FDA Sends Warning Letter to Makers of Yaz – Yasmin

As if the makers of Yasmin / Yaz didn’t have enough to worry about with pending lawsuits related to major side-effects, now they’ve been served a warning letter from the FDA for quality control problems at a plant in Germany that manufactures one of the ingredients in the drug. FDA inspectors discovered the problems during an inspection in March, 2009, and informed Bayer. Bayer claims that the quality of the drug was not affected.

Unacceptable Testing Method
According to the FDA warning letter, Bayer used a testing method that averaged the test results rather than reporting the test results for individual batches. The average was within specified parameters, but individual batches were out-of-specification (OOS), and according to the FDA letter should not have been released. At least eight batches that were tested with this method were shipped to the U.S.

After the March inspection, Bayer reviewed the batches it had shipped to the U.S. between 2007 and 2009. They responded to the FDA in April, 2009, claiming that there was no problem with the quality and an explanation of why it believes this. This recent letter from the FDA states that Bayer’s “response does not adequately address some of the deficiencies.”

Bayer is now required to give the FDA a list of all the batches shipped to the U.S. that may have been tested with the unacceptable method. The FDA may also delay imports from the plant.

Yasmin / Yaz Plagued with Problems
This is just the latest problem Bayer has faced with Yaz / Yasmin birth control medications. Life threatening side effects have already prompted multiple lawsuits against the drug maker. Yasmin is a birth control pill that uses a combination of the hormones drospirenone and ethinyl estradiol to prevent pregnancy. Drospirenone can cause elevated potassium levels leading to heart problems and other health problems.

Yaz/Yasmin side effects may include deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, cardiac arhythmias, gallbladder disease, and sudden death. The generic version of Yasmin is called Ocella, and carries the same risks.

One of the biggest reported risks of Yaz/Yasmin is the development of blood clots, leading to stroke or heart attack in women who were healthy before taking the drug and were not at risk for either life threatening event. DVT is blood clot in the legs. PE is blood clot in the lungs. In young, healthy women these blood clots are often overlooked or misdiagnosed, leaving them in grave danger.

Even when the clots are discovered and treated the effects can be long-term and can mean a lifetime of taking medications to prevent more clots from forming.

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