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Clostridium sordellii Toxic Shock Syndrome After Medical Abortion
with Mifepristone and Intravaginal Misoprostol --- United States and Canada, 2001--2005
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.
References
Food and Drug Administration. FDA Public Health Advisory: sepsis and medical abortion. Rockville, Maryland: Food and Drug
Administration, Center for Drug Evaluation and Research; 2005. Available at
http://www.fda.gov/cder/drug/advisory/mifeprex.htm.
Sinave C, Le Templier G, Blouin D, Leveille F, Deland E. Toxic shock syndrome due to
Clostridium sordellii: a dramatic postpartum and
postabortion disease. Clin Infect Dis 2002;35:1441--3.
McGregor JA, Soper DE, Lovell G, Todd JK. Maternal deaths associated with
Clostridium sordellii infection. Am J Obstet Gynecol 1989;161:987--95.
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