scholarly journals Enoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA Adverse Event Reporting System (FAERS)

2015 ◽  
Vol 2 (1) ◽  
Author(s):  
Katherine J. Hahn ◽  
Shannon J. Morales ◽  
James H. Lewis
Keyword(s):  
Adverse Event ◽  
Case Report ◽  
Liver Injury ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Review Of The Literature ◽  
Event Reporting

scholarly journals Drug-Induced Liver Injury Associated with Lopinavir- Ritonavir in Patients with COVID-19: A Disproportionality Analysis of U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) Data

2021 ◽  
Author(s):  
Huilin Tang ◽  
Liyuan Zhou ◽  
Xiaotong Li ◽  
Alan C Kinlaw ◽  
Jeff Y Yang ◽  
...  
Keyword(s):  
Adverse Event ◽  
Liver Injury ◽  
Drug Administration ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Event Reporting ◽  
Drug Induced Liver Injury

Abstract Background Liver injury has been documented independently in novel coronavirus disease 2019 (COVID-19) patients and patients treated with lopinavir-ritonavir. Objective to investigate the drug-induced liver injury associated with lopinavir-ritonavir among the patients with COVID-19. Methods We conducted a disproportionality analysis of US Food and Drug Administration Adverse Event Reporting System (FAERS) between 2020Q1 and 2020Q3 to evaluate the association between lopinavir-ritonavir and risk of drug-induced liver injury (or severe drug-induced liver injury) and calculated their reporting odds ratios (RORs) with 95% confidence intervals (CIs). Results A total of 1,754 reports of drug-induced liver injury in patients with COVID-19. The ROR for drug-induced liver injury was 1.4 (95% CI, 1.1–1.7), 3.6 (95% CI, 2.7–4.7), and 0.8 (95% CI, 0.7-1.0) when comparing lopinavir-ritonavir with all other drugs, hydroxychloroquine/chloroquine only, and remdesivir, respectively. For severe drug-induced liver injury, RORs for lopinavir-ritonavir provided evidence of an association compared with all other drugs (ROR, 4.9; 95% CI, 3.7–6.5), compared with hydroxychloroquine/chloroquine only (ROR, 4.3; 95% CI, 3.0-6.2), and compared with remdesivir (ROR, 10.4; 95% CI, 7.2–15.0). Conclusions In the FAERS, we observed a disproportional signal for severe drug-induced liver injury associated with lopinavir-ritonavir in patients with COVID-19.

Profiling Cumulative Proportional Reporting Ratios of Drug-Induced Liver Injury in the FDA Adverse Event Reporting System (FAERS) Database

Drug Safety ◽  
2013 ◽  
Vol 36 (12) ◽  
pp. 1169-1178 ◽  
Author(s):  
Allen D. Brinker ◽  
Jenna Lyndly ◽  
Joseph Tonning ◽  
David Moeny ◽  
Jonathan G. Levine ◽  
...  
Keyword(s):  
Adverse Event ◽  
Liver Injury ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Induced ◽  
Event Reporting ◽  
Drug Induced Liver Injury

Liver injury with drugs used for multiple sclerosis: A contemporary analysis of the FDA Adverse Event Reporting System

2018 ◽  
Vol 25 (12) ◽  
pp. 1633-1640 ◽  
Author(s):  
Ippazio Cosimo Antonazzo ◽  
Elisabetta Poluzzi ◽  
Emanuele Forcesi ◽  
Trond Riise ◽  
Kjetil Bjornevik ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Event ◽  
Liver Injury ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Dimethyl Fumarate ◽  
Population Based ◽  
Adverse Event Reporting ◽  
Drug Induced ◽  
Event Reporting

Background: Drug-induced liver injury (DILI) has been observed in patients with multiple sclerosis (MS), raising concerns on the liver safety of MS drugs. Objective: To describe DILI events with MS drugs by analyzing the FDA Adverse Event Reporting System. Methods: DILI reports were extracted and classified in overall liver injury (OLI), including asymptomatic elevation of liver enzymes, and severe liver injury (SLI). We performed disproportionality analysis by calculating adjusted reporting odds ratios (RORs) with 95% confidence interval (CI) and case-by-case evaluation for concomitant drugs with hepatotoxic potential. Results: Fampridine showed statistically significant ROR for both OLI and SLI, whereas teriflunomide and fingolimod generated solid disproportionality (ROR > 2) only for OLI (ROR, 2.31; 95% CI, 2.12–2.52; and 2.53; 2.40–2.66, respectively). Among monoclonal antibodies, only alemtuzumab generated higher-than-expected ROR for OLI (1.34; 1.09–1.65). We also detected the expected hepatotoxic potential of beta interferon and mitoxantrone. Concomitant reporting of hepatotoxic drugs ranged from 26% (dimethyl fumarate) to 90% (mitoxantrone). Conclusion: These real-world pharmacovigilance findings suggest that DILI might be a common feature of MS drugs and call for (1) formal population-based study to verify the risk of fampridine and (2) awareness by clinicians, who should assess the possible responsibility of MS drugs when they diagnose DILI.

Transient Bulging Fontanelle after Vaccination: Case Report and Review of the Vaccine Adverse Event Reporting System

2005 ◽  
Vol 147 (5) ◽  
pp. 640-644 ◽  
Author(s):  
Stephen B. Freedman ◽  
John Reed ◽  
Dale R. Burwen ◽  
Robert P. Wise ◽  
Amy Weiss ◽  
...  
Keyword(s):  
Adverse Event ◽  
Case Report ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting

Tocilizumab-induced pancreatitis: case report and review of data from the FDA Adverse Event Reporting System

2016 ◽  
Vol 41 (6) ◽  
pp. 718-721 ◽  
Author(s):  
T. Flaig ◽  
A. Douros ◽  
E. Bronder ◽  
A. Klimpel ◽  
R. Kreutz ◽  
...  
Keyword(s):  
Adverse Event ◽  
Case Report ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Event Reporting
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