EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding
The reporting of 922 ADRs in breastfed infants over a decade, compared to the estimated millions of infants exposed to medications via mothers' milk annually in Europe, suggests a very low reporting rate of suspected ADRs. This finding emphasizes the significant challenges in postmarketing surveillance and suggests that underreporting remains a critical concern in pharmacovigilance.
Authors
- Christina Gade (ORCID: https://orcid.org/0000-0002-0007-6158)
- R H Olsen (ORCID: https://orcid.org/0000-0001-8114-365X)
- Jón Trærup Andersen (ORCID: https://orcid.org/0000-0003-0169-1328)
- Henrik Horwitz (ORCID: https://orcid.org/0000-0001-6436-1567)
- Ditte Resendal Gotfredsen (ORCID: https://orcid.org/0000-0001-5835-5726)
- Ulrik Lausten‐Thomsen (ORCID: https://orcid.org/0000-0003-1136-4347)
- Ida M. Heerfordt (ORCID: https://orcid.org/0000-0002-6130-875X)
- Anette Kirstine Stark
Institutions
- Statens Serum Institut (DK)
- University of Copenhagen (DK)
- Frederiksberg Hospital (DK)
- Copenhagen University Hospital (DK)
- Rigshospitalet (DK)
Publication Details
- Journal
- British Journal of Clinical Pharmacology
- Published
- 2025-04-06
- DOI
- https://doi.org/10.1002/bcp.70063
- Citations
- 3
- Primary Topic
- Pregnancy and Medication Impact
- Type
- article
- Field-Weighted Citation Impact
- 5.64