FDA advisers: Ortho Evra patch needs clearer label

U.S. drug advisers recommended that the label for Johnson and Johnson’s Ortho Evra birth control patch be simplified to better explain the risk of blood clots.

In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. It is the only contraceptive patch sold in the United States.

The panel voted 19 to 5 that the patch’s risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.

“I’m satisfied generally with what the content is for this label, it’s the understandability and presentation that needs some work,” said Jacqueline Gardner, panel member and a University of Washington professor.

All commonly used birth control pills increase women’s chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of the hormone estrogen than a pill.

The current label, which has undergone numerous revisions over the past decade, has a boxed warning of a higher risk compared to older birth control pills. But a new FDA study earlier this year again showed that women using the patch were about 60 percent more likely to experience venous thrombotic events (VTEs).

With VTEs, blood clots occur in one of the deep veins in the body, such as the leg or pelvis, and then may travel to the lungs, which could lead to stroke or death.

The same group of advisers on Thursday recommended a more detailed description of blood clot risks and studies for a popular new generation of contraceptive pills, such as Bayer AG’s Yaz and Yasmin.

Those pills contain the compound drospirenone, which has been linked to higher risk of venous and arterial thrombotic events, when a blood clot forms in a leg and can travel to the lung to cause stroke or even death. Ortho Evra does not contain that compound.

“Yesterday we were looking at just another pill, there was no additional benefit to offset additional risk,” said Michele Orza, policy analyst at the National Health Policy Forum who represented consumers at the panel.

“In this case, I think there is additional risk but it is a unique kind of product. There is no alternative (patch) for women who desire hormonal contraception but can’t take the pill for some reason.”

Of all contraceptive alternatives to pills and intra-uterine devices in the United States, the Ortho Evra patch is the second most popular behind Nuvaring, Merck & Co Inc’s vaginal ring, according to IMS Health data. Sales of the patch reached $124 million last year, according to IMS, which is a nearly 50 percent decline over the past five years.

The FDA usually follows its advisers’ recommendations.

J&J shares closed 1.2 percent higher at $64.53 on the New York Stock Exchange on Friday.


By Alina Selyukh

ADELPHI, Maryland

Provided by ArmMed Media