Public Citizen Calls On FDA To Withdraw Ortho Evra Patch From Market Over Safety Concerns

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Regulatory Affairs / Drug Approvals
Article Date: 12 May 2008 - 0:00 PDT

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Public Citizen's Health Research Group on Thursday filed a petition with FDA calling on the agency to withdraw the birth control patch Ortho Evra from the market because of safety concerns, Reuters reports. In the petition, the consumer advocacy group said the amount of estrogen released from the patch -- made by Johnson & Johnson subsidiary Ortho McNeil -- varies among women, which could result in up to double the number of blood clots and other negative health effects (Heavey, Reuters, 5/8). Sidney Wolfe, head of the group, suggested that FDA phase out sales of the patch during a six-month period so that only existing users can get refills, allowing them enough time to switch to another contraceptive (AP/Google.com, 5/8).

FDA in January announced that the label for Ortho Evra will include new data on a study that found a higher risk of blood clots among women who use the patch. The study found that women ages 15 to 44 who use the patch are about twice as likely to have blood clots as women who use oral contraceptives. According to Reuters, women who use Ortho Evra are exposed to about 60% more estrogen than oral contraceptive users. FDA officials have said that the risk of developing blood clots while using hormonal contraceptives is low -- for every 10,000 women who use a hormonal contraceptive for one year, about three to five will develop a clot.

Wolfe wrote that the "considerable safety concern of high-dose, variable estrogen exposure tips the balance of risks and benefits against the availability of Ortho Evra as a contraceptive." He added, "If Ortho Evra had been designed as a pill, it is unlikely to have been approved because of its increased estrogen content" (Reuters, 5/8). Gloria Vanderham, a spokesperson for J&J, said, "Ortho Evra is a safe and effective hormonal birth control option when used according to its labeling." She added, "Hormonal birth control methods have benefits and risks. The approved labeling has always stated the known risks associated with its use." (AP/Google.com, 5/8).

Use of the patch has decreased in recent years. Last year, about 2.7 million prescriptions were written for the patch, down from more than 9.9 million prescriptions in 2004, according to data cited by the petition. FDA said that it has not reviewed the petition but that it will respond directly to Public Citizen after it does (AP/Google.com, 5/8).

The petition is available online.

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