Yasmin/Yaz Manufacturer Warned by FDA

The U.S. Food and Drug Administration (FDA) has warned the makers of Yasmin and Yaz birth control drugs about problems concerning the testing and quality of the pharmaceutical ingredients in the drugs.  This, after repeated warnings by the federal government to Bayer (and its predecessor Berlex) for improperly marketing its birth control drugs in a manner that overstates the drugs’ benefits and downplays the very serious, and potentially fatal, side effects of the drug.

In a letter released on September 15, 2009, the FDA warned Bayer about the quality control and testing problems relating to the key ingredient in Yasmin and Yaz, drospirenone.  Click here to view the letter.

The warning followed an inspection, conducted in March, of the Yasmin manufacturing plant in Berghamen, Germany that “revealed significant deviations from U.S. current good manufacturing practices (CGMP) in the manufacture of non-sterile APIs [Active Pharmaceutical Ingredients].”  Bayer has thirty days to respond to the warning.

Andrus Anderson LLP is representing women who have been harmed by Yasmin and Yaz, including those who have suffered: gall bladder disease, heart attack, stroke, cardiac arrhythmias, pulmonary embolism (PE), deep vein thrombosis (DVT), liver failure and kidney failure.  The primary concern with Yasmin and Yaz is that the active ingredient, drospirenone, increases potassium in the blood to dangerous levels.  A prominent consumer advocacy group, Public Citizen, listed Yasmin as a “Do Not Use” drug in 2002, because:

*Yasmin side effects caused by drospirenone increase blood levels of potassium, which could result in heart problems and other health concerns; and

* There is no evidence that the drug is superior to old contraceptives or that the benefits outweigh the risk of Yasmin dangers.

For more information on the potential dangers of Yasmin and Yaz, or to speak to an attorney, please contact Andrus Anderson LLP by clicking here.