scholarly journals Bullous Pemphigoid and Diabetes medications: A disproportionality analysis based on the FDA Adverse Event Reporting System

2021 ◽  
Vol 18 (9) ◽  
pp. 1946-1952
Author(s):  
Liting Huang ◽  
Ying Liu ◽  
Huijun Li ◽  
Weicun Huang ◽  
Ruirui Geng ◽  
...  
Keyword(s):  
Adverse Event ◽  
Bullous Pemphigoid ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
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.

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