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Contraceptive patch gets new FDA warning.(News)

Skin & Allergy News

| January 01, 2006 | Worcester, Sharon | COPYRIGHT 2009 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

The Ortho Evra contraceptive patch exposes women to higher steady state estrogen levels than do most birth control pills, and concerns that such exposure could increase the risk for blood clots prompted an update to the product's label.

The Food and Drug Administration and Ortho-McNeil Pharmaceutical Inc., the product's manufacturer, added the updates, including a new bolded warning stating that women who use the patch are exposed to an average steady state concentration of ethinyl estradiol that is about 60% higher than if they took a typical birth control pill containing 35 mcg of ethinyl estradiol.

In contrast, peak concentrations of ethinyl estradiol are…

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Source: HighBeam Research, Contraceptive patch gets new FDA warning.(News)

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