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FDA Panel Cites Clot Risk From Contraceptive Patch
Date:12/12/2011

. Both contain a newer type of man-made progestin hormone called drospirenone, which could increase the chances of dangerous clots in the legs or lungs, compared to older forms of oral contraceptives. The newer contraceptives have been successfully marketed on the premise that they have fewer of the unwanted side effects of older hormone pills such as bloating, mood swings and acne.

Speaking ahead of the decision, Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York City, said that the risk of clotting with the newer pills is "a low risk but the risk exists. The idea of the FDA looking at this and potentially increasing the warning has no downside. If anything, it increases awareness and that can only be a good thing."

Earlier Thursday, the panel members voted 15 to 11 that the newer contraceptives, which gained initial FDA approval in 2001, are a viable method of birth control, and that the benefits of preventing pregnancy outweigh the health risks.

While the FDA isn't obligated to follow the recommendations of its advisory panels, it usually does so.

More information

The U.S. Department of Health and Human Services has more about birth control at womenshealth.gov.

SOURCES: Tara Narula, M.D., cardiologist, Lenox Hill Hospital, New York City; Associated Press


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