Journal Article

Analysis of anticholinergic adverse effects using two large databases: The US Food and Drug Administration Adverse Event Reporting System database and the Japanese Adverse Drug Event Report database

Ishikawa, Yoichi, Nagai, Junko

2021

Overview

Anticholinergic adverse effects (AEs) are a problem for elderly people. This study aimed to answer the following questions. First, is an analysis of anticholinergic AEs using spontaneous adverse drug event databases possible? Second, what is the main drug suspected of inducing anticholinergic AEs in the databases? Third, do database differences yield different results? We used two databases: the US Food and Drug Administration Adverse Event Reporting System database (FAERS) and the Japanese Adverse Drug Event Report database (JADER) recorded from 2004 to 2020. We defined three types of anticholinergic AEs: central nervous system (CNS) AEs, peripheral nervous system (PNS) AEs, and a combination of these AEs. We counted the number of cases and evaluated the ratio of drug-anticholinergic AE pairs between FAERS and JADER. We computed reporting odds ratios (RORs) and assessed the drugs using Beers Criteria®. Constipation was the most reported AE in FAERS. The ratio of drug-anticholinergic AE pairs was statistically significantly larger in FAERS than JADER. Overactive bladder agents were suspected drugs common to both databases. Other drugs differed between the two databases. CNS AEs were associated with antidementia drugs in FAERS and opioids in JADER. In the assessment using Beers Criteria®, signals were detected for almost all drugs. Between the two databases, a significantly higher positive correlation was observed for PNS AEs (correlation coefficient 0.85, P = 0.0001). The ROR was significantly greater in JADER. There are many methods to investigate AEs. This study shows that the analysis of anticholinergic AEs using spontaneous adverse drug event databases is possible. From this analysis, various suspected drugs were detected. In particular, FAERS had many cases. The differences in the results between the two databases may reflect differences in the reporting countries. Further study of the relationship between drugs and CNS AEs should be conducted.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adverse Drug Reaction Reporting Systems - statistics & numerical data / Aged / Anticholinergics / Biology and Life Sciences / Care and treatment / Central nervous system / Central Nervous System Diseases - drug therapy / Central Nervous System Diseases - epidemiology / Central Nervous System Diseases - pathology / Cholinergic Antagonists - adverse effects / Constipation / Correlation / Correlation coefficient / Correlation coefficients / Criteria / Databases, Factual - statistics & numerical data / Delirium / Drug therapy / Drug-Related Side Effects and Adverse Reactions - epidemiology / Drug-Related Side Effects and Adverse Reactions - etiology / Drug-Related Side Effects and Adverse Reactions - pathology / Drugs / Geriatrics / Humans / Information management / Japan - epidemiology / Management / Medicine and Health Sciences / Narcotics / Nervous system / Older people / Opioids / Peripheral nervous system / Peripheral Nervous System Diseases - drug therapy / Peripheral Nervous System Diseases - epidemiology / Peripheral Nervous System Diseases - pathology / Pharmaceuticals / Pharmacy / Side effects / Software / United States - epidemiology