OrthoEvra Contraceptive Transdermal Patch (January 19, 2008)

FDA modified prescribing information for OrthoEvra Contraceptive Transdermal Patch to include the results of a new study conducted by the Boston Collaborative Drug Surveillance Program showing that users of the birth control patch were at higher risk for developing serious blood clots than women using birth control pills. The patch was studied in women aged 15-44. FDA believes that OrthoEvra is a safe and effective method of contraception when used according to the labeling which recommends that women with other risk factors for serious blood clots use an alternative form of contraception.