FDA Panel Cites Clot Risk From Contraceptive Patch

Advisory group recommends Ortho Evra remain available, but with warning on label

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. Both contain a newer type of man-made progestin hormone called drospirenone, which could increase the chances of dangerous clots in the legs or lungs, compared to older forms of oral contraceptives. The newer contraceptives have been successfully marketed on the premise that they have fewer of the unwanted side effects of older hormone pills such as bloating, mood swings and acne.

Speaking ahead of the decision, Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York City, said that the risk of clotting with the newer pills is "a low risk but the risk exists. The idea of the FDA looking at this and potentially increasing the warning has no downside. If anything, it increases awareness and that can only be a good thing."

Earlier Thursday, the panel members voted 15 to 11 that the newer contraceptives, which gained initial FDA approval in 2001, are a viable method of birth control, and that the benefits of preventing pregnancy outweigh the health risks.

While the FDA isn't obligated to follow the recommendations of its advisory panels, it usually does so.

More information

The U.S. Department of Health and Human Services has more about birth control at womenshealth.gov.

SOURCES: Tara Narula, M.D., cardiologist, Lenox Hill Hospital, New York City; Associated Press

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