Analysis of drug adverse events in elderly patients based on the Japanese Adverse Drug Event Report Database

J Clin Pharm Ther. 2022 Aug;47(8):1264-1269. doi: 10.1111/jcpt.13670. Epub 2022 Apr 25.

Abstract

What is known and objective: Compared with the general adult population, pharmacokinetics and changes in drug responsiveness occur to a greater extent in the elderly. Interactions may occur between drugs used in combination to treat various diseases and may cause adverse events (AEs). We conducted a cross-sectional risk assessment of AEs in elderly patients based on information gathered from Japanese medical practices with the goal of obtaining information that will contribute to optimizing pharmacotherapy.

Methods: The Japanese Adverse Drug Event Report database was used to determine the incidence of AEs in elderly patients (aged 80 years or older) compared with patients aged less than 80 years old by evaluating the reporting odds ratio using the data obtained from reports.

Results and discussion: Hypnotics and anxiolytics, as well as anticoagulants and theophylline, were identified as groups of drugs that warrant special attention in the elderly. Hypnotics and anxiolytics, especially those that are short-acting, tend to cause delirium and geriatric syndromes including falls and fractures. With respect to anticoagulants, no increase in the risk of bleeding was evident and the dose was believed to be properly adjusted; however, there was an increased risk of anemia. Theophylline toxicity tended to occur more frequently in the elderly, suggesting the need for drug monitoring.

What is new and conclusion: Based on these cross-sectional studies, the evaluation of the risk of AEs for drugs commonly used in the elderly based on near real-world information was achieved.

Keywords: adverse drug event; database; direct-acting oral anticoagulants; elderly; hypnotics; sedatives; theophylline.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Anxiety Agents*
  • Anticoagulants
  • Cross-Sectional Studies
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology
  • Humans
  • Hypnotics and Sedatives
  • Japan / epidemiology
  • Theophylline

Substances

  • Anti-Anxiety Agents
  • Anticoagulants
  • Hypnotics and Sedatives
  • Theophylline