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Sepsis Death Reported With Mifepristone – FDA Issues Warnin

Last Tuesday the FDA issued a public health advisory, warning physicians to watch for any signs //of sepsis or other infection among women who have taken Danco Laboratories' Mifeprex -- known generically as mifepristone -- which when taken with misoprostol can cause a medical abortion after four sepsis related deaths were reported among women who took the drug. FDA approved Mifeprex in 2000 for the termination of early pregnancy, defined as 49 or fewer days gestation.

Physicians have identified the bacterium Clostridium sordelli a common germ not usually associated with illness as the cause of two of the four deaths and suspect it as the cause of the other two deaths.

Acting director of FDA's Center for Drug Evaluation and Research, Steven Galson, said it is not clear why the bacteria became fatal in the women. He also said that the four deaths all occurred in women who did not follow FDA-approved instructions for using the drug. According to the directions, women should take both mifepristone and misoprostol orally, but some clinics instruct patients to insert misoprostol vaginally.

In the meantime the FDA has advised doctors to prescribe antibiotics immediately to women who have taken mifepristone and who have symptoms of Clostridium sordelli infection, including nausea, vomiting, diarrhea and weakness.

Danco a drug manufacturing company has said that it will revise the label of Mifeprex so as to warn users of the possibility of bacterial infection and other complications. According to Danco the Mifeprex packaging already includes a warning stating that women who use the drug could experience serious and possibly fatal infections. Danco says it also plans to send a letter to physicians and emergency department directors to inform them of the updated warning and five known deaths -- four of which were sepsis-related -- among users of Mifeprex.

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