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Drug Safety Monitoring of 12692 Patients Treated with Fluoxetine

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. © 1997 by John Wiley & Sons, Ltd.