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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.

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 one of the older generation drugs, that may be better for you than taking some of the newer ones even though they're highly marketed and promoted," she said.

Dr. Christopher Estes, an assistant professor of obstetrics and gynecology at the University of Miami School of Medicine, said "the data that exists regarding the risks of these pills needs to be taken with a grain of salt. We have known forever that contraceptive pills that contain estrogen and progesterone all elevate the risk of blood clots, heart attack and stroke. The amount that it [newer contraceptives] raises the risk is small, and over an entire population the increase in risk is not very great."

Some women, especially those at risk for blood clots, heart attack or stroke, should probably not use any oral contraceptive, Estes said, noting that pregnancy itself increases the chances of having a blood clot in the leg or lung much more than any birth control pill.

An FDA-funded review that prompted this week's advisory panel meeting was first released in October, and involved the medical histories of more than 800,000 American women, all of whom were on some type of birth control between 2001 and 2008. The study found that women taking the newer oral contraceptives experienced a higher rate of clots than women on older forms of "the pill."

The review also found that women on two other forms of birth control -- the Ortho Evra patch and the NuvaRing vaginal ring from Merck -- had a higher rate of clots.

The October announcement came a day after the release of a study in BMJ that also found newer birth control pills were tied to a higher risk for clots.

In that study, researchers reviewed data on all Danish women, aged 15 to 49, who were not pregnant between January 2001 and December 2009. During that time, more than 4,200 first episodes of clots occurred.

Women taking birth control pills with the newer progestin hormone had twice the risk of clots compared to those who took the older form of contraceptive pills, the study found.

Compared to women who did not use birth control pills, the clot risk was three times higher among those who used pills with levonorgestrel, and six times higher among those who took pills with drospirenone, desogestrel or gestodene.

But the absolute risk of blood clots associated with the newer pills remained relatively low, about 10 per 10,000 women, according to the University of Copenhagen researchers.

More information

The American College of Obstetricians and Gynecologists has more about birth control pills.

SOURCES: Tara Narula, M.D., cardiologist, Lenox Hill Hospital, New York City; Christopher Estes, M.D., assistant professor, obstetrics and gynecology, University of Miami School of Medicine; Oct. 27, 2011, statement, U.S. Food and Drug Administration; Oct. 26, 2011, BMJ, online; Associated Press


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