FLUVOXAMINE - A REVIEW OF ITS SAFETY PROFILE IN WORLDWIDE STUDIES

Fluvoxamine, a selective serotonin reuptake inhibitor, was studied ext ensively in 34 587 predominantly depressed patients in 66 studies cond ucted world-wide. These studies were largely uncontrolled trials repre senting the use of fluvoxamine by psychiatric and general practice phy sicians in everyday conditions. The safety data were analyzed accordin g to standardized medical review and data management policies. Approxi mately 70% of the fluvoxamine population were female and 44% were aged 31-51 years. The modal total daily dose was 100 mg. Safety findings r evealed a pharmacological adverse event profile similar to that seen w ith other serotonin reuptake inhibitors. Nausea was found to be the on ly common symptom, with an incidence rate of 16%. Approximately 2% of the fluvoxamine population reported at least one serious adverse event (per FDA criteria). Overall suicidality rates of fluvoxamine were fou nd to be low (0.7%). No cases of zimelidine syndrome, bleeding syndrom e or Guillain-Barre syndrome were identified. Overall, fluvoxamine was found to be safe and well tolerated suggesting a favorable alternativ e in the treatment of depression.