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 Dec. 9, 2011

Ortho Evra Birth Control Patch Needlessly Exposes Patients to Excessive Levels of Hormones, Should Be Removed From Market

Birth Control Patch Delivers More Than Twice the Amount of Hormones as Oral Contraceptives

WASHINGTON, D.C. – The Ortho Evra birth control patch exposes women to dangerously high levels of estrogen and increased risk of blood clots and should be removed from the market, phased in over six months to allow women to switch to an alternative form of contraception, Public Citizen told two Food and Drug Administration (FDA) advisory committees today.

In fact, the Ortha Evra patch delivered estrogen (ethinyl estradiol) at levels approximately 60 percent higher than oral contraceptives, Public Citizen said in testimony to the FDA’s Drug Safety and Risk Management and Reproductive Health Drugs advisory committees.

There are more than 60 birth control pills on the market, all with a maximum of only 35 micrograms (mcg) of ethinyl estradiol or less. Comparatively, the Ortha Evra patch contains an equivalent exposure of estrogen that women would get with a 60-mcg pill.

“A pill delivering such an exposure would never be approved,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “If the Ortha Evra patch has no unique benefits and, relative to equally effective oral contraceptives with lower estrogen doses, has a higher risk of blood clots, there is no reason to leave it on the market. Although prescriptions have dropped markedly in the past seven years, more than a million prescriptions a year are still filled for the patch. Women using these prescriptions are at increased risk with no significant, documented benefit.”

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