How Drug-Drug Interaction Studies Inform Drug Labeling: A Survey of US FDA-Approved New Molecular Entities from 1998 to 2022.

Analysis of DDI recommendations in FDA drug labeling over 25 years (1998-2022), focus on CYP3A/2C19/2C9

This survey analyzes DDI information in FDA labeling for new molecular entities approved from 1998 to 2022, examining how DDI studies — particularly for CYP3A, CYP2C19, and CYP2C9 pathways — translate into actionable prescriber recommendations. Gaps in consistency and actionability of DDI recommendations are identified across the period.

Synthesis written by Geno'X. For the full original abstract, please refer to the source publication.

A systematic 25-year analysis of FDA DDI labeling reveals inconsistencies with direct implications for prescription safety. This work is valuable for pharmacovigilance teams and pharmacologists seeking to understand how regulatory agencies translate DDI data into information obligations.

Clinical impact: 2/3 · Evidence strength: 2/3 · Novelty: 1/2 · Sample size: 0/1 · Publication status: 1/1 → Total: 6/10