Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada

This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canad...

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Bibliographic Details
Published in:PloS one 2015-12, Vol.10 (12), p.e0144337
Main Authors: Ali, Thibault B, Schleret, Thomas R, Reilly, Brian M, Chen, Winston Yuchen, Abagyan, Ruben
Format: Article
Language:English
Subjects:
Acetylcholinesterase
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Alzheimer Disease - drug therapy
Alzheimer's disease
Analysis
Canada
Care and treatment
Cholinesterase
Cholinesterase inhibitors
Cholinesterase Inhibitors - adverse effects
Clinical trials
Data bases
Databases, Factual
Dementia
Dementia - drug therapy
Dementia disorders
Development and progression
Donepezil
Drug therapy
FDA approval
Galantamine - adverse effects
Health aspects
Humans
Indans - adverse effects
Inhibitors
Internet
Marketing
Medical errors
Online data bases
Patient outcomes
Pharmaceutical sciences
Pharmacology
Pharmacovigilance
Pharmacy
Piperidines - adverse effects
Product safety
Rivastigmine
Rivastigmine - adverse effects
Side effects
Statistical analysis
United States
United States Food and Drug Administration
Vigilance
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Summary:This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD) concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR). A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI95% = 2.94-3.98; P
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0144337