Why the study?
Most psychiatric drugs, including antidepressants and antipsychotics, may cause cardiac adverse events, prompting an evaluation of their likelihood based on summaries of product characteristics.
What is the frequency of cardiac adverse events reported in the summaries of product characteristics of antidepressants and antipsychotics approved in Germany?
What is the frequency of cardiac adverse events reported in the summaries of product characteristics of antidepressants and antipsychotics approved in Germany?
Based on product characteristics in Germany, antipsychotics generally have more reported cardiac adverse events than antidepressants, with specific drugs like sertindole, sertraline, and venlafaxine carrying higher reported risks for arrhythmias.
SmPC data flag higher arrhythmia risk with select antipsychotics; leaves open real-world incidence and needs prospective validation.
PURPOSE: Most psychiatric drugs, such as antidepressants (AD) and antipsychotics (AP), may cause cardiac adverse events (CAE). We used summaries of product characteristics (SmPC) for assessing the likelihood of AD and AP to cause CAE. METHODS: We identified all original medicinal products (OMP) of AD and AP approved in Germany. We searched for their SmPCs using the online services of PharmaNet.Bund, Gelbe liste®, Rote Liste®, Fachinfo-Service®, and via manufacturer contact. We extracted frequencies of reported CAE (QT prolongation, Torsade de Pointes tachycardia, and ventricular arrhythmia) and performed a risk assessment. RESULTS: We obtained the SmPCs of 24 AD and 26 AP identified as OMP. Comparably high reported frequencies regarding QT prolongation were found for Invega® (paliperidone), Serdolect® (sertindole) (≥ 1/100 and < 1/10), and Zoloft® (sertraline) (≥ 1/10.000 and < 1/1000); regarding Torsade de Pointes tachycardia were found for Serdolect® (≥ 1/1000 to < 1/100), Zoloft®, and Trevilor® (venlafaxine) (≥ 1/10.000 and < 1/1000); regarding ventricular tachycardia for Solian® (amisulpride), Xomolix® (droperidol), Zyprexa® (olanzapine), and Trevilor® (≥ 1/10.000 and < 1/1000). CONCLUSION: The risk and frequency of CAE, as reported in the SmPCs, varied significantly among substances and between groups. There are more reports for AP than AD. The AP with the most frequently reported CAE (QT prolongation and Torsade de Pointes tachycardia) was Serdolect®; for AD, Zoloft® (QT prolongation, Torsade de Pointes tachycardia) and Trevilor® (Torsade de Pointes tachycardia and ventricular tachycardia) carried a higher cardiac risk.
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Elsayed et al. (2020) studied this question.
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