Colistin-associated Stevens-Johnson syndrome and toxic epidermal necrolysis reactions: a retrospective case-non-case pharmacovigilance study. Issue 8 (3rd August 2022)

• Record Type: Journal Article
• Authors: Tang, Richard; Lopes, Vrishali L.; Caffrey, Aisling R.
• Is Part Of: Expert opinion on drug safety. Volume 21:Issue 8(2022)
• Page Start: 1121
• Page End: 1126
• Publication Date: 2022-08-03
• Subjects: Colistin -- FDA adverse event reporting system -- Stevens-Johnson syndrome -- toxic epidermal necrolysis; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2022.2045945
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening skin reactions. Colistin is a last resort antibiotic with a historically poor safety profile. The association between colistin and SJS/TEN has not been previously quantified. Research design and methods: We identified colistin and SJS/TEN adverse event reports from the Food and Drug Administration Adverse Event Reporting System (FAERS) and calculated effect estimates using OpenEpi. Results: From January 2013 through March 2021, 964 adverse events were reported for colistin. Colistin was listed as a secondary suspect drug in 13 SJS/TEN adverse event reports (1.3%), with a reporting odds ratio of 29.6 (95% confidence interval [CI] 17.1–51.1), and proportional reporting ratio of 29.2 (95% CI 17.0–50.2). Limitations of any FAERS study include the voluntary nature of reporting, unclear causal relationship between drug and adverse reaction, underreporting, and wide confidence intervals for rare adverse events like SJS/TEN. Conclusions: Colistin was not the primary suspect drug in any SJS/TEN adverse event reports. We did identify a statistically significant safety signal for SJS/TEN with colistin as a secondary suspect drug. SJS/TEN is not currently included in the colistin product label. This association should be further explored in other pharmacoepidemiologic drug safety studies.