Government Calls For Conference To Look At Bacterium That Caused Deaths Of Four California Women Who Took Mifeprex

The federal government has called for a conference to look at the Clostridium sordellii bacterium, which caused the deaths of four California women who were taking Danco Laboratories' Mifeprex, the New York Times reports (Harris, New York Times, 2/11). Mifeprex -- which is known generically as mifepristone -- when taken with misoprostol, can cause a medical abortion. FDA in July 2005 issued a public health advisory warning for physicians to watch for any signs of sepsis or other infections among women taking the drug, which the agency approved in 2000 for the termination of pregnancies of 49 days or less. FDA officials on Nov. 4, 2005 updated the advisory after they discovered that the deaths of four California women who took the drug all were caused by C. sordellii, a rare and deadly bacterium. According to a report published in December 2005 in the New England Journal of Medicine, the deaths of the women were linked to toxic shock caused by the bacterium, but the researchers found no direct link among the deaths of the four women and concluded that the risk of infection in conjunction with taking the drug is "low." CDC has said the one factor that ties the four cases together is that misoprostol was administered vaginally instead of orally, which is considered "off-label use" (Kaiser Daily Women's Health Policy Report, 12/8/05). According to the Times, "another intriguing mystery" is that all four cases happened in California. An FDA official speaking on the condition of anonymity said 15 to 20 scientists have been asked to present their research on the bacterium at a May 11 conference at CDC in Atlanta. "We hope to keep the focus on the science," the official said, adding that officials are worried the debate over medical abortion might hinder the scientific discussion. He said, "We're holding this in a secure government facility for a reason" (New York Times, 2/11).


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