Arrhythmias related to antipsychotics and antidepressants: an analysis of the summaries of product characteristics of or
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PHARMACOEPIDEMIOLOGY AND PRESCRIPTION
Arrhythmias related to antipsychotics and antidepressants: an analysis of the summaries of product characteristics of original products approved in Germany Mohamed Elsayed 1 & Emaad Abdel-kahaar 2,3 & Maximilian Gahr 1 & Bernhard J. Connemann 1 & Michael Denkinger 4,5 & Carlos Schönfeldt-Lecuona 1 Received: 11 June 2020 / Accepted: 17 November 2020 # The Author(s) 2020
Abstract 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. Keywords Arrhythmias . SmPCs . QTc prolongation . Sudden cardiac death . Psychiatric drug
Introduction Cardiac adverse events (CAE) can potentially arise from both psychiatric and non-psychiatric drugs [1]. They range from * Mohamed Elsayed [email protected] 1
Department of Psychiatry and Psychotherapy III, University of Ulm, Leimgrubenweg 12-14, 89075 Ulm, Germany
2
Institute of Pharmacology of Natural Products and Clinical Pharmacology, University of Ulm, Ulm, Germany
3
Department of Pharmacology, Qena Faculty of Medicine, South Valley University, Qena, Egypt
4
Agaplesion Bethesda Clinic, Geriatric Research Unit Ulm University, Ulm, Germany
5
Geriatric Center Ulm/Alb-Donau, Ulm, Germany
tachycardia to potentially lethal ventricular arrhythmias, sudden cardiac arrest, and sudden cardiac death [1]. In psychiatry, much attention has been paid to evaluate the risk of psychiatric drugs of all substance groups to cause arrhythmias and to describe drug-induced disturba
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