J Lexchin1. 1. Emergency Department, Toronto Hospital.
Abstract
OBJECTIVE: To assess information on the safety and efficacy of medications that could be used to treat children who have acute infectious diarrhea. DESIGN: Survey of product monographs. Companies were asked to supply their best evidence that products were both safe and effective for treating children who have diarrhea and to supply any information on adverse effects among Canadian children related to use of the products. PARTICIPANTS: Companies making drugs identified in the Compendium of Pharmaceuticals and Specialties as used for acute infectious diarrhea. MAIN OUTCOME MEASURES: Product monographs were reviewed for availability (over-the-counter or by prescription), mention of oral rehydration therapy, age (or weight) limit for use, and safety information. Information in the monographs was compared for completeness with a report from the World Health Organization or the American Medical Association's Drug Evaluations Annual. RESULTS: Four companies market a total of six products. Only one monograph specifically mentioned rehydration therapy. Safety information in two monographs was comparable to that in the WHO report. Safety information in two monographs was limited. None of the companies were able to provide placebo-controlled studies showing their products to be effective. CONCLUSIONS: If these products remain on the Canadian market, companies making them should cease to list them as indicated for acute infectious diarrhea among children. All company-supplied literature should unequivocally state that oral rehydration therapy is the best treatment for this condition. Safety information on some of the products should be upgraded.
OBJECTIVE: To assess information on the safety and efficacy of medications that could be used to treat children who have acute infectious diarrhea. DESIGN: Survey of product monographs. Companies were asked to supply their best evidence that products were both safe and effective for treating children who have diarrhea and to supply any information on adverse effects among Canadian children related to use of the products. PARTICIPANTS: Companies making drugs identified in the Compendium of Pharmaceuticals and Specialties as used for acute infectious diarrhea. MAIN OUTCOME MEASURES: Product monographs were reviewed for availability (over-the-counter or by prescription), mention of oral rehydration therapy, age (or weight) limit for use, and safety information. Information in the monographs was compared for completeness with a report from the World Health Organization or the American Medical Association's Drug Evaluations Annual. RESULTS: Four companies market a total of six products. Only one monograph specifically mentioned rehydration therapy. Safety information in two monographs was comparable to that in the WHO report. Safety information in two monographs was limited. None of the companies were able to provide placebo-controlled studies showing their products to be effective. CONCLUSIONS: If these products remain on the Canadian market, companies making them should cease to list them as indicated for acute infectious diarrhea among children. All company-supplied literature should unequivocally state that oral rehydration therapy is the best treatment for this condition. Safety information on some of the products should be upgraded.