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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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.
Read the complete MedWatch 2005 Safety Summary, including links to the FDA News Release and Drug Information page, at:
http://www.fda.gov/medwatch/safety/2005/safety05.htm#evra
Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to
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