Post-marketing Drug Safety Evaluation Using Data Mining Based on FAERS

Duan, Rui; Zhang, Mengjie; Du, Jingcheng; Huang, Jing; Tao, Cui; Chen, Yong

doi:10.1007/978-3-319-61845-6_38

Cited by 6 publications

(2 citation statements)

References 13 publications

(16 reference statements)

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“…9 We have previously investigated this database to explore the feasibility of using FAERS to analyze mental health drug safety using 12 first-line antidepressants drugs. 10 We found that our results were qualitatively in agreement with results from the recent comprehensive systematic review of randomized controlled trials. 5 Moreover, our postmarketing analysis based on FAERS provided more insight into different types of adverse reactions with respect to different classes of human organ system and a larger population.…”

Section: Introductionsupporting

confidence: 90%

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Duan

Zhang

et al. 2019

Health Informatics J

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Evaluation of premarketing drug safety in clinical trials is often limited, due to the relatively small sample size and short follow-up time. The data collected in the postmarketing spontaneous reporting systems such as Food and Drug Administration Adverse Event Reporting System as well as electronic medical record systems provide crucial information to evaluate postmarketing drug safety. In this article, we assess the strengths and limitations of Food and Drug Administration Adverse Event Reporting System and electronic medical record data in studying the postmarketing pharmacovigilance outcomes for 12 selected antidepressant drugs. In addition, we evaluate the consistency of the results obtained from these two data sources, and provide potential directions for evidence integration.

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Section: Introductionsupporting

confidence: 90%

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Duan

Zhang

et al. 2019

Health Informatics J

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“…The U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS) provides information on medication error reports and adverse events (AEs). Data mining algorithms are routinely applied for the quantitative detection of signals, such as drug-associated AEs ( 8 ). Therefore, we aim to assess the potential relevance between ACEIs and primary malignant lung cancer AE reports through data mining of the FAERS.…”

Section: Introductionmentioning

confidence: 99%

Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database

et al. 2021

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Because of contradictory evidence from clinical trials, the association between angiotensin-converting enzyme inhibitors (ACEIs) and lung cancer needs further evaluation. As such, the current study is to assess disproportionate reporting of primary malignant lung cancer among reports for ACEIs submitted to the FDA adverse event reporting system utilizing a pharmacovigilance approach. We conducted a disproportionality analysis of primary malignant lung cancer adverse events associated with 10 ACEIs by calculating the reported odds ratios (ROR) and information component (IC) with 95% confidence intervals (CI). ROR was adjusted for sex, age, and reporting year by logistic regression analyses. From January 2004 to March 2020, a total of 622 cases of lung cancer adverse event reports were identified for ACEIs users. Significant disproportionate association was found for ACEIs as a drug class (ROR: 1.22, 95% CI: 1.13–1.32; IC: 0.28, 95% CI: 0.17–0.39. adjusted ROR: 1.23, 95% CI: 1.02–1.49). After stratification based on gender, a subset analysis suggested that female patients exhibited a significant disproportionate association, while male patients did not. Sensitivity analyses that limited the data by reporting region, comorbidity, and reporting year also showed similar trends. Statistical significant lung cancer signals were detected among patients who received ACEI, especially female patients. The disproportionality analysis of the FAERS database suggests mildly increased reporting of lung cancer among ACEI users. Further robust epidemiological studies are necessary to confirm this relationship.

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Anaplastic lymphoma kinase tyrosine kinase inhibitors associated gastrointestinal obstruction, perforation, and ulceration: an analysis of the FDA adverse event reporting system database (FAERS)

et al. 2022

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Post-marketing Drug Safety Evaluation Using Data Mining Based on FAERS

Cited by 6 publications

References 13 publications

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Lung Cancer Adverse Events Reports for Angiotensin-Converting Enzyme Inhibitors: Data Mining of the FDA Adverse Event Reporting System Database

Anaplastic lymphoma kinase tyrosine kinase inhibitors associated gastrointestinal obstruction, perforation, and ulceration: an analysis of the FDA adverse event reporting system database (FAERS)

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