Food and Drug Administration.Office of Training and Communications, Division of Drug Information, HFD -240 Center for Drug Evaluation and Research. Guidance for industry. Adverse reactions section of labeling for human prescription drug and biological products—content and format. January2006. www.fda.gov/cder/guidance/5537fnl.htm (accessed 2006 Jan 20).
2.
MiechRP. Pathophysiology of mifepristone-induced septic shock due to Clostridium sordellii.Ann Pharmacother2005; 39: 1483–8. Epub 26 Jul 2005. DOI 10.1345/aph.1G189
3.
Open letter to health care providers (“Dear Doctor Letter”). April 19, 2002. New York, NY: Danco Laboratories.
4.
Medwatch Adverse Event Reports. Individual Safety Report no. 3943786–2. Rockville, MD: Office of Postmarketing Drug Risk Assessment, Food and Drug Administration.
5.
FischerM, BhatnagarJ, GuarnerJ.Fatal toxic shock syndrome associated with Clostridium sordellii after medical abortion. N Engl J Med2005;353:2352–60.
