Arzneimittelsicherheit in der Psychiatrie

Abstract

We evaluated the severe and new adverse drug reactions (ADRs) of the racemic agent citalopram compared to its enantioselective agent escitalopram. This comparison is based on data of the AMSP (Arzneimittelsicherheit in der Psychiatrie) study, which is a drug safety programme for the continuous assessment of severe ADRs in psychiatric inpatients under the routine clinical conditions of treatment. For the systematic comparison of citalopram with escitalopram we performed an analysis of incidence rates concerning severe ADRs. From 2002 to 2006, there is no statistically significant difference between the sums of possible, probable and definite cases of severe ADRs of citalopram (72 cases, incidence rate 1,08 %, 95% confidence interval [[0,83 to 1,33]) compared to escitalopram (71 cases, incidence rate 1,1 %, 95% confidence interval [0,84 to 1,33]). Furthermore, we matched the incidence of single severe ADRs of both agents. This comparison shows no clinical relevant differences. Cases of severe ADRs such as toxic delirium, parkinsonism and other tardive dyskinesia, serotonin syndrome, grand mal seizures, increased liver enzymes, allergic reactions, bleedings, sexual dysfunction, and hyponatremia have been reported for both agents.