New Study Leads to Label Update on the Ortho Evra Patch
A study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson has led the Food and Drug Administration to approve of label changes to the Ortho Evra Birth Control Patch. The label changes include findings of the epidemiology study that found users of the patch were at a higher risk of developing blood clots know as venous thromboembolism (VTE) than were users of birth control pills. VTE has been known to lead to pulmonary embolism. The recent study used women aged 15-44 and supports an earlier report that agreed with the findings. The FDA still believes that Ortho Evra is safe when used following the labels instructions. In September 2006, the FDA revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. The original BCDSP study showed there was not an increased risk compared to women using birth control pills. In contrast, a study conducted by i3 Ingenix, showed that some women using the patch were at twice the risk of developing VTE. It is interesting the variation of the findings by BCDSP between the study in 2006 and the most recent one.
