Postabortion deaths spur update of Mifeprex label.(News)

Clostridium sordellii has been confirmed as the cause of sepsis in four women who died in the United States following the use of Mifeprex (mifepristone) for medical abortion, the Food and Drug Administration reported.

The product's package insert and a related public health advisory released in July after two of the cases were confirmed to be due to C. sordellii have been updated to reflect the new information. The updates also note that FDA tests of manufacturing lots of mifepristone and misoprostol, which is used along with mifepristone for medical abortion, showed no signs of contamination with the bacteria.

The deaths occurred in California between September 2003 and June 2005. All followed the off-label use of oral mifepristone and vaginal misoprostol given as 200 mg mifepristone orally followed the next day by 800 mcg misoprostol inserted vaginally, rather than the FDA-approved regimen of 600 mg of oral mifepristone followed by 400 mcg of oral misoprostol. An additional death in Canada in 2001 also was linked with C. sordellii infection following medical abortion with the off-label regimen of oral mifepristone followed by vaginal misoprostol.

The absence of any evidence of product contamination with C. sordellii provides support for some experts' belief that mifepristone alters innate immunity, predisposing recipients to potentially lethal infections. This theoretical mechanism of ...