New estimates of VTE risk added to Ortho Evra PI

January 22, 2008

Information on VTE risk added to prescribing information for Ortho Evra

Two new estimates of relative risk for venous thromboembolism (VTE) have been added to the prescribing information (PI) for contraceptive patch, Ortho Evra (norelgestromin/ethinyl estradiol transdermal system). The odds ratio from one estimate was 1.1, indicating no increase in risk for VTE and the other was 2.0, indicating twice the risk for VTE while using the patch, compared with women taking oral contraceptives. According to the manufacturer, Ortho-McNeil-Janssen Pharmaceuticals, the previous labeling also listed two estimates of relative risk for VTE: 0.9 (indicating no increase in risk) and 2.4 (an approximate doubling of risk). The new information will be presented in table format in the Warnings section of the PI and is based on results of a study conducted by the Boston Collaborative Drug Surveillance Program, involving women aged 15 to 44 years.

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