FDA Cites Risks Linked to the Patch

From the Associated Press

Women were warned Wednesday that their risk of blood clots in the legs and lungs might be higher if they use the birth-control patch instead of the pill.

The Food and Drug Administration said it updated the label on the Ortho Evra birth-control patch to reflect the results of one study that found women using the patch faced twice the risk of clots than did women on the pill. However, a second study found no difference in risk between the two forms of birth control.

“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 in a notice published on its Web site.


Initial results of the studies were made public in February by the patch’s manufacturer, Ortho Women’s Health & Urology. The Raritan, N.J.-based company is owned by Johnson & Johnson.

Last year, an investigation by the Associated Press found higher rates of blood clots in women using the patch.

The FDA recommended that women with concerns about use of the patch talk to their doctors.

Johnson & Johnson previously has said that clots remain rare and that they have been reported as a potential risk of all hormonal contraceptives.