Linezolid and the risk of QT interval prolongation: A pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System

• Published in: British journal of clinical pharmacology Vol. 89; no. 4; pp. 1386 - 1392
• Main Authors: Shao, Haixia, Shi, Dawei, Dai, Ying
• Format: Journal Article
• Language: English
• Published: England 01.04.2023
• Subjects: cardiotoxicity; Humans; linezolid; Linezolid - adverse effects; long QT syndrome; Long QT Syndrome - chemically induced; Long QT Syndrome - epidemiology; Pharmacovigilance; QT interval prolongation; torsade de pointes; Torsades de Pointes; United States - epidemiology; United States Food and Drug Administration; United States; QT interval prolongation; torsade de pointes; cardiotoxicity; linezolid; long QT syndrome; pharmacovigilance
• ISSN: 0306-5251; 1365-2125
• DOI: 10.1111/bcp.15587

Aims Few studies have investigated linezolid (LZD)‐associated cardiotoxicity. This study explored the potential association between LZD and QT interval prolongation. Methods Adverse event reports of QT interval prolongation associated with LZD from the Food and Drug Administration Adverse Event Reporting System from January 2013 to December 2021 were analysed and the reporting odds ratio (ROR) with 95% confidence intervals were calculated. Results A total of 6738 adverse event reports of LZD as the primary and secondary suspected drug were obtained from the database, including 192 reports with electrocardiogram QT prolonged (QTp), and the ROR value was 26.1 (95% CI = 22.6–30.2). There were 8 reports of long QT syndrome, ROR 14.2 (95% CI = 7.1–28.5); 5 reports of torsade de pointes, ROR 3.2 (95% CI = 1.3–7.6); and 5 reports of ventricular tachycardia, ROR 1.9 (95% CI = 0.8–4.5). Subgroup analysis revealed that patients with tuberculosis treated with LZD had a higher reporting rate among all QTp reports, exhibiting an odds ratio of 330.0 (95% CI = 223.1–488.1). The odds ratios of QTp associated with LZD treatments in patients with and without tuberculosis were 4.2 (95% CI = 3.4–5.3) and 1.2 (95% CI = 0.8–1.6), respectively. Conclusion The study showed an association between LZD and QT interval prolongation. In the report on patients with tuberculosis, the incidence of QTp was higher when treated with LZD.