poorly. This can be seen as a precursor to a recall of those Yaz and Yasmin batches.
Health Problems Associated with Yaz and Yasmin
Yaz is a newer birth control pill than Yasmin, having received FDA approval in 2006. It has been marketed vigorously but many reports have been made that connect it with:
- Gallbladder disease
- Heart attack
- Pulmonary embolism
- Deep vein thrombosis
The Yaz ingredient in question is called Drospirenone. It is also in Yasmin but not in older birth control pills. It is a progestin that inhibits development of the uterus lining that would accompany pregnancy.
If you or someone you love has taken Yaz or Yasmin and experienced any disturbing health problems, please contact a physician. You might also want to consult a defective drug attorney.
Our personal injury law firm serves Mobile, Alabama, and we will be happy to give you a free case evaluation if you send us an email.