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

ed 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
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