Group wants birth control patch pulled

Studies link Ortho-Evra to dangerous blood clots, Public Citizen says

Reuters
updated 12:56 p.m. ET, Thurs., May. 8, 2008

WASHINGTON - A U.S. advocacy group is urging the Food and Drug Administration to pull Johnson & Johnson’s birth control patch from the market after studies found an increased risk of dangerous blood clots.

In a petition filed with the FDA on Thursday, Public Citizen’s Health Research Group said the amount of estrogen released from the Ortho-Evra patch varies widely among individual women, causing up to twice as many clots and other painful side effects.

“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,” wrote Sidney Wolfe, head of the research group.

Ortho-Evra has seen its use slip in the wake of such data, which led to warnings on the patch’s label as recently as January, when a study of women ages 15 to 44 found blood clots known as venous thromboembolisms were about twice as likely in women using the patch versus birth control pills.

The FDA at the time said the patch was safe and effective when used as directed and urged patients to talk to their doctors about the risk.

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