Current and former FDA officials on Wednesday during a House Reform Committee's Subcommittee on Criminal Justice, Drug Policy and Human Resources hearing said the agency does not know if use of Danco Laboratories' medical abortion drug Mifeprex increases a woman's risk of becoming infected with the rare and potentially fatal bacterium Clostridium sordellii, the AP/Washington Post reports (Bridges, AP/Washington Post, 5/17). According to a report published in the Dec. 1, 2005, issue of the New England Journal of Medicine, the deaths of four California women who took Mifeprex -- known generically as mifepristone -- along with misoprostol to induce a medical abortion were linked to toxic shock caused by C. sordellii. However, the researchers found no direct link among the deaths of the women and said that the risk of infection in conjunction with taking the drug is low. FDA in July 2005 issued a public health advisory warning physicians to watch for any signs of sepsis or other infections among women taking Mifeprex. The agency in March reported that two other women who took the Mifeprex-misoprostol regimen had died and issued a public health advisory urging physicians and patients to follow approved instructions for the drugs and watch for symptoms warranting medical attention (Kaiser Daily Women's Health Policy Report, 5/17). A fifth death involving use of the medical abortion drugs has been linked to an infection by a similar bacterium, C. perfringens, Reuters reports (Heavey, Reuters, 5/17). Janet Woodcock, the agency's deputy commissioner for operations, said FDA has received reports of 12 deaths that might involve mifepristone use, nine of which were in the U.S. The agency has determined four of the nine deaths are unrelated to use of the drug, CQ HealthBeat reports. One of the women had an undiagnosed ectopic pregnancy, one woman had an unsuccessful medical abortion and an unsuccessful surgical abortion before having a successful surgical abortion, one woman was determined to have died of causes unrelated to mifepristone and misoprostol use and the fourth case is still under investigation, according to Woodcock (CQ HealthBeat, 5/17).

Hearing
FDA has "responded aggressively" to the reports involving the deaths of women who took Mifeprex, Woodcock said, adding, "It is not possible at this time to determine whether the current mifepristone-misoprostol regimen resulted in an increase in C. sordellii infection or whether reporting requirements have uncovered what is an emerging risk in pregnancy overall" (Reuters, 5/17). NEJM in December 2005 and last month published studies and letters from researchers that linked C. sordellii infection to the deaths of eight women who recently had delivered infants either vaginally or by caesarean section, two women who had miscarriages and one woman who was infected during her menstrual period (Kaiser Daily Women's Health Policy Report, 5/17). Subcommittee Chair Mark Souder (R-Ind.) -- who said he organized the hearing to examine whether Mifeprex sets "a low standard for women's health" -- cited 950 reports to FDA of adverse reactions to Mifeprex, including 18 women who received antibiotics and were hospitalized after taking the drug (AP/Washington Post, 5/17). "There is a serious problem with [Mifeprex] and failing to address this problem by disguising it, ignoring it, minimizing it or causing confusion is a shameful failure," Souder said (Rockoff, Baltimore Sun, 5/18). He added that some experts in "immunology, pharmacology and maternal-fetal medicine have suggested that because [Mifeprex] interferes with the innate immune response, the bacteria, if present, is allowed to flourish, causing a widespread, multi-organ infection." Susan Wood, former FDA assistant commissioner for women's health, questioned that theory, saying, "If the immune system were suppressed, we would expect to see a rise in other, more common infections" (CQ HealthBeat, 5/17).

C-SPAN video of the morning and afternoon sessions of the hearing is available online in RealPlayer and Windows Media. The video will be available on the site for 15 days after the event.