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
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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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.
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's Risk Communication Advisory Committee likes the concept of a standardized format in drug promotional labeling and print advertising, but remains concerned that different risk levels for different populations could negate its utility.