Document is current

Article History

Accepted: 17 August 2022

First Online: 16 September 2022

Declarations

:

: No funding was received for the conduct of this research or the preparation of this article.

: The authors declare that they have no potential conflicts of interest that might be relevant to the content of this article.

: Ethics approval was not considered necessary for this study because of the nature of the study, which is a retrospective analysis of reports registered in the Italian pharmacovigilance database coming from the Calabria region over 10-year period. Minimal personal data were collected and were codified in order to guarantee confidentiality.

: Not applicable. Patient consent was waived because of the type of study, being a retrospective analysis, and no patient interviews were required.

: All the authors give the publisher license of the copyright which provides the publisher with the exclusive right to publish and sell the research findings.

: The datasets for this manuscript are not publicly available because pharmacovigilance data in a single non-aggregated form are available only under a specific authorization released by the Italian Medicines Agency, which is the custodian of data stored in the RNF database. Requests to access the datasets should be directed to the Italian Medicines Agency.

: The RNF codes were used in order to guarantee confidentiality.

: CL and GDS contributed to the development and formulation of the research question. BP performed the data extraction. CL, CDS, CP, and IC performed the data analysis, with assistance from the other authors. All authors contributed to the interpretation of the results. The manuscript was primarily written by CL, and it was revised and edited by RC and GDS. All authors have read and approved the final version of the manuscript.