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Prescription-Event Monitoring of 10401 Patients Treated with Fluvoxamine

Published online by Cambridge University Press:  02 January 2018

J. Guy Edwards ,
William H. W. Inman ,
Lynda Wilton  and
Gillian L. Pearce
J. Guy Edwards*
Affiliation:
University Department of Psychiatry, Royal South Hants Hospital, Southampton SO9 4PE
William H. W. Inman
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Southampton SO3 8BA, UK
Lynda Wilton
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Southampton SO3 8BA, UK
Gillian L. Pearce
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Southampton SO3 8BA, UK
*
∗Correspondence
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Abstract

Prescription-event monitoring (PEM) is one of two national systems of drug safety monitoring practised in Britain. The objective of this PEM study was to assess the safety of fluvoxamine and to monitor the occurrence of untoward and other events during treatment. A total of 10 401 patients treated with the drug in general practices throughout England were studied and data were analysed in the Drug Safety Research Unit, Southampton. The main outcome measures were the overall incidence of events per 1000 patients; the incidence during the first month of treatment; the mean incidence for months 2–6 of treatment; and the ratio of these rates as a signal that an event could be drug related. The most commonly reported category of events was neuropsychiatric while the most commonly reported individual events were nausea and vomiting. Fluvoxamine was shown to be a safe drug and no unexpected or previously undetected drug-related events were encountered. There was a relatively high incidence of gastro-intestinal symptoms, but other adverse reactions often encountered during treatment with tricyclic antidepressants were not frequently reported.

Type
Peer Review
Information
The British Journal of Psychiatry , Volume 164 , Issue 3 , March 1994 , pp. 387 - 395
Copyright
Copyright © 1994 The Royal College of Psychiatrists 

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