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Danco Mifeprex adverse events

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Executive Summary

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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