FDA on Monday announced that Danco Laboratories' Mifeprex -- known generically as mifepristone, which when taken with misoprostol can cause a medical abortion -- was not responsible for one of the two recent deaths of women who had taken the drug, but the agency did not specify which case has been cleared, the Baltimore Sun reports (Rockoff, Baltimore Sun, 4/11). FDA in March reported that two women who took the Mifeprex and misoprostol regimen had died, and it issued a public health advisory urging physicians and patients to follow approved instructions for the drug and watch for symptoms warranting medical attention. One of the women appeared to have had symptoms similar to four California women who took the drug and died. The women's deaths were linked to toxic shock caused by Clostridium sordellii, a rare and deadly bacterium. FDA in July 2005 issued a public health advisory warning physicians to watch for any signs of sepsis or other infections among women taking the drug. Agency officials in November 2005 updated the advisory after learning the cause of death of the California women. According to a report published in the Dec. 1, 2005, issue of 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 California 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 an off-label use (Kaiser Daily Women's Health Policy Report, 3/20). "Of the two most recent deaths, ... one has been determined to be unrelated to an abortion or to the use of Mifeprex and misoprostol, and the other, with symptoms of infection, continues to be under investigation," FDA on Monday said in a statement (Reuters, 4/10). "We stand behind the safety profile of the drug, which has been used by approximately 575,000 women in this country since FDA approval in 2000," Cynthia Summers, director of marketing and public affairs at Danco, said (Wall Street Journal, 4/11). CDC, FDA and the National Institute of Allergy and Infectious Diseases on May 11 plan to hold a public meeting in Atlanta to discuss the scientific and medical conditions associated with reports of C. sordellii, as well as infections of a related bacterium, C. difficile, according to an FDA public health advisory (Kaiser Daily Women's Health Policy Report, 3/20).