Within the drug safety program in psychiatry AMSP (Arzneimittelsicherheit in der Psychiatrie), severe adverse drug reactions (ADRs) in psychiatric inpatients are assessed in the naturalistic setting of routine treatment. Currently, 35 psychiatric hospitals and departments are participating. This paper focuses on severe cardiovascular ADRs due to psychotropic medications. Related to the number of patients surveyed (122,562 from 1993 to 2000), these are rare events (68 cases or 0.055 %). Imputed drug classes for probable cases were antidepressants in 0.03 % and neuroleptics in 0.019 %, but other drugs were also involved. Within the group of antidepressants, the risk for a cardiac ADR depends much on the class: SSRIs were never imputed alone, but tricyclic antidepressants were imputed alone in 0.05 %. In the group of antipsychotics, the lowest rate of cardiac ADRs was found for the group of phenothiazines (0.003 %).
Cardiovascular risk factors elevated the risk for a cardiac ADR from 0.04 % to 0.14 %. Age as an independent factor did not contribute substantially to the risk for a cardiac ADR. The data of the drug safety program in psychiatry allow some estimate of differential risk rates for cardiac ADRs with different psychotropic drug groups. The results of the project can help clinicians select the appropriate drug for patients at risk to develop cardiac ADRs.
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