DRUG SAFETY MONITORING OF 12,692 PATIENTS TREATED WITH FLUOXETINE

The safety of new drugs introduced into clinical practice in Britain i s assessed by Prescription-Event Monitoring, a system complimentary to that of the Committee on Safety of Medicines. It is independent of st udies carried out by the pharmaceutical industry. Data on 12692 patien ts treated with fluoxetine under the National Health Service were obta ined from family practitioners throughout England. The main outcome me asures were the rate of recorded events per 1000 patients during the f irst month of treatment and the mean rate of events during the followi ng 5 months. The rates were compared with those for other selective se rotonin reuptake inhibitors elicited by Prescription-Event Monitoring. Individual events, documented in the literature as unwanted effects o f fluoxetine and other antidepressants and reported in the present stu dy, were assessed with the help of information provided by the practit ioners. All pregnancies were followed up to determine their outcome. C auses of death were established from patients' medical records and dea th certificates. Neuropsychiatric symptoms were the most frequently re ported events, while the most commonly reported individual event was n ausea. The rate of several events increased with increasing age. No hi therto unrecognized severe adverse drug-related events were reported. Fluoxetine was considered to be a safe drug, even when prescribed in f amily practice for a wide range of patients, many of them treated with other drugs for concomitant diseases. (C) 1997 by John Wiley & Sons, Ltd.