scholarly journals Hepatotoxicity-Related Adverse Effects of Proton Pump Inhibitors: A Cross-Sectional Study of Signal Mining and Analysis of the FDA Adverse Event Report System Database

2021 ◽  
Vol 8 ◽  
Author(s):  
Yifan Zeng ◽  
Ying Dai ◽  
Ziye Zhou ◽  
Xuben Yu ◽  
Dawei Shi
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Case Reports ◽  
Adverse Event Reporting System ◽  
Adverse Event Report ◽  
Event Report ◽  
Hepatocellular Injury ◽  
Suspect Drug

Background and Objectives: Mounting evidence demonstrates that proton pump inhibitors (PPIs) are associated with a number of adverse effects. However, the literatures about hepatotoxicity-related adverse effects (HRAEs) of PPIs are mostly case reports and a few clinical studies.Methods: We evaluated the association between PPIs and HAREs using the reporting odd ratio (ROR) for mining the adverse event report signals in the FDA Adverse Event Reporting System (FAERS) database.Results: There were 23,825 reports of PPIs as primary suspect drug or second suspect drug, of which 3,253 reports were HRAEs. The top five HRAE signals caused by PPIs were hepatitis cholestatic, cholestasis, fulminant hepatitis, subacute hepatic failure, and acute hepatitis. We also summarized the signals of the HRAEs caused by each PPI. The simultaneous signals were cholestasis and hepatitis cholestatic. For the cholestasis signal, esomeprazole showed an ROR of 21.556 (95% CI 17.592–26.413); pantoprazole showed the highest ROR of 22.611 (95% CI 17.794–28.733) in the hepatic cholestatic signal; lansoprazole was the only PPI with expression in the coma hepatic signal, with an ROR of 10.424 (95% CI 3.340–32.532). By analyzing the reports of pantoprazole-induced hepatic encephalopathy, we found that patients aged over 65 years and males reported the highest rate. And from the combination of drugs and indications of drugs, no significant results were obtained.Conclusions: The RORs of signals of “cholestasis” were generally higher than those of “hepatocellular injury.” And the signals about “cholestasis” in HRAE caused by PPIs are more reported.

Application of FDA Adverse Event Report Data to the Surveillance of Dietary Botanical Supplements

2008 ◽  
Vol 42 (5) ◽  
pp. 653-660 ◽  
Author(s):  
Robert B Wallace ◽  
Brian M Gryzlak ◽  
M Bridget Zimmerman ◽  
Nicole L Nisly
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Product Information ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Adverse Event Report ◽  
St John’S Wort ◽  
St John's Wort ◽  
Botanical Supplements

Background: Concerns have been raised about the sufficiency of dietary botanical supplement (DBS) surveillance in the US. The Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms, but it has not been well characterized with respect to DBS adverse effects. Objective: To characterize data on DBSs associated with adverse event reports submitted to CAERS. Methods: We requested and obtained CAERS data from 1999 to 2003 involving adverse effects associated with the 6 most frequently used DBSs: Echinacea, ginseng, garlic, Ginkgo biloba, St. John's wort, and peppermint. We summarized and characterized the adverse event reports received, focusing on the composition of the DBSs and the nature of associated adverse events. We also cross-referenced reported single-ingredient DBSs with corresponding available product information. A sample of CAERS cases associated with signal DBSs was also characterized in detail. Results: CAERS reports involving ginseng DBSs were most frequently reported during the study period, whereas reports involving St. John's wort were the least frequently reported. Most CAERS reports involved multiple-ingredient DBSs, and 3-13% of reports involved multiple DBSs. Gastrointestinal and neurologic problems were the most common clinical outcomes among single-ingredient DBS-associated adverse events. Conclusions: CAERS surveillance of DBS adverse effects is potentially as effective as other passive surveillance methods, but the number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found. Reports in CAERS may underrepresent DBS adverse events associated with DBS consumption.

Can Natural Language Processing Improve the Efficiency of Vaccine Adverse Event Report Review?

2016 ◽  
Vol 55 (02) ◽  
pp. 144-150 ◽  
Author(s):  
M. Nguyen ◽  
E. J. Woo ◽  
S. Winiecki ◽  
J. Scott ◽  
D. Martin ◽  
...  
Keyword(s):  
Adverse Event ◽  
Information Extraction ◽  
Full Text ◽  
Alternative Explanation ◽  
Adverse Event Reporting System ◽  
Time Interval ◽  
Adverse Event Report ◽  
Event Report ◽  
Review Time ◽  
Time To Onset

SummaryBackground: Individual case review of spontaneous adverse event (AE) reports remains a cornerstone of medical product safety surveil-lance for industry and regulators. Previously we developed the Vaccine Adverse Event Text Miner (VaeTM) to offer automated information extraction and potentially accelerate the evaluation of large volumes of unstructured data and facilitate signal detection.Objective: To assess how the information extraction performed by VaeTM impacts the accuracy of a medical expert’s review of the vaccine adverse event report.Methods: The “outcome of interest” (diagnosis, cause of death, second level diagnosis), “onset time,” and “alternative explanations” (drug, medical and family history) for the adverse event were extracted from 1000 reports from the Vaccine Adverse Event Reporting System (VAERS) using the VaeTM system. We compared the human interpretation, by medical experts, of the VaeTM extracted data with their interpretation of the traditional full text reports for these three variables. Two experienced clinicians alternately reviewed text miner output and full text. A third clinician scored the match rate using a predefined algorithm; the proportion of matches and 95% confidence intervals (CI) were calculated. Review time per report was analyzed.Results: Proportion of matches between the interpretation of the VaeTM extracted data, compared to the interpretation of the full text: 93% for outcome of interest (95% CI: 91– 94%) and 78% for alternative explanation (95% CI: 75 – 81%). Extracted data on the time to onset was used in 14% of cases and was a match in 54% (95% CI: 46 – 63%) of those cases. When supported by structured time data from reports, the match for time to onset was 79% (95% CI: 76 – 81%). The extracted text averaged 136 (74%) fewer words, resulting in a mean reduction in review time of 50 (58%) seconds per report.Conclusion: Despite a 74% reduction in words, the clinical conclusion from VaeTM extracted data agreed with the full text in 93% and 78% of reports for the outcome of interest and alternative explanation, respec -tively. The limited amount of extracted time interval data indicates the need for further development of this feature. VaeTM may improve review efficiency, but further study is needed to determine if this level of agreement is sufficient for routine use.

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