Drug-Associated Acute Kidney Injury Identified in the United States Food and Drug Administration Adverse Event Reporting System Database

2018 ◽  
Vol 38 (8) ◽  
pp. 785-793 ◽  
Author(s):  
Hanna K. Welch ◽  
John A. Kellum ◽  
Sandra L. Kane-Gill
Keyword(s):  
Acute Kidney Injury ◽  
Adverse Event ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Kidney Injury ◽  
The United States ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
United States Food ◽  
States Food

scholarly journals Assessment of pancreatitis associated with tocilizumab use using the United States Food and Drug Administration Adverse Event Reporting System database

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ashwin Kamath ◽  
Sahana D. Acharya ◽  
Rashmi R. Rao ◽  
Sheetal D. Ullal
Keyword(s):  
United States ◽  
Adverse Event ◽  
Lower Bound ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
The United States ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
United States Food ◽  
States Food

AbstractTocilizumab (TCZ) is used to treat rheumatoid arthritis and other systemic inflammatory disorders. There is some evidence suggesting the occurrence of pancreatitis following TCZ use. We aimed to determine the reporting of pancreatitis following TCZ use in comparison with other drugs using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. We extracted adverse event reports submitted to FAERS during 2013–2019. A reporting odds ratio (ROR) with the lower bound 95% confidence interval (CI) > 1 and a lower limit of a two-sided 95% interval of information component (IC025) more than zero was considered significant. Following deduplication, 3,383,910 adverse event reports were available; 144 (0.004%) reports were of pancreatic adverse events associated with TCZ use, and 15,907 (0.47%) associated with other drugs. Of the 144 cases, 74 (51.39%) received concomitant medications with pancreatotoxic potential. The likelihood of reporting of pancreatic events, compared with any other adverse event, with TCZ use was 1.32 times higher than that with other drugs. The lower bound of the 95% CI of the ROR and IC remained above the criteria of significance throughout the study period, except 2013. The findings suggest disproportionately high reporting of pancreatitis in patients receiving TCZ as compared with other drugs. This marginally high reporting is not likely to be of immediate clinical concern and needs to be interpreted cautiously.

scholarly journals Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system

PLoS ONE ◽  
2019 ◽  
Vol 14 (12) ◽  
pp. e0225572 ◽  
Author(s):  
Raymond K. Cross ◽  
Michael Chiorean ◽  
Francis Vekeman ◽  
Yongling Xiao ◽  
Eric Wu ◽  
...  
Keyword(s):  
United States ◽  
Adverse Event ◽  
Real World ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
The United States ◽  
Adverse Event Reporting ◽  
Event Reporting ◽  
United States Food ◽  
States Food
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