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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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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.

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.

Bayer Contraceptives Win Advisory Committee Backing As Panel Rejects Call For Comparative Effectiveness

In a 15-11 vote, FDA advisory panel members split on whether drugs containing progestin drospirenone should be judged on absolute risk, or whether their potentially higher risk than other birth control pills should be offset by benefits beyond those provided by alternatives.

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