Warning issued for Ortho Evra birth control patch

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Warning issued for Ortho Evra birth control patch

Ortho Evra users at greater risk of blood clots and other complications.

What happened: On Nov. 11, 2005, the Food and Drug Administration (FDA) announced a revision to the label for Ortho Evra, the key ingredient in the birth control patch, warning women that they were being exposed to a higher level of estrogen than previously thought. The FDA cautions that exposure to higher levels of estrogen may put Ortho Evra users at increased risk of blood clots and other serious side effects.

The new warning states that women using this patch are exposed to 60 percent more estrogen than are women who use a typical 35-microgram birth control pill. Adverse effects of estrogen use — in either pill or patch form — include blood clots in the legs or lungs as well as heart attack and stroke.

Ortho Evra — the only birth control patch — has become increasingly popular since first going on sale in 2002.

What does this mean to you? In general, the higher the amount of estrogen you're exposed to, the greater your risk of serious side effects. However, it's unknown whether you're at higher risk of serious side effects if you use Ortho Evra than if you use a typical birth control pill. The health risks associated with estrogen use are higher if you're a smoker and you're over age 35.

Studies so far are inconclusive regarding the comparative risk of using Ortho Evra versus birth control pills. One study reported in February 2006 suggested a higher risk of blood clots among users of Ortho Evra; another study found the risk about the same for women using either Ortho Evra or the birth control pill. More research is needed, the FDA said following release of the two studies.

If you're currently using Ortho Evra and you have concerns or want to reconsider your birth control choice, talk with your doctor. Immediately discontinuing Ortho Evra means that you could become pregnant if you have unprotected sex unless you use a backup method of birth control, such as a condom.

Last Updated: 02/21/2006
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