Should the Birth Control Patch Be Pulled?

News is looking worse and worse for the contraceptive patch made by Ortho Evra. Well-known consumer health advocate Sidney Wolfe petitioned the Food and Drug Administration yesterday to remove the patch from the market, saying that there's enough research to show that patch users have unacceptable higher risks of dangerous blood clots than those who take birth control pills. The FDA has already slapped a warning label on the patch that's been updated several times to reflect new studies finding that women who wear the patch have about double the risk of developing the clot condition called venous thromboembolism. That's most likely because the patch exposes them to 60 percent more estrogen than what they'd get if they were on a pill containing 35 micrograms of estrogen.

Wolfe wrote in his letter to the FDA that although "demand for the patch has dropped dramatically, from over 9.9 million prescriptions filled in 2004 to 2.7 million prescriptions filled in 2007," the patch is still among the top 200 brand-name drugs prescribed in the United States. I also previously blogged on a study showing that patch users were far more likely to be bothered by breast pain, nausea, and longer and more painful periods than those who used the vaginal ring, another kind of hormonal contraception. And Wolfe cites other research showing patch users are also more likely than pill users to have these side effects.

So is this the death knell for the patch? The FDA hasn't yet responded to Wolfe's petition, so the jury's still out. But I think women may hear this news and think—wrongly—that blood clots aren't an issue if they take the pill or use the ring. After all, Wolfe petitioned the FDA last year concerning birth control pills that contain a new formulation of progestin called desogestrel, that, like the patch, have been shown to double the risk of blood clots. While these are indeed extremely rare for most women, those who fall into certain categories could be at significantly higher risk. These include:

• Smokers: Never take hormonal contraceptives if you smoke; the combination of the two increases the risk of blood clots, heart attacks, and strokes, especially if you smoke more than 15 cigarettes a day and/or are over age 35. Of course, quitting cigarettes will do your heart far more good than avoiding the pill will.

• Those with a family history of blood clots: Did your mom have them? Your sister, your aunts? If so, you could have a genetic predisposition to them. Check with your doctor to see if you can safely take hormones.

• High blood pressure: Blood clots may not be an issue here, but hormonal contraception can up the risk of strokes, especially in those who already have a history of hypertension.

If you don't fall into one of these categories, you can probably relax about the blood clot risks. The typical risk associated with the pill is about 1.5 in 10,000, so even a doubling of a risk would only increase your risk to 3 in 10,000. Those are odds I can live with—considering they're still lower than the risk of developing blood clots during pregnancy.