Higher Estrogen Exposure with Ortho Evra Contraceptive Patch
FDA Patient Safety News: Show #47, January 2006

Ortho McNeil Pharmaceuticals recently updated the labeling for the company's contraceptive patch, Ortho Evra. The new labeling warns that women using the patch are exposed to higher levels of estrogen than with most birth control pills.

A woman using the weekly patch may be exposed to about 60% more estrogen on average than if she were taking a daily birth control pill containing a typical 35 microgram dose of estrogen. However, the peak levels of estrogen are about 25 percent lower with the patch than with a typical birth control pill.

Increased estrogen exposure may increase the risk of adverse events such as blood clots, but at this point it's not known whether women using Ortho Evra have a higher risk of serious side effects than women taking typical birth control pills. Ortho McNeil Pharmaceuticals is conducting additional studies to examine this question.

Additional Information:

FDA MedWatch Safety Alert - Ortho Evra (norelgestromin/ethinyl estradiol transdermal system).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm122101.htm