A popular consumer watchdog group, Public Citizen, has not given up on recalling a birth control patch that they believe has no business being on the market. The once popular patch, Ortho Evra, needs to be removed from the market, due to an increased risk of blood clot, the group states.
But this is not a new battle for them. In May of 2008, Public Citizen first called for the recall, citing several reasons that they believed the patch was unsafe. And, now yet again, earlier in December, Public Citizen asked a panel of outside advisors to the FDA to determine that the risks of Ortho Evra side effects outweighed its benefits.
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.
Studies show the Ortha Evra patch delivered estrogen (ethinyl estradiol) at levels approximately 60 percent higher than oral contraceptives, Public Citizen said in testimony to the FDA’s Drug Safety and Risk Management and Reproductive Health Drugs advisory committees.
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, 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. Although prescriptions have dropped markedly in the past seven years, more than a million prescriptions a year are still filled for the patch. Women using these prescriptions are at increased risk with no significant, documented benefit.”
The FDA advisory panel ended up voting against Public Citizen’s recommendations, and voted 19-5 that the benefits of the Ortho Evra patch continue to outweigh the risks. This does not change the fact that Public Citizen has still called for the patch to be phased out over a six month period to allow women to switch to an alternative form of contraception.
Unfortunately, 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.
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