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FDA Panel Votes to Update Safety Information for Yaz, Yasmin Birth Control Pills


November 8, 2011 — An FDA panel met today to discuss requiring stronger safety labeling on Yaz, Yasmin, and other popular birth control pills. Today, the panel voted 21-5 that the safety labeling is inadequate and should be updated to include the findings of several recent studies.

The most recent study is one conducted by the FDA, which tracked more than 800,000 women. The study linked Yaz and Yasmin to a higher risk of developing blood clots — a woman may be 74% more likely to develop a blood clot while taking this type of birth control, compared with older, low-estrogen contraceptives.

The panel spent more than nine hours deliberating, and though they disagreed on the quality of the evidence, the overwhelming majority agreed that the labels should explicitly warn consumers of the increased risk of developing a blood clot — and furthermore, state that blood clots can lead to death.

At least 50 women have died as a direct result of taking the newer forms of birth control. Thousands more have suffered complications of blood clots, including deep vein thrombosis (DVT), heart attack, stroke, and pulmonary embolism. Bayer AG, the manufacturer of Yaz and Yasmin, is facing nearly 10,000 lawsuits from women who have been injured by the medications.

The panel also voted 15-11 that the pills remain a beneficial option for preventing pregnancy. This vote indicates that the FDA will likely continue to allow the drugs to stay on the market. The dissenting opinions were based on the fact that these types of birth control pills are no more effective than older, low-estrogen birth control pills, but have significantly catastrophic side effects. Women with no history of thromboembolic events have died as a direct result of taking these birth control pills.


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