(Adds additional FDA comments, background)
WASHINGTON, Jan 18 (Reuters) - The label for a Johnson & Johnson JNJ.N contraceptive patch will include new data from a second study showing a higher risk of blood clots compared with birth-control pills, U.S. regulators said on Friday.
Prescribing instructions for the Ortho Evra patch were revised in 2006 to include a warning about a study suggesting women could face a doubling of blood clot risks. Another study, also included on the label, found the chances were equal with the patch and the pill.
The U.S. Food and Drug Administration said the newest findings backed earlier concerns that patch users may face greater dangers than women who take the pill.
“Even though the results of the three studies are conflicting, the results from two of the studies support FDA’s concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women,” an agency statement said.
The newest study of women ages 15 to 44 also found blood clots known as venous thromboembolisms (VTE) were about twice as likely in women using the patch versus birth-control pills, the FDA said.
The agency said it believes “Ortho Evra is a safe and effective method of contraception when used according to the labeling.”
The label recommends that women with concerns or risk factors for serious blood clots talk with their doctors.
“Women should discuss with their health-care provider the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily,” the FDA said.
Scientists have known for years that the estrogen used in contraceptives raises the risks of blood clots, which can cause heart attacks or strokes. Women who use Ortho Evra are exposed to about 60 percent more estrogen than pill users.
Still, the chances of developing a blood clot while using a hormonal contraceptive are low. For every 10,000 women who use a hormonal contraceptive for a year, about three to five of them will develop a clot, FDA officials have said.
Ortho Women’s Health & Urology, the J&J division that makes the contraceptive patch, said in a statement it worked with the FDA on the label change.
“Ortho Evra, like all hormonal birth control, has risks and benefits. It is important that women speak to their health-care professional to determine the option that is right for them,” the company said. (Reporting by Lisa Richwine, Editing by Tim Dobbyn, Leslie Gevirtz)
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