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Adverse effects associated with the use of donepezil in general practice in EnglandDrug Safety Research Unit, Bursledon Hall, Southampton, UK; Department of Primary Medical Care Aldermoor Health Centre Aldermoor Close Southampton SO16 5ST UK; nick.dunn{at}soton.ac.uk
Drug Safety Research Unit, Bursledon Hall, Southampton, UK Donepezil is an acetylcholinesterase inhibitor indicated for the symptomatic treatment of mild to moderate Alzheimer's disease. It is reported to have a relatively favourable side-effect profile. We report here on a pharmacovigilance study carried out post-marketing in England. An observational cohort study using the technique of Prescription-Event Monitoring was carried out. Some 1762 patients (mean age 72.9 years; 42% male) were followed up for 6 months minimum. The commonest adverse events were nausea, diarrhoea, malaise, dizziness and insomnia. Aggression, agitation and abnormal dreams were uncommonly associated with the drug. There were no cardiac rhythm disturbances or liver disorders causally associated. The commonest adverse drug reactions are already reported in the product information. Given the relatively small size of this cohort, the signals of abnormal dreams and psychiatric disturbance as possible adverse drug reactions need further investigation in carefully planned studies.
Key Words: abnormal dreams • aggression • donepezil • pharmacovigilance • prescription-monitoring
Journal of Psychopharmacology, Vol. 14, No. 4,
406-408 (2000) This article has been cited by other articles:
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