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Public Citizen Demands Removal of J&J’s Ortho Evra Patch From Marketplace

This article was originally published in The Pink Sheet Daily

Executive Summary

Petition to FDA claims drug exposes women to 60 percent more estrogen and may increase the risk of blood clots two-fold.

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Transdermal Delivery Trumps Advisory Panel Concerns About Blood Clots With J&J’s Ortho Evra

With an eye toward keeping the contraceptive patch as an alternative to birth control pills, the Reproductive Health Drugs and Drug Safety and Risk Management Committees voted 19-5 on Dec. 9 that the benefits of the contraceptive patch outweigh its risks.

Ortho Evra’s First Hurdle Is Advisory Panel; Second Is Withdrawal Petition

As Public Citizen presses to get J&J’s transdermal birth control pulled from the market, data suggest a higher risk of blood clots with the patch than with combination oral contraceptives, FDA says, but none of the studies provide a definitive answer on the drug’s relative safety.

FDA Intellectual Bias Policy Takes Wolfe Off Contraceptives Safety Review

FDA offered Public Citizen’s Sidney Wolfe a seat at the table for discussion, but no vote. Members need to report relevant information about their conflicts in a timely manner, the agency says.

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