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Mifeprex Labeling Change: “Routine” Response To Adverse Events, FDA Says

Executive Summary

FDA's decision to strengthen warnings on Danco's Mifeprex (mifepristone) is not a signal that the agency will move to pull the product off the market, Center for Drug Evaluation & Research Acting Director Steven Galson, MD, said Nov. 16

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Danco Mifeprex adverse events

Revised 1labeling for Danco's abortifacient Mifeprex (mifepristone/RU-486) expands list of potential adverse reactions to include allergic reaction, hypotension, light-headedness, loss of consciousness, post-abortal infection, ruptured ectopic pregnancy, shortness of breath and tachycardia. Reports of infections, ruptured ectopic pregnancies and bleeding prompted FDA to strengthen Mifeprex' "black box" warning in November (2"The Pink Sheet" Nov. 22, 2004, p. 8)...

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