Danco Revises Mifeprex Labeling To Add Post-Marketing Adverse Reactions
This article was originally published in The Pink Sheet Daily
Executive Summary
Adverse events for the abortifacient include allergic reactions, hypotension, light-headedness, shortness of breath and tachycardia. Reports of serious infections and ruptured ectopic pregnancies prompted FDA to strengthen Mifeprex’ “black box” warning in November.
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Mifeprex Label Will Add Further Language On Infection Risk
Danco is updating the abortifacient label to include additional language on the potential for serious bacterial infection or sepsis following treatment. The company is finalizing language with FDA; it plans to issue a “Dear Doctor” letter to physicians and ER directors when the changes are finalized.