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Yaz, Yasmin, Ocella Litigation Consolidated in Pennsylvania
On September 16, Judge Sandra Mazer Moss of the Philadelphia Court of Common Pleas consolidated all of the lawsuits filed in Philadelphia that involve Bayer’s popular prescription contraceptives: Yaz and Yasmin. Ocella, the generic equivalent of Yasmin, is manufactured by Barr Laboratories.
Recent reports suggest that these prescription medications could be putting millions of young women at risk of serious side effects, including stroke, heart attack, blood clots, deep vein thrombosis, pulmonary embolism, and even death. A recent study published by the British Medical Journal demonstrated that birth control products containing the active ingredient contained in Yaz, Yasmin, and Ocella—drospirenone—carried a risk of blood clots nearly double that of other birth control medications. Other reports have associated drospirenone with an increased risk of gall bladder disease, resulting in removal.
On September 14, the Food & Drug Administration released a warning to Bayer about problems found in a March 2009 inspection in the Berghamen, Germany plant where Bayer manufactures the Yaz and Yasmin birth control pills that it sells in the United States. The warning said the inspection “revealed significant deviations from U.S. current good manufacturing practices (CGMP) in the manufacture of non-sterile APIs [active pharmaceutical ingredients].”
Bayer has previously received warnings from the FDA for advertisements that overstated the benefits of Yaz and which minimized the potential safety risks associated with the drug. As a part of a subsequent agreement with the FDA and attorneys general in 27 states, Bayer began running a new ad campaign in February 2009 to correct the information conveyed by deceptive Yaz commercials.
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