Advocacy Group Calls For Ortho Evra to Pulled From the Market

Scott Kappes

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Today the watchdog group Public Citizen petitioned the U.S. government to pull the birth control patch Ortho Evra from the market. Ortho Evra has been linked to higher rates of blood clots and other complications than birth control pills. Some studies have even placed the risk as twice that of the more traditional pill. When the FDA approved the patch in 2001, it became an instant hit among women who wanted an easier alternative to the daily pill; however, by 2004 studies had linked the patch to elevated risks of blood clots. In 2005 the FDA updated the label of Ortho Evra to advise patients of the increased risks associated with the patch.

Just shy of 10 million prescriptions were filled for Ortho Evra in 2004, while by 2007 demand had dropped off considerably to only 2.7 million. Dr. Sydney Wolf, of Public Citizen, argued to day that Ortho Evra offers no increased contraceptive benefit to make up for the increased risks.

Despite the risk, Wolfe said abruptly cutting off users could result in unwanted pregnancies. So he urged the FDA to phase out patch sales with a six-month period during which existing users could only get refills, allowing them time to switch to another contraceptive.

The FDA said that they have not yet had time to review the petition submitted by Public Citizen, but said that that they will respond directly to the advocacy group once the petition has been evaluated.