Ortho Evra Patch: Clot Risk Updated
Label Adds Details From 2 Conflicting Studies on Nonfatal Blood Clots
Sept. 20, 2006 -- The Ortho Evra patch is getting new labeling with more information on the risk of nonfatal blood clots associated with the patch.
The clotting risk isn't new, and the patch's warning about that risk isn't being strengthened.
The label change simply adds information from two observational studies, publicized by the FDA in February, about clotting risk in women using the patch or birth control pills containing 35 micrograms of estrogen.
The FDA's Daniel Shames, MD, spoke to reporters about Ortho Evra.
Shames is the acting deputy director of the Office of Drug Evaluation III at the FDA's Center for Drug Evaluation and Research.
"We still believe that the risk-benefit profile is appropriate for this particular contraceptive and it's safe and effective when taken with the appropriate label indication," Shames says.
He says the FDA is publicizing the label change to provide information.
"This is consistent with our policy to try to give information as soon as we know it when we think it's reliable information, even at times when we cannot make a specific change in our recommendations," Shames says.
Risk Not New
Ortho Evra, like other hormonal contraceptives, already warned users "not to smoke and not to use the product if they have a history of blood clots, stroke, heart attack, or certain cancers," Shames says.
The patch also already encouraged women "to discuss with their health care professional whether Ortho Evra was the right method of contraception for them," says Shames.
A statement from Ortho Evra's maker, Ortho Women's Health & Urology, encourages Ortho Evra users to consult their doctors with any questions. The company, a branch of Ortho-McNeil Pharmaceutical, also pledges more studies on the topic. Ortho-McNeil is a WebMD sponsor.
The two studies included data from two insurance companies and had conflicting results, says Shames.
The data covered 400,000 to 500,000 women aged 15-44 using the patch or birth control pills containing 35 micrograms of estrogen.
The studies were purely observational, meaning that women weren't assigned to use either type of birth control. So they didn't directly test the patch as a clot cause.