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U.S. Department of Health and Human Services

Safety

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Mifeprex (mifepristone) July 2005

Audience: Reproductive healthcare professionals

[Posted 07/19/2005] Danco Laboratories and FDA have revised the BOXED WARNING and WARNINGS sections of the Prescribing Information, the Medication Guide and Patient Agreement to inform healthcare professionals of four cases of septic deaths in the United States, all reported from California, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection. All providers of medical abortion and their patients need to be aware of the risks of sepsis.

[July 19, 2005 - Public Health Advisory - FDA]
[July 19, 2005 - Drug Information Page - FDA]
[July 19, 2005 - Questions and Answers - FDA]
[July 19, 2005 - Letter - Danco Laboratories]
[July 19, 2005 - Label - Danco Laboratories]