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FDA Panels to Weigh Safety of Newer Forms of the 'Pill'
Date:12/7/2011

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Dec. 7 (HealthDay News) -- Two U.S. Food and Drug Administration advisory panels will meet Thursday to discuss whether to recommend new warning labels about increased risk of blood clots with newer forms of oral contraceptives.

The Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will hear from experts and the public, and then make a recommendation to the full FDA. The agency typically follows the advice of its advisory panels.

The concern among health officials is that oral contraceptives such as Bayer's Yaz or Yasmin contain a newer type of progestin hormone called drospirenone, which may carry a higher risk of dangerous clots in the legs or lungs than 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. FDA officials are also looking at whether those clotting risks are higher with Johnson & Johnson's weekly Ortho Evra patch, which uses a different version of the female hormone progestin than the pills under scrutiny.

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.

Narula added that women considering an oral contraceptive might want one of the older ones. "If you are going to take a risk at least have it be as low as possible. And if that means taking
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