FDA says OC patch must update VTE warnings

April 1, 2008

The Food and Drug Administration says the Ortho Evra Contraceptive Transdermal Patch must update information on its label regarding the risk of venous thromboembolism (VTE). . .

The Food and Drug Administration says the Ortho Evra Contraceptive Transdermal Patch must update information on its label regarding the risk of venous thromboembolism (VTE) to reflect the results of a recent epidemiologic study that found that women between the ages of 15 and 44 are at increased risk for VTE compared with women using birth control pills. The study was conducted by the Boston Collaborative Drug Surveillance program on behalf of Johnson and Johnson.

The federal agency says the increased risk is due to the fact that women using the patch are exposed to about 60% more estrogen than those taking a typical birth control pill containing 35 μg of estrogen.

In a January 18, 2008 statement, FDA reiterated that it believes Ortho Evra to be a safe and effective method of contraception, but that women should be kept abreast of new safety and efficacy data that could impact their health-care decisions. For additional information, see http://www.fda.gov/cder/drug/infopage/orthoevra/default.htm.