FDA, CDC Officials To Meet Next Year To Discuss Mifeprex, Users' Possible Increased Susceptibility To Rare Bacterial Infection

FDA and CDC officials next year are expected to meet to discuss Danco Laboratories' Mifeprex -- known generically as mifepristone, which when taken with misoprostol can cause a medical abortion -- after a rare bacterial infection was linked to the deaths of four California women who took the drug, the New York Times reports (Harris, New York Times, 11/23). FDA in July issued a public health advisory warning physicians to watch for any signs of sepsis or other infections among women taking the drug, which FDA approved in 2000 for the termination of pregnancies of 49 days or less (Kaiser Daily Women's Health Policy Report, 8/15). FDA officials on Nov. 4 updated the warning on the agency's Web site after they discovered all four women were infected with Clostridium sordellii, a rare and deadly bacterium. Believing the infections possibly were tied to California's supply of Mifeprex, FDA tested the drugs but found no trace of contaminants, the Times reports. Experts at the meeting next year are hoping to determine whether patients who take Mifeprex are more likely to develop an infection from Clostridium sordellii and whether such an infection "could be more easily diagnosed and even prevented," an unnamed official said (New York Times, 11/23). According to CDC, the one factor that ties the four cases together is that misoprostol was administered vaginally instead of orally. Vaginal administration of misoprostol is considered "off-label use," which is allowed but not recommended by FDA (Kaiser Daily Women's Health Policy Report, 8/15). It is not yet known if this could contribute to infection with the Clostridium sordellii bacterium. FDA has not said whether it is considering limiting access to Mifeprex; however, the agency is advising doctors against prescribing antibiotics in order to prevent an infection because antibiotic therapy often can be risky for patients. The women's families have filed a lawsuit against Danco, claiming the company did not warn patients of the drug's risks (New York Times, 11/23).


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