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U.S. Department of Health and Human Services

Safety

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Mifeprex (mifepristone)

Audience: Reproductive healthcare professionals and consumers
[Posted 03/17/2006] The FDA notified healthcare professionals of two additional deaths following medical abortion with mifepristone (Mifeprex).  The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment. In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.

[March 17, 2006 – Public Health Advisory – FDA]
[March 17, 2006 (UPDATE April 10, 2006) - Drug Information Page – FDA]

Previous MedWatch Alerts:
[July 19, 2005]
[November 11, 2004]