Fluoxetine treatment and single psychotropic comedication: is there an increase in adverse event rates?

Abstract

After the market launch of fluoxetine (Flx) in Germany in 1990 several series of drug utilization observation studies were carried out under naturalistic conditions (approximately 19,000 patients). This paper focuses on 3158 patients from neuropsychiatric practices comparing adverse event rates plus additional variables in patient groups treated with Flx monotherapy (n=1571) versus those receiving comedication with a single psychotropic (n=737), or those subgroups receiving a single antidepressant (n=222) or antipsychotic drug (n=128). Compared to the monotherapy group, both the comedicated group as a whole and the antidepressant subgroup did not show significant changes in adverse event rates. The subgroup with antipsychotic comedication revealed somewhat higher adverse event rates; the pattern of adverse events, however, was largely comparable, and extrapyramidal symptoms were reported for only a few isolated cases. Thus, these findings suggest that--under naturalistic conditions--comedication of Flx with psychotropic drugs (a commonly used treatment strategy for various reasons) is feasible and does not generally increase patient risk.