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Mifeprex Label Will Add Further Language On Infection Risk

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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Mifeprex “Black Box” Warning Revised On Reports Of Sepsis Deaths

Four deaths have been reported in California patients undergoing a medical abortion with Mifeprex (RU-486). Patients did not present with the typical symptoms of infection; a “high index of suspicion” is needed to rule out sepsis, FDA says.

Mifeprex “Black Box” Warning Revised On Reports Of Sepsis Deaths

Four deaths have been reported in California patients undergoing a medical abortion with Mifeprex (RU-486). Patients did not present with the typical symptoms of infection; a “high index of suspicion” is needed to rule out sepsis, FDA says.

Danco Revises Mifeprex Labeling To Add Post-Marketing Adverse Reactions

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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