Ortho Evra Contraceptive Patch Linked to Increased Estrogen Exposure

Yael Waknine

Disclosures

November 11, 2005

Nov. 11, 2005 — The U.S. Food and Drug Administration (FDA) approved new labeling today regarding the increased level of estrogen exposure associated with use of an ethinyl estradiol/norelgestromin transdermal system (Ortho Evra, made by Ortho McNeil Pharmaceuticals, Inc.) compared with most oral contraceptives.

The warning was based on the results of pharmacokinetic studies showing that steady-state levels of ethinyl estradiol were increased by 60% in patch users compared with those taking once-daily oral contraceptives containing 35 µg of estrogen. However, use of the transdermal patch also yielded a 25% decrease in maximal exposure.

Although use of the weekly patch may reduce the risk of pregnancy in women who are noncompliant with a daily oral contraceptive regimen, the FDA advises that the potential risks of increased estrogen exposure (eg, thrombotic adverse events) be considered prior to use of the product.

The FDA notes that it remains unclear whether women using the patch are at higher risk for serious adverse events compared with those taking oral contraceptives.

Further information regarding the ethinyl estradiol/norelgestromin transdermal contraceptive system may be obtained by contacting the FDA Division of Drug Information at 1-888-INFO-FDA (1-888-463-6332), or by sending an email to druginfo@cder.fda.gov.

Adverse events related to the use of the contraceptive patch devices should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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