Last month, the FDA issued a warning letter to Bayer, the pharmaceutical company that manufactures the birth control pills Yaz and Yasmin, detailing several problems at a plant in Germany which produces drospirenone, one of the active ingredients in these products. The FDA released the letter to the general public on their website last week.
The accusations against Bayer indicate that the company has not adhered to good manufacturing practices which should have prevented the shipment of several batches of the product to the United States. The letter alleges that Bayer hid the results of several tests which indicated some batches of the drug did not meet company specifications.
According to the FDA, Bayer took out-of-specification (OOS) test results and mixed them in with good test results, reporting the average of the two groups instead of reporting the instances where a batch did not meet proper quality standards. As a result, Bayer was able to release OOS batches to the general public that should have never reached the United States.
The FDA has ordered Bayer to produce a list of all active ingredient batches shipped to the United States that contained OOS test results in preparation for a potential Yaz and Yasmin recall. The pharmaceutical company has also been ordered to generate a plan to bring its manufacturing practices up to standards dictated by the FDA.
This is not the first time problems have been reported with Yaz and Yasmin. Bayer currently faces more than 50 defective drug lawsuits related to these birth control products which claim the pharmaceutical company failed to properly warn consumers about side effects that may result in:
- Heart attacks
- Stroke
- Deep vein thrombosis
- Pulmonary embolism
- Gallbladder disease
- Death
It is expected that many more pharmaceutical injury lawsuits will be filed in the near future. If you have developed a serious illness or injury from taking Yaz or Yasmin, an experienced defective drug lawyer can help you receive the compensation you deserve.
If you have a Yaz or Yasmin claim in the Norfolk, Virginia area, please contact the Virginia pharmaceutical injury lawyers at Kalfus & Nachman today to schedule your complimentary initial consultation.
