The FDA recently modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new study that found that users of the birth control patch were at higher risk of developing serious blood clots than women using birth control pills. Such clots can lead to pulmonary embolism, i.e., a blockage of the artery carrying blood from the heart to the lungs. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for the blood clots.
FDA stressed that it still believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, but recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.
See the full FDA release here and Frequently Asked Questions and Answers about its statement regarding Ortho Evra here.
