Ortho Evra Gets Additional Warnings

Scott Kappes

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Last Friday the FDA approved additional changes to the label of the once blockbuster Ortho Evra birth control patch to include results from a new epidemiology study that suggests that users of the patch are at higher risk for developing serious blood clots than those taking birth control pills. These dangerous blood clots are known as venous thromboembolism (VTE), which can lead to pulmonary embolism. These findings support earlier studies further reinforcing elevated risks of VTE associated with the patch.

The Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson, the makers of the patch, conducted the study that prompted the labeling changes. In September of 2006 the FDA advised the label of Ortho Evra to warn an elevated risk of VTE based on two studies.

The FDA still believes that Ortho Evra is a safe and effective form of birth control when used properly. Women with concerns or risk factors for blood clots should explore alternatives and discuss other treatment options with their physicians before using the Ortho Evra patch.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.