Ortho Evra®: (Norelgestromin and ethinyl estradiol transdermal system (patch))

FDA has approved changes to the Ortho Evra label to include the results of an additional epidemiology study designed to evaluate the risk of developing serious blood clots, also known as venous thromboembolism (VTE), among women aged 15-44 when using Ortho Evra.

Even though the results of the three studies are conflicting, the results from two of the studies support FDA’s concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women.  The label continues to recommend that women with concerns or risk factors for thromboembolic events talk with their healthcare provider about using Ortho Evra versus other contraceptive options.

Norelgestromin and ethinyl estradiol transdermal system (The Ortho Evra Patch) is used to prevent pregnancy. Norelgestromin is a progestin and ethinyl estradiol is an estrogen. Estrogen and progestin are two female sex hormones. Norelgestromin and ethinyl estradiol contraceptive patch works by preventing ovulation (the release of eggs from the ovaries) and by changing the cervical mucus and the lining of the uterus. The contraceptive patch is a very effective method of birth control, but it does not prevent the spread of human immunodeficiency virus [HIV; the virus that causes acquired immunodeficiency syndrome (AIDS)] and other sexually transmitted diseases.

Information taken from the United States National Library of Medicine and the FDA.