Serious Adverse Drug Reactions Associated with Off-Label and Unlicensed Drug Use in Children: A 14-Year Analysis of VigiBase Reports from Serbia
: Although off-label and unlicensed drugs accounted for a minority of pediatric reports, they were associated with a higher proportion of serious reported ADRs, particularly in the neonatal period. These findings should be interpreted as pharmacovigilance reporting patterns rather than incidence-based estimates or proof of causality.
Authors
- Jovana Joksimovic
- Milica Bajčetić (ORCID: https://orcid.org/0000-0002-4564-5238)
- Marija Kukurić (ORCID: https://orcid.org/0009-0007-3636-4470)
- Dusan Mihajlo Spasic (ORCID: https://orcid.org/0009-0005-7855-5182)
Institutions
- University of Belgrade (RS)
- Centar za Promociju Nauke (RS)
- Regulatory Agency for Electronic Communications and Postal Services (RS)
Publication Details
- Journal
- Children
- Published
- 2026-04-12
- DOI
- https://doi.org/10.3390/children13040536
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00