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U.S. Department of Health and Human Services

Safety

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Mifeprex (mifepristone) Nov 2004

Audience: Reproductive healthcare professionals and consumers

Danco Laboratories and FDA notified healthcare professionals of revisions to the BOXED WARNING and WARNINGS sections, the MEDICATION GUIDE and PATIENT AGREEMENT of the Prescribing Information to describe serious and sometimes fatal infections and bleeding that may occur following the use of Mifeprex.

[November 15, 2004 - Drug Information Page - FDA]