Ortho Evra Recall Should Be Phased In Over Six Months: Consumer Group

A consumer watchdog group has renewed calls for the Ortho Evra birth control patch to be removed from the market, due to an increased risk of blood clot. 

Earlier this month, Public Citizen asked a panel of outside advisors to the FDA to determine that the risks of Ortho Evra side effects outweighed its benefits.

Although the panel voted to allow the birth control patch to remain on the market with new label warning language, Public Citizen criticized the decision not to recommend an Ortho Evra recall.

Ortho Evra has had 12 different label changes since it was approved in November 2001. Six were related to the large amount of hormones and progestin released by the patch into the body, which a recent FDA analysis found significantly increased the risk of blood clots and venous thrombotic events (VTEs) in women.

Public Citizen testified that Ortho Evra has had enough label changes (pdf), and a new one will not make the patch any safer. Instead, the group is reiterating its long-standing call for the FDA to recall the Ortho Evra birth control patch.

“A pill delivering such an exposure would never be approved,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “If the Ortha Evra patch has no unique benefits and, relative to equally effective oral contraceptives with lower estrogen doses, has a higher risk of blood clots, there is no reason to leave it on the market.”

The FDA advisory panel ultimately voted 19-5 that the benefits of the Ortho Evra patch continue to outweigh the risks, but Public Citizen has called for the patch to be phased out over a six month period to allow women to switch to an alternative form of contraception.

The group’s recommendations are unlikely to be heeded by the FDA. While the agency is not bound to follow the advisory committee’s recommendations, it’s advice usually has a significant impact on the FDA’s final decision.

Ortho Evra is a form of birth control that is delivered through a patch placed on the shoulder, arm, abdomen or on the back near the buttock. While it is promoted as an alternative to daily birth control pills, some studies have shown that the Ortho Evra patch delivers substantially more estrogen and significantly increases the risk of blood clots and venous thrombotic events (VTEs) in women.

A recent FDA study of all of the newer forms of birth control indicated that women who use the Orth Evra patch or the NuvaRing birth control ring may be 55% more likely to suffer a VTE, which can lead to a pulmonary embolism, heart attack or stroke, than women who take levonorgestrel-based birth control pills. Women who took Yaz, Yasmin or other generic pills that also use the drospirenone progestin, faced a 75% increased risk of VTE and twice the risk of heart attack or stroke.