Med Watch - Ortho Evra®

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Audience: Reproductive and other healthcare professionals and consumers

Ortho Evra®'s recent labeling changes were released by The Food and Drug Administration (FDA) to healthcare professionals and patients. The new label warnings include a bolded warning about higher exposure to estrogen for women using Ortho Evra® compared to taking a daily birth control pill containing 35 micrograms of estrogen. Women on the Ortho Evra® patch may be exposed to 60% more estrogen than if she were taking a typical birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as heart attacks and strokes. At this time it is not known if users of Ortho Evra® have a higher risk of serious side effects than women taking typical birth control pills.

Reference:

"News Release - Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)," FDA, November 2005.