Abstract

BackgroundAging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). We sought to evaluate the causes and characteristics of ADRs in older Korean adults (≥65 years) in comparison to younger individuals (< 65 years).MethodsOf 37,523 cases reported at a Korean pharmacovigilance center from 2011 to 2018, we reviewed 18,842 ADRs of certain or probable causality on the basis of WHO-UMC criteria. We estimated the number of ADRs per 1000 patients exposed to the major culprit drugs, and incidence rate ratios were obtained to assess high- and low-risk medications in older adults.ResultsIn total, 4152 (22.0%) ADRs were reported for 3437 older adults (mean age, 74.6 years and 57.3% female). Tramadol (rate ratio, 1.32; 95% confidence interval [CI], 1.21–1.44; P < 0.001) and fentanyl (1.49, 1.16–1.92, P = 0.002) posed higher risks of ADRs in the older adults, whereas nonsteroidal anti-inflammatory drugs (NSAIDs) (0.35, 0.30–0.40, P < 0.001) and iodinated contrast media (ICM) (0.82, 0.76–0.89, P < 0.001) posed lower risks. Ratios of serious ADRs to NSAIDs (odds ratio, 2.16; 95% CI, 1.48–3.15; P < 0.001) and ICM (2.09, 1.36–3.21, P = 0.001) were higher in the older adults than in the younger patients. Analgesics primarily elicited cutaneous ADRs in the younger patients and gastrointestinal reactions in the older adults. ICM more commonly led to anaphylaxis in the older adults than the younger patients (3.0% vs. 1.6%, P = 0.019).ConclusionFor early detection of ADRs in older adults, better understanding of differences in the causes and characteristics thereof in comparison to the general population is needed.

Highlights

  • Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs)

  • We found that iodinated contrast media (ICM) and Nonsteroidal anti-inflammatory drug (NSAID) elicited significantly higher rates of serious ADRs in the older adults than in the younger patients

  • We reviewed a large database of ADRs of certain or probable causality documented at a pharmacovigilance center

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Summary

Introduction

Aging populations are often accompanied by comorbidity and polypharmacy, leading to increases in adverse drug reactions (ADRs). Pharmacotherapy plays an essential role in the management of older adult patients, but is often accompanied by unexpected adverse drug reactions (ADRs) [1]. Multiple comorbidities in older adults leads to the use of multiple drugs, a condition known as polypharmacy, which increases the risk for adverse drug-drug interactions [4]. Prescribing drugs to frail older patients can be difficult because of limited evidence on the benefits and risks of medications in the group: medical guidelines on medications are usually based on meta-analyses or randomized clinical trials, which can be biased by the exclusion of older adults, those with comorbidity and polypharmacy [4]. Clinicians should prescribe medications with clear therapeutic goals and consider de-prescribing ineffective medications that pose more risk than benefit to minimize inappropriate medication in older patients susceptible to ADRs [7, 8]

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