FDA panel backs birth-control patch

Associated Press

ADELPHI, Md.

A panel of federal health advisers said Friday that a birth-control patch from Johnson & Johnson probably carries a higher risk of blood clots than older drugs, but should remain available as an option for women who have trouble taking a daily pill.

The Food and Drug Administration’s panel of reproductive health experts voted 19-5 that the benefits of the Ortho Evra patch outweigh its risks, specifically a potentially higher risk of dangerous blood clots in the legs and lungs. Panelists said the patch can be especially useful for younger women who have difficulty sticking to a daily pill regimen.

The FDA sought the experts’ advice as it reviews the safety of newer hormone-based contraceptives launched in the past decade. The agency is not required to follow their advice, though it often does.

Johnson & Johnson’s weekly Ortho Evra patch was approved in 2001 and has been marketed for its convenience as an “option for busy women who are looking to simplify life.” The drug works about as well as other contraceptive medications, allowing about one unplanned pregnancy per year for every 100 women.

Studies assessing Ortho Evra’s blood-clot risk have reached differing conclusions over the years. At least two studies found that patch users have twice the risk of clots as women taking birth-control pills. Even a slightly higher risk can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels, which in rare cases have been fatal, even among young women.

The FDA’s most recent study found that women using the patch have a 50 percent higher risk of clots than women taking various oral contraceptives.