Adverse events associated with drug-related thiamine deficiency: A pharmacovigilance study

Abstract

Background

Thiamine deficiency can cause severe complications, including beriberi, Wernicke's encephalopathy, and Korsakoff syndrome, potentially leading to irreversible neurological damage or death. While causes such as chronic alcohol use disorder are established, drug-induced thiamine deficiency represents a potential risk that is often overlooked. However, systematic data on this association remain limited.

Methods

We utilized relevant preferred terms from the Medical Dictionary for Regulatory Activities to identify adverse events in the United States Food and Drug Administration Adverse Event Reporting System from 2004 through 2024. Signal detection was performed using four algorithms: the reporting odds ratio, the proportional reporting ratio, the information component, and the empirical Bayes geometric mean.

Results

We identified 1,046 cases of thiamine deficiency, showing an increasing trend. Hospitalization was reported in 46.0% of cases. The median patient age was 55.0 years (interquartile range: 41.0–68.0), and 42.5% were female. Healthcare professionals submitted 81.5% of reports, and the United States contributed the largest share (27.8%). The five agents most frequently reported were furosemide, metformin, fedratinib, metronidazole, and fluorouracil. Overall, 38 drugs demonstrated consistently positive safety signals across all four methods. Additional drugs exhibiting notable signals included arsenic trioxide, torasemide, rabeprazole, and hydrochlorothiazide.

Conclusion

This pharmacovigilance analysis identifies safety signals linking specific medications with thiamine deficiency, potentially mediated by mechanisms such as transport inhibition and metabolic interference. These findings highlight the importance of clinical vigilance and the consideration of thiamine monitoring in high-risk patients to mitigate the risk of neurological complications.