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FDA Revises Mifeprex “Black Box” To Warn About Infection, Bleeding

This article was originally published in The Pink Sheet Daily

Executive Summary

Revised labeling resulted from reports of “serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death,” FDA says. The new language is significantly stronger than the original black box, which focused on the potential failure of Danco’s mifepristone to result in a complete abortion.

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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.

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.

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