Rachwal, Oskar https://orcid.org/0009-0005-9793-4356
Gutiérrez-Lobón, Mar https://orcid.org/0009-0001-2905-2475
Cueto, Nuria Sols https://orcid.org/0009-0009-0436-0242
Ventura, Araceli Nuñez https://orcid.org/0009-0006-4998-214X
Fernández-Fernández, Cristina https://orcid.org/0000-0001-7992-8933
van Hunsel, Florence P. A. M. https://orcid.org/0000-0001-8965-3224
Scholl, Joep H. G. https://orcid.org/0000-0002-9222-5965
Gordillo-Marañón, María https://orcid.org/0000-0003-2993-6577
van Puijenbroek, Eugène P. https://orcid.org/0000-0002-2236-1398
Article History
Received: 4 September 2025
Accepted: 9 December 2025
First Online: 7 January 2026
Declarations
:
: Florence van Hunsel and Eugène van Puijenbroek are Editorial Board members of Drug Safety. These authors were not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. The other authors report no conflict of interest.
: 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 Netherlands Pharmacovigilance centre Lareb and FEDRA data access policy described in . Subject to these conditions, data is available from the authors on reasonable request. Code used in the extraction and analysis of data is available upon reasonable request.
: Ethics approval was not needed for this study.
: Study conception and design: OR, MGL, NSC, ANV, CFF, MGM, EvP and FHL. Data extraction and statistical analysis Lareb data: OR, JS and EvP. Data extraction and statistical analysis Spanish National Database: MGL. Interpretation of results and preparation draft manuscript: all authors. All authors reviewed the results and approved the definitive version of this manuscript.
: Not applicable.
: Not applicable.