Claris Law Legal Blogging Community

Editor: Robert Blanchard
Profession: Attorney at Law

Category: Ortho Evra Warnings

In September 2006, the FDA decided to update the Ortho Evra birth control patch label to reflect a serious warning to women using it. The updated label cites a study that shows that use of the patch can double a woman's risk of blood clots and other complications, when compared with use of birth control pills.

According to a Sept. 20 question and answer document about Ortho Evra on the FDA Web site, the revision to the label includes a new bolded warning about higher estrogen exposure.

A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. There are also high dose estrogen pills on the market, such as the 50 microgram birth control pills, and some women need these. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.