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Article History

Received: 12 November 2025

Accepted: 25 December 2025

First Online: 22 January 2026

Declarations

:

: The ethics committee of the Ärztekammer Nordrhein waived the need for approval since this is not required for retrospective analyses based of pseudonymized spontaneous reports. For this study, informed consent to participate was not applicable. No surveys or examinations were carried out on patients. The analyzed data is routinely collected and stored in the adverse drug reaction database EudraVigilance from the European Medicines Agency (EMA). Among others, pharmaceutical companies, physicians, pharmacists and patients report these ADRs (information concerning the reporting channels see Dubrall et al.   (25)). Further information concerning the processing of personal data in the context of the operation of EudraVigilance Human can be found in the European Medicines Agency’s Data Protection Notice for EudraVigilance Human ( - human-ev_en.pdf). The Federal Institute for Drugs and Medical Devices (BfArM) as a national competent authority is granted with the highest level of access to EudraVigilance since one of the core duties of the BfArM is to analyze EudraVigilance data to fulfill its pharmacovigilance obligations.

: Not applicable.

: Not applicable.

: DD and MS are supported by the EVAS project, which is founded by the Federal Institute for Drugs and Medical Devices and the Institute for Medical Biometry, Informatics and Epidemiology at the university hospital Bonn. PC was funded by the Innovationsfonds project PSY-KOMO.

: The information and views set out in this manuscript are those of the authors and do not necessarily reflect the official opinion of the Federal Institute for Drugs and Medical Devices.