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Article History

Received: 7 March 2025

Accepted: 24 March 2026

First Online: 2 June 2026

Declarations

Conflicts of interest: XM has received financial support from Allergan-Abbvie, Amgen-Horizon, Aptyspharma, Biogen, BMS, Grünenthal, Lilly, Lundbeck, Teva, Merck-Serono, Novartis, Orion, Pfizer, Roche, Sanofi-Genzyme and Sun Pharma and non-financial support from Dr Reddy’s and SOS Oxygène not related to the submitted work. All other co-authors have no competing interests to disclose.

Ethics approval: Ethical approval for the EUROmediCAT database was provided by the Ulster University Nursing Research Governance Filter Committee. The EFEMERIS cohort was approved by the French Data Protection Agency on 7 April, 2005 (authorization number 05-1140). All contributing registries have their own ethics approval arrangements appropriate to their national and local ethics guidelines, and gave approval for their data to be used in this study. This study was performed on anonymized patient data.

Consent to participate: All data in EUROmediCAT are anonymized; therefore, patient informed consent for this particular study was not required. The women included in EFEMERIS database were informed of their inclusion and of the potential use of their anonymized data for research purposes. They can oppose the use of their data at any time.

Consent for publication: No specific consent for this publication was obtained from women.

Availability of data and material:: EUROmediCAT encourages the use of its data and networks for pharmacovigilance and medication safety research. Individual data are only available to consortium members; however, EUROmediCAT can be commissioned to do a study, or engage in a collaborative study. Requests can be made at .

Code availability:: The study protocol was registered in the EUPAS Registry (EUPAS43385) and is available from the zenodo repository: [ ]

Author contributions:: The study was primarily conceived and designed by ABB and CDM. ML provided access to the EUROmediCAT Central Database. M-C A, JB, AC, EG, MG, JH, EDH, A L-B, NL, and MM reviewed and confirmed exposure and congenital anomalies classification of their exposed cases. EG and ML reviewed the congenital anomalies classification and provided input in the case series description. The data curation and statistical analyses were performed by ECC. ABB and ECC drafted the manuscript and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.