Additional warnings for Ortho Evra

The labeling for Ortho Evra (norelgestromin/ethinyl estradiol transdermal patch, from Ortho-McNeil) has been updated to include additional safety data regarding an increased risk of venous thromboembolism (VTE). The recent findings support earlier studies that showed women using Ortho Evra were at higher risk of VTE than women using oral contraceptives.

Due to the differences in absorption, women using Ortho Evra are exposed to about 60 percent more estrogen than if they were using typical oral contraceptives containing 35 micrograms of estrogen. The increased levels of estrogen may increase the risk of side effects, including VTE. Ortho Evra is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm094909.htm.