Benefit-Risk Assessment of Off-Label Drug Use in Children: The Bravo Framework.

ABSTRACT: A drug is granted a license for use after a thorough assessment of risks and benefits based on high-quality scientific proof of its efficacy and safety. Many drugs that are relevant to children are not licensed for use in this population implying that a thorough assessment of risks and benefits in the pediatric population has not been made at all, implying a negative risk-benefit balance in children, or implying insufficient information to establish the risk-benefit balance. Use of drugs without positive assessment of risks and benefits exposes children to potential lack of efficacy, unknown toxicity, and harm. To aid guideline committees and individual prescribers, we here present a tutorial of the Benefit and Risk Assessment for Off-label use (BRAvO) decision framework. This pragmatic fr

SUBMITTER: van der Zanden TM 

PROVIDER: S-EPMC8518427 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature