United States of America - The Food and Drug Administration (FDA) is investigating serious adverse events associated with mifepristone (Mifeprex®) and highlighting the risk of sepsis or blood infection when undergoing medical abortion using mifepristone and misoprostol in a manner not consistent with the approved labelling. There are now four cases of deaths from infection between September 2003 to June 2005 following medical abortion with these drugs.

The bacteria thought to have caused the fatal infections have been identified in two of the cases and the other two cases are under investigation by FDA together with the Centers for Disease Control and Prevention, State and local health departments, and the manufacturer of Mifeprex®. Doctors are urged to have a higher level of suspicion for sepsis in patients. Previously, the FDA has received reports of serious bacterial infection, bleeding, and ectopic pregnancies that have ruptured, and death. Those reports led to the revision of the black box labelling.

Reference: FDA News, P05-43 19 July 2005 on http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm.