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UPDATE 2-J&J contraceptive patch to include more risk data

Fri Jan 18, 2008 6:29pm EST
 
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(Adds additional FDA comments, background)

WASHINGTON, Jan 18 (Reuters) - The label for a Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz) 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.  Continued...

 

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