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FDA’s Risk Disclosure Challenges Highlighted At Contraceptive Advisory Cmte.

Executive Summary

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.

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