Labeling Warning for Contraceptive Patch

The FDA has approved updated labeling for Ortho-McNeil’s contraceptive patch, Ortho Evra®, to warn health care providers and patients that this product exposes women to higher levels ofestrogen than most oral contraceptives. Ortho Evra® was the first skin patch approved for birth control.

The patch releases the estrogen hormone ethinyl estradiol and the drug progestin hormone norelgestromin through the skin into the bloodstream.

Women taking this product should consult their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because the patch is changed once a week, it decreases the chance that one or more daily doses might be missed, as may occur with birth control pills.

The new bolded warning states that users of the product are exposed to about 60% more estrogen than if they were taking a typical birth control tablet containing 35 mcg of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra® than with the tablets.

The FDA is continuing to monitor safety reports for problems with the patch.