WEDNESDAY, Nov. 16 (HealthDay News) -- The U.S. Food and Drug Administration has revised the label for the Ortho Evra contraceptive patch to warn health care providers and patients that it exposes women to higher estrogen levels than most birth control pills.
Ortho Evra was the first prescription patch approved for birth control. Applied weekly, it releases ethinyl estradiol and norelgestromin through the skin into the bloodstream.
"Women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy," the FDA says.
The new bolded warning states that women using Ortho Evra are exposed to about 60% more total estrogen in their blood than are women taking a typical birth control pill containing 35 micrograms of estrogen. "However, the maximal blood level of estrogen (peak blood levels) is about 25% lower with Ortho Evra than with typical birth control pills," the FDA adds.
The manufacturer, Ortho-McNeil Pharmaceutical, is conducting additional studies to compare the risk of serious blood clots in women using Ortho Evra to that in women who take typical birth control pills, the FDA says.
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