FDA To Hold Meeting on December 8, 2011 About Safety of Yaz and Yasmin

On December 8, 2011, the FDA is holding a meeting of the Reproductive Health Drugs Advisory Committee and the Drug and Safety Risk Management Committee to discuss the risk of blood clots in drugs such as Yaz and Yasmin that contain drospirenone. This is on the heels of the release of the FDA’s study showing that birth control like Yaz and Yasmin containing drospirenone is 74% more likely to cause blood clots than low-estrogen pills. Another study this week published in BMJ found that birth control containing drospirenone were six times more likely to cause venus thromboembolism, which are life-threatening blood clots that start in the leg and travel to the lungs. Lawsuits are pending against Bayer in federal court and state courts around the country. The lawyers handling Yaz and Yasmin lawsuits have uncovered documents such as case studies and clinical trials that may assist the FDA in the meeting on December 8, 2011. The plaintiffs’ lawyers have also uncovered documents that may reflect a conflict of interest among some of the FDA panel members. Presently, these documents are confidential because they were produced on a confidential basis to the lawyers that represent the victims in the Yaz and Yasmin lawsuits. The plaintiff lawyers are seeking permission from the federal court to produce these documents to the FDA in advance of the hearing. The lawyers at the Levensten Law Firm believe that the federal court will order that many of these Yaz and Yasmin documents must be produced to the FDA in the interest of public safety. We further believe that following the hearing, birth control such as Yaz and Yasmin will be required to carry stronger warnings, or could be subject to a voluntary Yaz and Yasmin recall.

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