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Article History

Received: 24 November 2022

Accepted: 16 March 2023

First Online: 31 March 2023

Declarations

:

: The study conducted is a retrospective analysis, which is not subject to the advisory duty of the ethics comittee.(see ). This was confirmed by the local ethics committee of the Medical Faculty of Bonn (009/17). Thus, for this study, informed consent was not applicable. No surveys or examinations were carried out on patients. The analysed data is routinely collected, and stored in the adverse drug reaction database EudraVigilance from the European Medicines Agency (EMA). Among others, pharmaceutical companies, physicians or pharmacists are obliged to forward respectively report adverse drug reactions (reporting channels see Dubrall et al., 2018 (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 analyse EudraVigilance data in order to fulfill its pharmacovigilance obligations. The study was conducted in accordance with the Declaration of Helsinki (2013).

: Not applicable.

: The authors declare that they have no competing interests.