FDA has approved changes to the Ortho Evra label to inform patients and healthcare professionals of the findings of a recent study funded by FDA to assess the risk of blood clots associated with several different hormonal birth control medications (contraceptives), including the Ortho Evra transdermal patch. The Ortho Evra label already contains the results from four other studies that looked at the possible risk of blood clots with Ortho Evra. The addition of the new FDA-funded study does not change FDA's conclusions about a possible increased risk of blood clots associated with use of Ortho Evra. Labeling will include an updated table that presents results of the four previously completed studies together with results from the recent FDA-funded study.
Information from these studies was discussed at a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (Joint Advisory Committee) in December 2011. The Joint Advisory Committee was convened to discuss the benefits and risks of Ortho Evra for the prevention of pregnancy, and specifically the possibly increased risk of blood clots in users of Ortho Evra compared to women who use certain birth control pills. The Joint Advisory Committee reviewed and discussed the methodology and results of all available studies and the overall benefit/risk profile of Ortho Evra. The Joint Advisory Committee recommended that Ortho Evra remain on the market as an option for contraception but that the label be revised to more clearly describe the risks and benefits associated with Ortho Evra.
Labeling and Regulatory History from Drugs@FDA
FDA Approves Update to Label on Birth Control Patch[ARCHIVED]
FDA press release (1/18/2008)
Ortho Evra Questions and Answers (1/18/2008)[ARCHIVED]
- Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) Prescribing Information and Patient Package Insert Jan 20083
Ortho Evra Questions and Answers (9/20/2006)[ARCHIVED] FDA Updates Labeling for Ortho Evra Contraceptive Patch[ARCHIVED]
FDA press release (11/10/2005)