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Titolo:
DRUG SAFETY MONITORING OF 12,692 PATIENTS TREATED WITH FLUOXETINE
Autore:
EDWARDS JG; INMAN WHW; WILTON L; PEARCE GL; KUBOTA K;
Indirizzi:
UNIV SOUTHAMPTON,ROYAL S HANTS HOSP,FAC MED HLTH & BIOL SCI,DEPT PSYCHIAT SOUTHAMPTON SO14 0YG HANTS ENGLAND DRUG SAFETY RES UNIT SOUTHAMPTON SO31 1AA HANTS ENGLAND UNIV TOKYO,FAC MED,DEPT PHARMACOEPIDEMIOL,BUNKYO KU TOKYO 113 JAPAN
Titolo Testata:
Human psychopharmacology
fascicolo: 2, volume: 12, anno: 1997,
pagine: 127 - 137
SICI:
0885-6222(1997)12:2<127:DSMO1P>2.0.ZU;2-E
Fonte:
ISI
Lingua:
ENG
Soggetto:
SUICIDAL IDEATION; HAIR LOSS; SEXUAL DYSFUNCTION; ANTI-DEPRESSANT; UNITED-KINGDOM; HYPERSENSITIVITY; FLUVOXAMINE; ZIMELIDINE; SEROTONIN; EMERGENCE;
Keywords:
PRESCRIPTION-EVENT MONITORING; FLUOXETINE; FLUVOXAMINE; PAROXETINE; UNWANTED EFFECTS; AGE-RELATED EFFECTS; AGGRESSION; SUICIDE; TERATOGENIC EFFECTS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
46
Recensione:
Indirizzi per estratti:
Citazione:
J.G. Edwards et al., "DRUG SAFETY MONITORING OF 12,692 PATIENTS TREATED WITH FLUOXETINE", Human psychopharmacology, 12(2), 1997, pp. 127-137

Abstract

The safety of new drugs introduced into clinical practice in Britain is assessed by Prescription-Event Monitoring, a system complimentary to that of the Committee on Safety of Medicines. It is independent of studies carried out by the pharmaceutical industry. Data on 12692 patients treated with fluoxetine under the National Health Service were obtained from family practitioners throughout England. The main outcome measures were the rate of recorded events per 1000 patients during the first month of treatment and the mean rate of events during the following 5 months. The rates were compared with those for other selective serotonin reuptake inhibitors elicited by Prescription-Event Monitoring. Individual events, documented in the literature as unwanted effects of fluoxetine and other antidepressants and reported in the present study, were assessed with the help of information provided by the practitioners. All pregnancies were followed up to determine their outcome. Causes of death were established from patients' medical records and death certificates. Neuropsychiatric symptoms were the most frequently reported events, while the most commonly reported individual event was nausea. The rate of several events increased with increasing age. No hitherto unrecognized severe adverse drug-related events were reported. Fluoxetine was considered to be a safe drug, even when prescribed in family practice for a wide range of patients, many of them treated with other drugs for concomitant diseases. (C) 1997 by John Wiley & Sons,Ltd.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 02/07/20 alle ore 21:28:41