Document is current

Article History

Accepted: 10 November 2022

First Online: 5 December 2022

Change Date: 29 March 2023

Change Type: Update

Change Details: The original article has been corrected. Supplementary materials were missing from this article and have now been uploaded.

Declarations

:

: This work is part of Daniele Sartori’s DPhil in Evidence-Based Medicine at the University of Oxford (Nuffield Department of Primary Care Health Sciences and the Department of Continuing Education), UK. The DPhil is fully funded by the UMC.

: JKA has written papers on adverse drug reactions in peer-reviewed journals and has received royalties from textbooks that he has edited or co-edited; he has often acted as an expert witness in cases involving adverse drug reactions, including opioids, most often in Coroners’ courts. DS and GNN are employed by the UMC, which manages VigiBase and holds the archives of the Signal Document used to retrieve part of the included studies. Part of the reviewed materials was published in peer-reviewed journals, drug bulletins, and abstracts or posters by researchers presently or formerly belonging to this foundation. Specifically, DS has authored signals published on drug bulletins, as abstracts or posters, some of which were included in this review, and received funding for doctoral studies from the UMC. IJO has no competing interests.

: This research relied on publicly available, previously collected, anonymized, non-National Health Service data. As such, ethics approval was not required.

: Not applicable.

: Not applicable.

: Original data, including coding of medicinal products and adverse events to standardized dictionaries, will be made available upon request.

: The code used to retrieve the dates of the reports from VigiBase will be made available on reasonable request.

: DS designed the study, with support from IJO, JKA, and specific inputs from GNN. GNN joined the research team later, during data analysis and production of the manuscript, providing support for analysis and substantial contribution to the overall structure of this text. This manuscript was written by DS with support from IJO, GNN, and JKA. All authors read and approved the final manuscript.