On July 22, this notice was posted as an MMWR
Dispatch on the MMWR website (http://www.cdc.gov/mmwr).
On July 19, 2005, the Food and Drug Administration (FDA) issued a public
health advisory regarding the deaths of four women in the United States after
medical abortions with Mifeprex® (mifepristone, formerly RU-486; Danco
Laboratories, New York, New York) and intravaginal misoprostol.1 Two
of these deaths occurred in 2003, one in 2004, and one in 2005. Two of these
U.S. cases had clinical illness consistent with toxic shock and had evidence
of endometrial infection with Clostridium sordellii,
a gram-positive, toxin-forming anaerobic bacteria. In addition, a fatal case
of C. sordellii toxic shock syndrome after medical
abortion with mifepristone and misoprostol was reported in 2001, in Canada.2 All three cases of C. sordellii infection were notable for lack of fever, and all had refractory hypotension,
multiple effusions, hemoconcentration, and a profound leukocytosis. C. sordellii previously has been described as a cause of
pregnancy-associated toxic shock syndrome.3
Investigation by FDA, CDC, and state and local health departments into
the two most recently identified U.S. deaths after medical abortion is ongoing.
Empiric therapy for patients suspected of having postpartum or postabortion
toxic shock syndrome should include antimicrobials with anaerobic activity
against Clostridium species. Health-care providers
are encouraged to report any cases of postpartum or postabortion toxic shock
syndrome to their state or local health department and to CDC at telephone
800-893-0485. Cases potentially associated with use of mifepristone or misoprostol
should also be reported through the FDA MedWatch system available at http://www.fda.gov/medwatch/index.html or telephone 800-FDA-1088.
Clostridium sordellii. JAMA. 2005;294(15):1894. doi:10.1001/jama.294.15.1894