E-drug: Poorly treated infantile diarrhoea (cont'd)
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A few years ago I conducted a survey of the information on infant
antidiarrhoeal products in the monographs published in the
Compendium of Pharmaceuticals and Specialties (the Canadian
equivalent of the PDR). The article was published in the Canadian
Family Physician 1994;40:2082-7. Below is the abstract of the article.
Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone: (416)-964-7186
Fax: (416)-923-9515
e mail: joel.lexchin@utoronto.ca
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Objective: To review information on the safety and effectiveness of
medications used in the treatment of acute infectious diarrhoea in
children that is supplied by the companies marketing these drugs.
Design: Survey type.
Data Sources: Drugs were identified through a manual search of the
Compendium of Pharmaceuticals and Specialties. Companies making
these drugs were sent a letter asking for the following information:
1. The company's best evidence that its product is both safe and
effective for the treatment of diarrhoea in children?
2. Any information the company had on adverse effects in
Canadian children related to the use of its product.
Data Extraction: Product monographs in the CPS were reviewed for
the following information: availability (by prescription or
over-the-counter), mention of oral rehydration therapy, age (weight)
limit for use and safety information. Information in the monographs
was compared for completeness to that in a report from the World
Health Organization and/or AMA Drug Evaluations Annual 1991.
Results: Four companies market a total of six products. Only the
monograph for loperamide (Imodium) specifically mentions rehydration
therapy. Safety information in the monographs for loperamide and
diphenoxylate (Lomotil) was comparable to that in the WHO report.
The safety information about attapulgite (Kaopectate), kaolin and
pectin was limited as was the information about belladonna alkaloids
and paregoric compound (Donnagel, Donnagel-PG and Donnagel-MB).
None of the companies could provide well-controlled scientific studies
showing that their products are effective in the treatment of acute
infectious diarrhoea in children.
Conclusions: If these products remain on the Canadian market, then
the companies making them should cease to list them as indicated in
acute infectious diarrhoea in children. All company supplied literature
should unequivocally state that ORT is the prime therapeutic modality
for this condition. The safety information supplied for Kaopectate and
all forms of Donnagel needs to be upgraded.
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