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FDA Issues RU-486 Warning From: art fougner, md (evsono@pipeline.com) Wed Jul 20 09:21:10 2005 Messages sorted by: [ date ][ thread ][ subject ][ author ] Next message: Anna Meenan, MD: "Re: Our pernicious legal system" Previous message: Robert J. Carpenter, Jr. MD: "Re: Tripple Screen/AFP" FDA Public Health Advisory Sepsis and Medical Abortion The Food and Drug Administration (FDA) is aware of four cases of septic deaths in the United States, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The other two cases are under ongoing investigation by FDA along with the Centers for Disease Control and Prevention, State and local health departments, and the manufacturer of Mifeprex. All cases involve the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection. Although these deaths are reported from California, all providers of medical abortion and their patients need to be aware of the risks of sepsis. As more information becomes available, FDA will alert the public. http://www.fda.gov/cder/drug/advisory/mifeprex.htm -- art fougner, md "If you don't know where you are going, you will wind up somewhere else." Lawrence Peter Berra Next message: Anna Meenan, MD: "Re: Our pernicious legal system" Previous message: Robert J. Carpenter, Jr. MD: "Re: Tripple Screen/AFP"

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