A fifth death associated with infection after mifepristone treatment, reported to the the U.S. Food and Drug Administration (FDA) in March 2006, has been linked to a similar bacterium, Clostridium perfringens.
FDA issues health advisory regarding mifepristone and misoprostol
On July 19, 2005, the FDA issued a public health advisory about the deaths of the four U.S. women (two in 2003, one in 2004, and one in 2005) after medical abortion with mifepristone and intravaginal misoprostol. The FDA confirmed that two of the women had developed toxic shock syndrome from C. sordellii infection. On November 4, 2005, the FDA confirmed that the other two deaths also were from C. sordellii infection.
C. sordellii infections still a mystery
The Centers for Disease Control and Prevention (CDC) states that it is not known how C. sordellii is spread, either from person-to-person or from the environment to a person. The FDA has tested samples of manufacturing lots of both mifepristone and misoprostol for contamination but has found none. It is known that some women have C. sordellii bacteria present in their intestinal and rectal areas but have no symptoms of infection (called colonization). Interestingly, all four deaths after mifepristone treatment occurred in California, but the FDA does not know if this is significant.
Investigators at the CDC, the National Institutes of Health, and the FDA are coordinating research to better understand the emerging threat posed by C. sordellii infection. They conducted a public workshop on May 11, 2006, titled, “Emerging Clostridial Disease,” at the CDC Conference Center in Atlanta, Georgia. The workshop’s purpose was to discuss the scientific and medical issues and bring together scientific and public health experts to develop a draft research agenda. The workshop will also provide recommendations for detecting cases and monitoring their frequency. A transcript of the workshop will be available by June 11, 2006.
A medical article published online in The Annals of Pharmacotherapy on July 26, 2005, concluded that theoretically, mifepristone impairs the immune system, thus favoring the development of fatal, systemic infection.
Legislation introduced to halt U.S. mifepristone sales
A bill titled “RU-486 Suspension and Review Act of 2005” was introduced in the U.S. Senate (S.511) and House of Representatives (H.R.1079). The bill proposes withdrawing FDA approval and suspending sales of mifepristone while the Government Accountability Office reviews how the FDA approved the pill for marketing in the U.S. Danco Laboratories, maker of Mifeprex, insists the medication is safe.
FDA Congressional testimony about Mifeprex
On May 17, 2006, FDA Deputy Commissioner Janet Woodcock told a U.S. House of Representatives Government Reform subcommittee hearing that she felt the FDA has responded appropriately to reports of deaths related to use of Mifeprex. According to a printed report, she stated, "What we don't know is whether or not medical abortion increases the probability of getting this infection." The subcommittee is questioning the FDA as part of its review of H.R.1079.
Mifeprex labeling information includes risk of infection
The FDA has updated the Prescribing Information, Medication Guide, and Patient Agreement for Mifeprex to contain information about infection with C. sordellii. It advises women who have taken mifepristone and misoprostol for medical abortion to contact a healthcare provider right away if they develop stomach pain or discomfort, have weakness, nausea, vomiting, or diarrhea with or without fever more than 24 hours after taking the misoprostol. The FDA also advises women to make sure their healthcare providers know they are undergoing a medical abortion, and warns women not to buy Mifeprex over the Internet.
