Characterization of drug-related oral and dental adverse events

Abstract

Background

Given the high prevalence of prescription drug use in the US population and the possible drug-related oral and dental adverse events (AEs), it is important to characterize drug-related oral and dental AEs from available data sources. The objectives of this study were to identify and characterize various drug-related oral and dental AE pairs reported in the literature and drug labeling.

Types of Studies Reviewed

A systematic descriptive review of the literature was performed after applying the search criteria in PubMed, Embase, and Web of Science. A full-text review of drug labeling was conducted in FDALabel (US Food and Drug Administration) with natural language processing using terms from Medical Dictionary for Regulatory Activities, Version 26.0. Comparative data analysis was performed. Heat maps and tree maps were generated for drug–oral and dental AE pair characterization.

Results

The authors reviewed 505 published articles and 2,663 drug labelings. They identified 180 major drug–oral and dental AE pairs reported in the literature but not found in drug labeling. The drug–oral and dental AE pairs most frequently reported in the literature and listed in drug labeling were oral and dental local hypersensitivity reactions (977), Stevens-Johnson syndrome and toxic epidermal necrolysis (419), mucositis and stomatitis (337), and orofacial clefts (151). With respect to oral and dental AEs in labeling, most warnings and precautions were for drug-induced systemic lupus erythematosus and most boxed warnings were for Stevens-Johnson syndrome and toxic epidermal necrolysis.

Conclusions and Practical Implications

The results of this study advance understanding of major oral and dental AEs across various therapeutic areas captured in the literature and labeling. The authors characterized those drugs and drug classes associated with major labeled oral and dental AEs (ie, requiring labeling in warnings and precautions or boxed warnings). To the authors’ knowledge, such comprehensive descriptive information was not available previously.