New Study Confirms Ortho Evra Risks

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January 22nd, 2008

"FDA Approves Label Change for Ortho Evra"

The Food and Drug Administration approved a labeling change for the Ortho Evra birth control patch based on a new study linking the contraceptive to a greater risk of potentially fatal blood clots than the pill.

Ortho Evra is a transdermal patch that releases estrogen and progestin directly through the skin and into the bloodstream, exposing women to about 60 percent more hormone than oral contraceptives.

Greater hormone levels are associated with increased risks of side effects, including the risk of venous thromboembolism (VTE)—a condition that can lead to fatal pulmonary embolism.

In September 2006, the label of Ortho Evra was updated to reflect this increased risk after a study showed that the patch nearly doubled a woman’s risk of VTE. The new study, which was conducted on women between the ages of 15 and 44, supports the earlier findings.

Injured by Ortho Evra? Contact an experienced attorney near you today to learn more about your legal options.