Introduction: Untreated or inadequately treated depression is the largest risk factor for suicide. However, treatment with different antidepressants can have considerable adverse effects, including the increase of the frequency of suicidal thoughts and behavior. This review summarizes the frequency and severity of adverse events observed during the treatment of depression with duloxetine and considers their relevance to clinical practice.
Areas covered: A comprehensive review of the literature was conducted using PubMed and Medline databases listing data published until December 2010. Articles describing safety and tolerability of duloxetine were selected and reference lists of these articles were scrutinized for further relevant papers. In addition, US and EU Summaries of Product Characteristics were studied.
Expert opinion: Treatment with duloxetine was associated with mild to moderate adverse events; sexual dysfunction, nausea, headache, dry mouth, somnolence and dizziness being the most frequent among them. No increase in death from suicide and suicidal thoughts and behavior were detected as compared to placebo. So as to avoid discontinuation syndrome as a consequence of abrupt withdrawal of duloxetine, 2 weeks tapering has been recommended before discontinuation. Overall, duloxetine was found to be well tolerated and can be safely administered even in older patients and in those with concomitant illnesses.