FDA Panel Recommends Stronger Warning for Yaz and Yasmin

December 12, 2011
By JONES WARD PLC on December 12, 2011 5:13 PM |

A U.S. Food and Drug Administration advisory committee recommended stronger warning labels for Bayer's birth control pills Yaz and Yasmin. By a 21 to 5 vote, the panel recommended changing the contraceptives' labels to reflect the possibility that the pills could lead to a higher risk for blood clots or deep vein thrombosis (DVT). Currently, the labels suggest the risk of blood clot is similar to those of other contraceptives that combine estrogens and progestins.

FDA spokeswoman Morgan Liscinsky said the panel acknowledged the conflicting data but "definitely felt that stronger labels were needed, that the labels need to be updated to reflect current data." While some physicians do not believe this risk is enough to change their prescribing habits, others, including members of the FDA advisory committee, disagree. In an interview with the Wall Street Journal, committee member Sean Hennessy of the University of Pennsylvania stated physicians should use an abundance of caution because "these drugs ought to be rarely used."

A deep vein thrombosis (DVT) is a serious condition where a blood clot forms inside a vein. DVTs are very serious and can be deadly. These clots typically form in the lower leg or thigh, but can travel to other areas of the body. A pulmonary embolism (PE) is a potentially fatal condition where the clot breaks loose and travels to the lung blocking a lung artery. DVTs and PEs are also known as venous thromboembolic events, or VTEs. DVT symptoms include the new onset of persistent leg pain. The symptoms of a PE include sudden shortness of breath and severe chest pain. VTEs can be life threatening and women experiencing these symptoms should seek immediate medical care.

The attorneys at Jones Ward PLC represent women from across the country that have been harmed by Yaz, Yasmin and Ocella. If you would like to speak with someone about a potential case, please call the attorneys at Jones Ward PLC at 1-888-KYLAW22 (595-2922) or email tj@jonesward.com.