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.