Reactions 410 - 18 Jul 1992

Fluvoxamine safety supported bydatabase

Duphar, the manufacturer of ‘Faverin’ (fluvoxamine),has compiled a database of the experience with thisagent in over 24 000 patients. ‘This has affirmed thedrug’s safety . . . and shown it to be an extremely well-tolerated antidepressant.’ The data were gatheredfrom 54 worldwide postmarketing surveillance studiesin which most patients received fluvoxamine50-300 mg/day for 6 weeks.

A representative from Duphar, Dr W Wagner, whoheaded the taskforce which compiled the data,presented findings from the database in France recently.The most common adverse event of fluvoxamine wasnausea with an incidence of 15.7%.

15% of patients withdrew from treatment because ofadverse effects; most of these did so within the first 2weeks of treatment ‘. . . confirming previous clinicalexperience suggesting that side effects withfluvoxamine occur in the initial stages of treatment’.

The incidence of serious adverse effects withfluvoxamine was 2.5% and the overall incidence ofsuicidal behaviour was very low at 0.8%.‘Faverin’ safety supported by database Reactions 410: 3, 18 Jul 1992 800138903

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Reactions 18 Jul 1992 No. 4100114-9954/10/0410-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved