Benefit/risk considerations with respect to OTC-descheduling of loperamide.
The main criteria to be considered for releasing an anti-diarrhoeal from a prescription to an OTC-drug are guaranteed quality control, established efficacy and safety and the evaluation off the drug experience on major markets.
Besides the considerable benefits from a socio-economic point off view, the risk for potential inappropriate use of loperamide (CAS 53179-11-6) as self-medication can be minimized by its use being avoided in children of 5 years of age or less (e.g. by making available a solid formulation only), by limiting the treatment duration to 48 h, and by contraindicating the use of the drug in cases of fever (>38oC) and/or blood in the stools.
On the basis of a broad review loperamide can be considered to be efficacious in acute non-specific, acute functional and traveller's diarrhoea.
The agent has a good safety profile of the mentioned restrictions are born in mind.
Loperamide thus satisfied the OTC criteria.
Mots-clés Pascal : Lopéramide, Antidiarrhéique, Automédication, Facteur risque, Prescription médicale, Analyse avantage coût, Economie santé, Etats Unis, Amérique du Nord, Amérique, Royaume Uni, Europe, Médicament vente libre
Mots-clés Pascal anglais : Antidiarrheal agent, Self prescription, Risk factor, Medical prescription, Cost benefit analysis, Health economy, United States, North America, America, United Kingdom, Europe
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 95-0317176
Code Inist : 002B02H. Création : 01/03/1996.