Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database

ABSTRACT

Background

Drug-induced delirium is known risk factors associated with increased morbidity and mortality in older patients. The objective was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS).

Research design and methods

Delirium reports in older patients (age ≥65) extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional reported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs.

Results

Of the 130,885 reports (including 28,850 delirium events and 1,857 drugs) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system, cardiovascular system , alimentary tract and metabolism and anti-infectives for systemic use. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs, 44.90% (141/314) were possible and 28.98% (91/314) were new potential.

Conclusion

Drug-induced delirium risk is prevalent in older patients, according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.

KEYWORDS:

• Older patients
• drug-induced delirium
• pharmacovigilance
• FARES
• ADEs

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Y Cui and Y Zhou developed the study protocol and research design. B Jia and S Zhou performed the search, processed data, analyzed data, and interpretated data. B Jia and J Li wrote the main manuscript. S Zhou, Y Zhou, and L Wan reviewed and revised the manuscript. Y Cui supervised the study, administrated the project, and revised it critically for important intellectual content. All the authors contributed to the interpretation of data and approved the final version of the manuscript.

Ethical approval

For this type of study, ethical approval is not required.

Informed consent

For this type of study, formal consent is not required.

Data availability statement

The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2357242

Additional information

Funding

This study was supported by grants from the National High-Level Hospital Clinical Research Funding [Scientific Research Seed Fund of Peking University First Hospital No.2022SF87] and Interdepartmental Research Project of Peking University First Hospital [No.2023IR37] and Clinical Pharmacy research project of Beijing Pharmaceutical Society [LCYX-2022-10].