Adverse and Serious Adverse Events Associated With Tocilizumab in COVID-19 Pneumonia and With Cyclosporin, Pazopanib, and Insulin Glargine in Other Diseases: A Single-Center Cross-Sectional Study From a Tertiary Care Center in Bangladesh
Abstract
Objective This study aimed to evaluate reported adverse events (AEs) and serious adverse events (SAEs) associated with tocilizumab in COVID-19 pneumonia and with cyclosporine, insulin glargine, and pazopanib in other clinical indications using real-world pharmacovigilance data. Methods This cross-sectional observational study analyzed suspected SAE reports submitted to the National Pharmacovigilance Centre (NPC), Directorate General of Drug Administration (DGDA), Bangladesh, between March and July 2020 from a tertiary care center in Bangladesh. A total of 60 patients were included. Of these, 46 received tocilizumab for COVID-19 pneumonia, and 14 received cyclosporine (n=5), insulin glargine (n=4), or pazopanib (n=5) for other indications. Incomplete reports were excluded to minimize bias. Descriptive statistics and association analyses were performed to evaluate patient characteristics, outcomes, and dose-outcome relationships. Results After the exclusion of incomplete records, 28 patients treated with tocilizumab were analyzed. The majority were male (25/28, 89.29%), with a mean age of 59.75±15.23 years. SAEs occurred in 27 patients (96.43%), predominantly categorized as "other medically important conditions", and one death (1/28, 3.57%) was reported. All five patients receiving cyclosporine experienced fatal outcomes (5/5, 100%). Fatal outcomes were observed in 3/4 patients (75%) receiving insulin glargine and in 2/5 patients (40%) receiving pazopanib. The results reflect…
How strong is the evidence?
Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 60 participants or records.
Read the paper
Related studies
- Severe clinical outcomes of COVID-19 associated with proton pump inhibitors: a nationwide cohort study with propensity score matching
- Levofloxacin-Induced Tendon Rupture: A Case Report and Review of the Literature
- Association between cord blood 25-hydroxyvitamin D concentrations and respiratory tract infections in the first 6 months of age in a Korean population: a birth cohort study (COCOA)
- Neuroprotective Effects of Epicatechin against Oxidative Stress-Induced Cognitive Impairment: A Systematic Review and Meta-Analysis
- Quality evaluation and in vitro interaction studies between levofloxacin 250mg and diclofenac sodium 50mg tablets
- Molecular Epidemiology of mcr-1 -Positive Polymyxin B-Resistant Escherichia coli Producing Extended-Spectrum β-Lactamase (ESBL) in a Tertiary Hospital in Shandong, China
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.