Researchers, Physicians Discuss Potential Causes Of C. Sordellii Infections, Safety Of Mifepristone, Misoprostol, Ahead Of Federal Meeting

Main Category: Abortion
Article Date: 15 May 2006 - 3:00 PDT

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Researchers and physicians have been discussing the potential causes of infection with the rare and deadly bacterium Clostridium sordellii and the safety of the medical abortion drugs mifepristone and misoprostol ahead of a public meeting on Thursday in Atlanta organized by CDC, FDA and the National Institute of Allergy and Infectious Diseases, the AP/Minneapolis Star Tribune reports (Bridges, AP/Minneapolis Star Tribune, 5/10). FDA in July 2005 after the deaths of four California women who took Danco Laboratories' Mifeprex -- known generically as mifepristone -- issued a public health advisory warning physicians to watch for any signs of sepsis or other infections among women taking the drug. 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 C. sordellii. However, the researchers found no direct link among the deaths of the women and concluded that the risk of infection in conjunction with taking the drug is "low." FDA in March reported that two other 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. Last month, the agency announced that Mifeprex 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 had been cleared (Kaiser Daily Women's Health Policy Report, 5/8).

Other Cases of C. Sordellii Infection
Researchers in NEJM in December 2005 and in April published studies and letters linking C. sordellii infection to the deaths of eight women who had recently delivered infants either vaginally or by caesarean section, two women who had miscarriages and one woman who was infected during her menstrual period, according to the AP/Star Tribune. Clostridium bacteria live in the vaginas of about 4% to 10% of all women, and about 1% of those bacteria are C. sordellii, which means that about one in 1,000 women could be living with the bacterium, the AP/Star Tribune reports. Beverly Winikoff, a physician and women's health advocate, said some physicians believe placental or fetal tissue that remains in the vagina after abortion, miscarriage or delivery of an infant could provide a place for C. sordellii to replicate. "That's a critical question: Is this association between use of Mifeprex and infection with C. sordellii ... or is it something more general?" Susan Wood, former FDA assistant commissioner for women's health, said, adding that she thinks the connection is more general (AP/Minneapolis Star Tribune, 5/10).

Vaginal Misoprostol Use
The four California women who died administered misoprostol vaginally, which is not an FDA-approved method, and some researchers say vaginal insertion could cause C. sordellii infection, the New York Times reports. "The tablets are small, and women don't necessarily know where their vagina begins and ends," Phillip Stubbefield, an ob-gyn professor at Boston University, said, adding that women could drag the pill along their perineum, between the vagina and rectum, which could bring bacteria into the vagina (Harris, New York Times, 5/11). The Planned Parenthood Federation of America in March announced in a statement that it no longer will recommend that patients administer misoprostol vaginally (Kaiser Daily Women's Health Policy Report, 3/20). Mitchell Creinin, director of family planning at the University of Pittsburgh, said he disagrees with the vaginal-insertion theory and will continue to recommend vaginal administration of the drug (New York Times, 5/11). Abortion-rights supporters and opponents plan to attend the meeting on Thursday, in which a panel of experts, mostly from outside the agencies, also plan to discuss outbreaks of another bacterium, C. difficile, in some states, Reuters reports (Heavey, Reuters, 5/11).

Hearing, Legislation on Mifeprex
In related news, the House Reform Committee's Subcommittee on Criminal Justice, Drug Policy and Human Resources next week plans to hold a hearing on the safety of the medical abortion drug, LifeNews.com reports (Ertelt, LifeNews.com, 5/10). A Senate bill (S 511) would suspend sales of the drug until the Government Accountability Office reviews the process by which FDA approved its use (AP/Minneapolis Star Tribune, 5/10).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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