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.
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Public Citizen losses again as the agency says current product labeling for desogestrel-containing oral contraceptives adequately describes the risk of venous thromboembolism; FDA notes the difficulty in comparing the magnitude of risks between combination OCs.
Uncertainty remained the dominant opinion about the risk for blood clots with the four Bayer contraceptives at the conclusion of a Dec. 8 joint meeting of the Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees. One thing panelists were sure of was that they didn’t want a summary conclusion about the risks in labeling. But they didn’t want a lengthy discussion of data, either.
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.