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FDA Advisers: Newer Forms of the 'Pill' Need Revised Warning Labels
Date:12/10/2011

By Steven Reinberg
HealthDay Reporter

THURSDAY, Dec. 8 (HealthDay News) -- U.S. health advisers recommended Thursday that several newer forms of oral contraceptives carry revised labels warning about an increased risk of potentially fatal blood clots.

The U.S. Food and Drug Administration advisers voted 21-5 in favor of the new labels for oral contraceptives such as Bayer's Yaz or Yasmin. 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.

"Clearly, the wording is inadequate and incomplete," said Dr. Richard Bockman, of New York's Hospital for Special Surgery, the Associated Press reported. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

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.

Several doctors said in advance of the hearing that the potential increased risk of clots is not great, but should not be dismissed, either.

"It's a low risk but the risk exists," said Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York City. "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."

Women who smoke or have a history of blood clots should not be taking oral contraceptives, she said.

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