Health Experts To Examine Risks Of Mifeprex At Public Meeting

Main Category: Abortion
Also Included In: Women's Health / Gynecology
Article Date: 10 May 2006 - 0:00 PDT


A public meeting to be jointly held Thursday in Atlanta by CDC, FDA and the National Institute of Allergy and Infectious Diseases will discuss the bacterium Clostridium sordellii, which has been associated with the deaths of five women who took Danco Laboratories' Mifeprex, the Wall Street Journal reports (Wilde Mathews/McKay, Wall Street Journal, 5/8). FDA in July 2005 after the deaths of four women who took Mifeprex -- known generically as mifepristone, which when taken with misoprostol can cause a medical abortion -- 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 C. sordellii, but the researchers found no direct link among the deaths of the 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. 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. FDA last month 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, 4/11). Scientific panels at the meeting are expected to discuss C. sordellii but not potential regulatory actions for Mifeprex, according to the Journal. Danco said the company plans to be represented at the meeting, adding that Mifeprex has had a "very low rate of infection" among the approximately 575,000 women in the U.S. who have taken the drug, that there is no evidence of contamination in mifepristone and that there is no evidence that the vaginal insertion of misoprostol leads to a higher risk of infection (Wall Street Journal, 5/8).

"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.

• Additional
• References
• Citations