FDA considers meeting on Mifeprex

Agency is discussing holding a workshop on Clostridium sordellii after determining that four women who died from sepsis following use of Danco's abortifacient Mifeprex (mifepristone) tested positive for the bacteria. FDA notes that tests of lots of mifepristone (also known as RU-486) and misoprostol (which is used in conjunction with Mifeprex) were negative for contamination. Agency issued a public health advisory July 19 concerning the sepsis deaths (1"The Pink Sheet" July 25, 2005, p. 4)...

Agency is discussing holding a workshop on Clostridium sordellii after determining that four women who died from sepsis following use of Danco's abortifacient Mifeprex (mifepristone) tested positive for the bacteria. FDA notes that tests of lots of mifepristone (also known as RU-486) and misoprostol (which is used in conjunction with Mifeprex) were negative for contamination. Agency issued a public health advisory July 19 concerning the sepsis deaths (¹ (Also see "Crawford’s First Business After Confirmation: Brief Senators On Mifeprex" - Pink Sheet, 25 Jul, 2005.), p. 4)....