Birth-Control Patch Label To Have New Risk Data

The Food and Drug Administration said a Johnson & Johnson birth-control patch will carry information about the possibility the product might increase the risk of blood clots in women beyond that seen in typical birth-control pills.

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The agency said the label will carry a discussion of two recent clinical studies of the patch that were conducted in the wake of concerns about possible increases in clot risk. The two studies show conflicting results, the FDA said.

One study suggests the birth-control patch doesn't carry a blood clot risk higher than a birth-control pill, while the other suggests an almost twofold increase in the risk of venous thromboembolism, or blood clots. Preliminary results of the studies were released in February, and the updated findings released yesterday are similar.

Agency officials said they are asking that the studies, involving nearly 500,000 women from two large insurance databases, continue for at least an additional 18 to 24 months. The Johnson & Johnson unit that makes the patch and is paying for the studies agreed to do so.

"Even though the results of the two studies are conflicting, the results of the second epidemiology study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women," the FDA said. "The label has recommended and continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their health-care provider about using Ortho Evra versus other contraceptive options."

Because of those concerns, Ortho Evra's label was previously updated last November to warn of a possible increased blood clot risk from the patch. The new label update will contain the information from the two studies.

"Let us be clear. We cannot conclude that there is a greater risk," said Daniel Shames, the FDA's director of the division of reproductive and urologic drug products. He said the FDA still believes that the birth-control patch carries an "acceptable" risk-benefit profile and that women and their doctors need to weigh a possible increased risk of blood clots with the risk of getting pregnant.

Dr. Shames said the typical hormone contraceptive user faces a higher risk of developing blood clots. About three to five women in 10,000 using contraception for a year would be expected to develop a blood clot compared with one in 10,000 women not on contraceptives.

Even if the patch truly does double the risk of blood clots, Dr. Shames said in actual numbers it would translate into about six women in 10,000 using contraception for a year actually getting a clot.

Some women have trouble remembering to take daily birth-control pills, thereby increasing their risk of getting pregnant. The patch, which has been used by more than five million women since it was approved in 2002, is applied to the skin and is changed once a week.