Not a secure method

May 9, 2008 18:11 GMT  ·  By

The contraceptive patch has been designed to be more efficient against unwanted pregnancies but, as it turns out, it has stirred up quit a debate, as it seems to be more dangerous than the pill and should be pulled off market. Even more, this doesn't even have something to do with. A few secondary effects have been observed on pills too, like nausea, blood clotting, liquid retention, cardiovascular impairments and apoplexy, but in the case of the patch, they seem to be more severe. "Ortho-Evra is a poor choice for women," Dr Sidney Wolfe of Public Citizen warned the FDA.

A 2005 AP investigation showed that patch users experienced higher rates of life-threatening blood clots than women on birth-control pills. Blood clots represent a side effect of the estrogen-like products. Some researches even pointed out that patch users present a double risk of clots in the legs and lungs compared to women on pills, as the patches release up to 60% more estrogen into the bloodstream. Since 2005, Ortho-Evra's label has a warning about clotting risks.

"Demand has dropped, from about 9.9 million prescriptions filled in 2004 to 2.7 million filled in 2007. And lawsuits by women who claim they were harmed by the patch have unearthed two previously unpublished studies from Johnson & Johnson researchers that found higher estrogen exposure from the patch even before it won FDA approval in 2001," wrote Wolfe.

In fact, the patch does not even provide women with a better contraception. Moreover, a 2008 study showed that contraceptive vaginal rings are more efficient than the patch applied on the skin. Women too are also more satisfied with the vaginal ring.

"Ortho-Evra is a safe and effective hormonal birth control option when used according to its labeling. Hormonal birth control methods have benefits and risks. The approved labeling has always stated the known risks associated with its use." responded Gloria Vanderham, a spokeswoman for patch maker Ortho Women's Health and Urology, a Johnson & Johnson company.

Still, "abruptly cutting off users could result in unwanted pregnancies," said Wolfe, who believes FDA should phase out patch sales with a six-month period, so that users are allowed to change to another contraceptive measure in the meantime.