What does FDA know about serious infections reported with Mifeprex use?
Since the approval of Mifeprex in September 2000, FDA has been informed of six deaths in the United States due to serious infections following medical abortion with mifepristone and misoprostol that FDA has concluded may possibly be related to the use of these drugs. These women died from sepsis (serious infection involving the bloodstream). Five cases were found to involve infection with bacteria known as Clostridium sordellii and one case involved infection with Clostridium perfringens. Sepsis is a known risk related to any type of abortion. The symptoms in all of these cases of serious infection were not the usual symptoms of sepsis. We do not know whether using Mifeprex and misoprostol caused these deaths. In all but one case, the misoprostol was used intravaginally. 19. What are Clostridium sordellii and Clostridium perfringens? Clostridium sordellii and Clostridium perfringens are bacteria that are anaerobic (they can live without oxygen) and that in very rare cases can produce t