Assessment of mandatory declaration excipients in pediatric off label prescriptions in Spain.

ABSTRACT: Pediatric patients are at increased risk of exposure to potentially harmful excipients when receiving off-label medicinal products primarily formulated for adults, raising concerns about adverse events. Based on data from a previously published study, this research focuses on the most frequently prescribed off-label medicinal products in order to assess the safety of their excipients. The aim was to identify Excipients of Mandatory Declaration (EMDs) that could pose additional safety risks in individuals under the age of 18. A descriptive, and retrospective observational population-based study in individuals under 18 was developed in the Spanish primary care setting between the years 2004-2005 and 2017-2020. The main data source was proprietary database, with nationwide coverage of prescri

SUBMITTER: Lizano-Diez I 

PROVIDER: S-EPMC12276334 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature