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U.S. Department of Health and Human Services

Safety

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Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)

Audience: Reproductive and other healthcare professionals, and consumers

[Posted 11/14/2005] FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.

[November 10, 2005 - News Release - FDA]
[November 10, 2005 - Drug Information Page - FDA]