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FDA Panel Cites Clot Risk From Contraceptive Patch
Date:12/12/2011

By Steven Reinberg
HealthDay Reporter

MONDAY, Dec. 12 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration on Friday said that the Ortho Evra birth control patch carries a higher risk of blood clots for women compared to older methods, but should not be taken off drug store shelves.

The panel, which based its decision on the results of a new review of the data, voted 19 to 5 that the benefits of Johnson & Johnson's Ortho Evra patch exceed its risks, which included a higher risk for blood clots lodging in the legs or lungs.

The panelists felt that the patch, first approved in 2001, remains a valuable option for those younger women who find it tough to stick to a daily regimen of the 'Pill,' the Associated Press reported.

"I have many teenagers and it's the only method they'll use -- for them it's the perfect method," Dr. Melissa Gilliam of the University of Chicago, told the AP.

The panel did vote 20 to 3 (with one abstention) that the patch's labeling requires updating to better inform women of the higher risk for clots.

Studies on risks associated with the patch have had conflicting results. The most recent study by the FDA found a 50 percent higher risk for clots for women on the Ortho Evra patch versus those on various forms of the 'Pill.' But FDA scientists stressed that the data was not conclusive, the AP said.

The news agency said that prescriptions for Ortho Evra have waned over the past five years, from 5 million in 2006 to around 1.3 million in 2010.

Friday's announcement followed on the heels of a decision by the same FDA-appointed panel on Thursday that several newer forms of oral contraceptives carry revised labels warning about an increased risk of potentially fatal blood clots.

The U.S. Food and Drug Administration advisers voted 21-5 in favor of the new labels for oral contraceptives such as Bayer's Yaz or Yasmin
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