Robiyanto, Robiyanto https://orcid.org/0000-0001-5522-6785
Barrett, Jim W. https://orcid.org/0000-0002-0151-0753
Sandberg, Lovisa https://orcid.org/0000-0001-6982-5244
Raemaekers, Boukje C. https://orcid.org/0009-0008-3946-3340
Norén, G. Niklas https://orcid.org/0000-0002-4595-230X
Schuiling-Veninga, Catharina C. M. https://orcid.org/0000-0002-8527-2608
Hak, Eelko https://orcid.org/0000-0003-0849-7210
van Puijenbroek, Eugène P. https://orcid.org/0000-0002-2236-1398
Article History
Received: 27 June 2025
Accepted: 20 August 2025
First Online: 2 September 2025
Declarations
:
: No funding was received for this study.
: Niklas Norén and Eugène van Puijenbroek are editorial board members of Drug Safety. Neither of these authors were involved in the selection of peer reviewers for the manuscript or any of the subsequent editorial decisions. All other authors have no conflicts to declare.
: Not applicable.
: Not applicable.
: Not applicable.
: The data that support the findings of this study are not publicly available. Access to the data is restricted based on the conditions for access within the WHO Programme for International Drug Monitoring. Subject to these conditions, data are available from the authors on reasonable request.
: Code used in the extraction and analysis of data is available upon reasonable request.
: Study conception and design: RR, EvP, CSV, NN, LS, BR, and JB. Data extraction and statistical analysis of VigiBase data: JB. Case series review: RR and EvP. Interpretation of results and preparation of draft manuscript: RR, EvP, CSV, NN, LS, BR, JB, and EH. All authors reviewed the results and approved the final version of this manuscript.