scholarly journals 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

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0260980
Author(s):  
Junko Nagai ◽  
Yoichi Ishikawa
Keyword(s):  
Adverse Event ◽  
Adverse Drug Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Beers Criteria ◽  
Event Report ◽  
Event Reporting ◽  
The Us

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®. 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®, 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.

scholarly journals Assessment of Reye’s syndrome profile with data from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases using the disproportionality analysis

2020 ◽  
Vol 8 ◽  
pp. 205031212097417
Author(s):  
Kiyoka Matsumoto ◽  
Shiori Hasegawa ◽  
Satoshi Nakao ◽  
Kazuyo Shimada ◽  
Ririka Mukai ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Drug Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Event ◽  
Event Report ◽  
Reye's Syndrome ◽  
Event Reporting ◽  
The Us

Objectives: Reye’s syndrome is a rare and potentially fatal illness that is defined as encephalopathy accompanied by liver failure. The aim of this study was to assess Reye’s syndrome profiles by analyzing data from the spontaneous reporting system database. Methods: We analyzed reports of Reye’s syndrome using the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases. The reporting odds ratio and proportional reporting rate were used to detect the pharmacovigilance signal. Results: The US Food and Drug Administration Adverse Event Reporting System contains 12,201,620 reports from January 2004 to June 2020, of which 186 are on Reye’s syndrome. The Japanese Adverse Drug Event Report contains 646,779 reports from April 2004 to September 2020, of which 30 are on Reye’s syndrome. In the US Food and Drug Administration Adverse Event Reporting System database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, acetaminophen, and valproate sodium were 404.6 (302.6–541.0, n = 80), 15.1 (6.7–34.1, n = 6), 26.2 (16.1–42.6, n = 18), 10.7 (5.5–20.9, n = 9), and 47.1 (26.2–84.6, n = 12), respectively. In the Japanese Adverse Drug Event Report database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, loxoprofen, acetaminophen, and valproate sodium were 14.1 (5.4–36.8, n = 5), 51.7 (22.2–120.5, n = 7), 135.0 (40.8–446.2, n = 3), 17.6 (6.7–46.0, n = 5), 24.0 (9.2–62.6, n = 5), and 13.8 (3.3–57.9, n = 2), respectively. The reported number of female patients aged 30–39 years was the highest in the Japanese Adverse Drug Event Report. Conclusion: Although the frequency of the occurrence of Reye’s syndrome is low, the possible risk of the disease occurring in adult females should be considered.

scholarly journals Cardiovascular Safety Profile of Romosozumab: A Pharmacovigilance Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS)

2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  
Keyword(s):  
Adverse Event ◽  
Drug Administration ◽  
Cardiovascular Events ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Cardiovascular Safety ◽  
Event Reporting ◽  
The Us

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients.

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