Recent research has found that the birth control may increase a woman’s risk of developing a blood clot by more than 74%.
In light of this research, and other studies that corroborate this finding, the panel voted 21-5 that the safety warnings on the medications are inadequate and must be changed to include explicit new warnings about the heightened risk of developing a blood clot that can lead to death.
In October, the FDA announced the results of its own study of the pills, which contain drospirenone. After following more than 800,000 women since the drugs became available in the U.S., the study found that the pills increased a woman’s risk of several serious, life-threatening side effects, including: deep vein thrombosis (DVT), pulmonary embolism, heart attack, stroke, and death.
Yaz, Yasmin and other new birth control pills belong to a new class of medications that contains drospirenone, a new type of synthetic progestin. Other oral birth control medications containing drospirenone include Yaz, Yasmin, Ocella, Beyaz, Zarah, Loryna, Gianvi, Syeda, and Safyral.
The FDA committee deliberated on the subject for more than nine hours. They discussed the quality of the information, and while they found some issues with the research, they overwhelmingly agreed that the research has found an increased risk of developing a blood clot. Furthermore, the safety labeling on the pills is not explicit enough to warn women effectively — blood clots can lead to death.
However, it seems unlikely that the drugs will be taken off the market. The committee also voted 15-11 that the oral contraceptives remain a beneficial and effective way to prevent pregnancy. When taken as directed, fewer than 1 woman out of 100 will become pregnant — no different from older, low-estrogen contraceptives. The committee-members who voted against this measure stated that because the drugs are no more effective at preventing pregnancy, but carry catastrophic side effects including death, the risks outweigh the benefits of preventing pregnancy.
Bayer AG, the manufacturer of Yaz and Yasmin, may be litigating up to 10,000 lawsuits brought against the company by women who experienced a serious side-effect after using the contraceptives. Many of these women chose Yaz and Yasmin over older, low-estrogen types of birth control because they believed the new drugs were safer, had off-label benefits such as the reduction of acne and the relief of PMS symptoms.
The FDA sent Bayer’s marketing team a warning letter after finding that the TV advertisements failed to mention any risk information and were misleading to consumers. Warning letters were sent in 2003, 2009, and 2009, indicating that problems with misleading advertising was an ongoing issue. Bayer eventually spent $30 million on corrective advertising to warn consumers of the risks — shortly thereafter, sales dropped more than 50%. Yaz, approved in 2006, was the best-selling contraceptive in the U.S. by 2008.
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