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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Contraceptive Compliance Studies May Be Key To Assessing Risk Of Ortho Evra Patch

Some patients in an FDA-funded study had less risk for blood clots than others and finding the reason is a subject for future studies, several members of an advisory panel told FDA Dec. 9. The Reproductive Health Drugs and Drug Safety and Risk Management Committees concluded in a 19-5 vote that the drug’s benefits 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.

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