FDA Warns Clot Risk Higher in Birth Control Patch Than Pill

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The patch does have a checkered past. In November 2006, a group of 43 women sued the product's New Jersey-based maker, Ortho-McNeil Pharmaceutical Co. (a subsidiary of Johnson & Johnson), and San Francisco-based distributor McKesson Corp, alleging that they suffered blood clots and other health woes after being placed on Ortho-Evra.

"This product should not be on the market," Shawn Khorrami, an attorney for the plaintiffs, told the Associated Press at the time. "When you put out a product that gives women more hormones than they need, then you're increasing their risk of developing those ailments."

Similar worries have surfaced in Canada. But Janssen-Ortho, the patch's Canadian distributor, defended the product. "The risk of serious adverse events is small in healthy women, but increases significantly if associated with the presence of other risk factors, such as obesity or smoking," the company said in a statement.

The FDA is also stressing proper use of the Ortho Evra patch. In its statement issued Friday, the agency said it believes the product "is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health-care provider about using Ortho Evra versus other contraceptive options."

Sidney Wolfe, director of the Washington, D.C.-based consumer advocacy group Public Citizen, told Toronto's The Globe and Mail newspaper that women "shouldn't use [the patch]. It shouldn't be used because it's a new product with no unique advantage."

One gynecologist begged to differ, however. "When you look at any estrogen-containing contraceptive product available on the market, whether it's the Pill or the Evra patch or NuvaRing, the vaginal ring, all of them slightly increase the risk of blood clot," Dr. Melissa Mirosh, former fellow of the contraceptive advice, research and education fellowship program at Queen's University in Kingston, Ontario, told the Canadian Press.

More information

There's more on reproductive health at the U.S. Centers for Disease Control and Prevention.