PMID- 34855908
OWN - NLM
STAT- MEDLINE
DCOM- 20220114
LR  - 20220114
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 16
IP  - 12
DP  - 2021
TI  - 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.
PG  - e0260980
LID - 10.1371/journal.pone.0260980 [doi]
LID - e0260980
AB  - INTRODUCTION: 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? METHODS: 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(R). RESULTS: 
      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(R), 
      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. 
      CONCLUSIONS: 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.
FAU - Nagai, Junko
AU  - Nagai J
AUID- ORCID: 0000-0002-9069-5752
AD  - The Office of Institutional Research, Meiji Pharmaceutical University, Kiyose, 
      Tokyo, Japan.
FAU - Ishikawa, Yoichi
AU  - Ishikawa Y
AD  - Division of Clinical Pharmacy, Department of Pediatric Pharmaceutical Sciences, 
      Education and Research Center for Pharmacy, Meiji Pharmaceutical University, 
      Kiyose, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20211202
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Cholinergic Antagonists)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Central Nervous System Diseases/*drug therapy/epidemiology/pathology
MH  - Cholinergic Antagonists/*adverse effects
MH  - Databases, Factual/*statistics & numerical data
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology/pathology
MH  - Humans
MH  - Japan/epidemiology
MH  - Peripheral Nervous System Diseases/*drug therapy/epidemiology/pathology
MH  - Software
MH  - United States/epidemiology
PMC - PMC8638968
COIS- The authors have declared that no competing interests exist.
EDAT- 2021/12/03 06:00
MHDA- 2022/01/15 06:00
PMCR- 2021/12/02
CRDT- 2021/12/02 17:34
PHST- 2021/07/30 00:00 [received]
PHST- 2021/11/21 00:00 [accepted]
PHST- 2021/12/02 17:34 [entrez]
PHST- 2021/12/03 06:00 [pubmed]
PHST- 2022/01/15 06:00 [medline]
PHST- 2021/12/02 00:00 [pmc-release]
AID - PONE-D-21-24784 [pii]
AID - 10.1371/journal.pone.0260980 [doi]
PST - epublish
SO  - PLoS One. 2021 Dec 2;16(12):e0260980. doi: 10.1371/journal.pone.0260980. 
      eCollection 2021.