Mifeprex FDA Alerts
The FDA Alert(s) below may be specifically about Mifeprex or relate to a group or class of drugs which include Mifeprex (mifepristone).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for mifepristone
Mifeprex (mifepristone) - Mar 17, 2006
Mar 17, 2006
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 (UPDATE April 10, 2006) - Drug Information Page – FDA]
Mifeprex (mifepristone) - Jul 19, 2005
Jul 19, 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]
Mifeprex (mifepristone) - Nov 15, 2004
Nov 15, 2004
Audience: Reproductive healthcare professionals and consumersDanco 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]
Mifeprex (mifepristone) - Apr 17, 2002
Apr 17, 2002
Audience: Obstetricians/Gynecologists and other healthcare professionalsThe following is new safety information about Mifeprex (mifepristone):
[April 17, 2002 Letter - Danco]
[April 17, 2002 Q&A - FDA]