Analysis of Drug-Drug Interaction Labeling Language and Clinical Recommendations for Newly approved Drugs Evaluated With Digoxin, Midazolam, and S-Warfarin


To best promote drug tolerability and efficacy in the clinic, data from drug-drug interaction (DDI) evaluations and subsequent translation of the results to DDI prevention and/or management strategies must be incorporated into the US Food and Drug Administration (FDA) product labeling in a consistent manner because differences in language might result in varied interpretations. This analysis aimed to assess the consistency in DDI labeling language in New Drug Applications (NDAs).