The FDA and Danco Laboratories have revised the boxed warning and warnings sections of the labeling for mifepristone (Mifeprex) to warn healthcare providers about four cases of septic deaths from September 2003 to June 2005 in women following medical abortion with mifepristone and misoprostol.
The presentation of these cases was not typical, the FDA noted. Healthcare providers are advised to instruct patients to contact them if they develop weakness, nausea, vomiting, or diarrhea with or without abdominal pain and fever, more than 24 hours after taking misoprostol. These symptoms, even in the absence of fever, may indicate sepsis.