The Safety Profile of Fluvoxamine in Elderly Patients

Abstract

The safety profile of fluvoxamine was assessed in 4843 elderly, mainly depressed patients (65 years or older; range 65 to 97 years) enrolled in worldwide post-marketing studies. This cohort of elderly patients was extracted from a population of 34 587 patients in whom the safety profile of fluvoxamine has been extensively assessed (Wagneret al., 1994). The daily dose of fluvoxamine ranged from less than 50 to 300 mg and the studies were conducted over periods of up to 1 year. The most conservative category was chosen throughout the analysis in situations where more than one category was applicable. Overall, 3250 patients (67·1 per cent) completed the full study period. At least one adverse event was reported by 2228 patients (46·0 per cent), the most frequently affected body systems being the ‘gastrointestinal’ and ‘nervous’ systems, followed by the ‘body as a whole’. Nausea was the most common adverse event. At least one serious adverse event was experienced by 135 patients (2·8 per cent), hospitalization being the most widespread classification (113 patients; 2·3 per cent). The incidence of overall suicidality with fluvoxamine was low. Thus, these findings indicate that fluvoxamine is a well tolerated drug in elderly patients.