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

TL;DR

This study examines serious side effects of tocilizumab in treating COVID-19 and other drugs in Bangladesh, highlighting the need for careful monitoring.

Contribution

The study provides real-world pharmacovigilance data on adverse events of tocilizumab and other drugs in a Bangladeshi tertiary care center.

Findings

Most tocilizumab-treated patients experienced serious adverse events, with one death reported.

All cyclosporine-treated patients had fatal outcomes, and high fatality rates were seen with insulin glargine and pazopanib.

The findings emphasize the importance of vigilant pharmacovigilance for these medications.

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 outcomes among reported SAEs; however, they should not be interpreted as statistically significant.

Conclusion

This study highlights serious adverse outcomes associated with tocilizumab and other commonly used medications in real-world clinical practice. Although casualty cannot be established due to the limited sample size and observational design, the findings emphasize the importance of vigilant pharmacovigilance and cautious interpretation of treatment outcomes.

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