FDA Adds Elevated Estrogen Warning to Birth Control Patch Labels

By Elizabeth Rhein

Published on November 23, 2005

The Food and Drug Administration has added a warning to the labels of the Ortho Evra birth control patch, notifying users of increased estrogen exposure compared to regular birth control pills. 

This increased exposure to estrogen has been linked to a possible increase in the risk of blood clots for patients using the patch, according to studies completed by the drug's manufacturer, Ortho McNeil Pharmaceuticals.

The additional warning, to be printed in bold type on Ortho Evra labels, states that women who use the patch are exposed to up to 60 percent more estrogen than are women who use traditional birth control pills. Ortho McNeil is conducting further studies on the drug, in an effort to determine blood clot risk in women using the patch versus those taking pills.

Women currently using the Ortho Evra patch are urged to speak with their healthcare providers to determine whether continued use of the patch is right for them. Women that have suffered blood clots after Ortho Evra use may have a defective drugs case.

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