Comparisons of adverse event reporting for colistin versus polymyxin B using the US Food and Drug Administration Adverse Event Reporting System (FAERS)

ABSTRACT

Background: The polymyxins (colistin and polymyxin B) have recently reemerged in clinical practice. With the same antimicrobial activities, colistin has been more frequently prescribed in most countries, although available evidence on their nephrotoxicity is conflicting.

Methods: The US Food and Drug Administration Adverse Event Reporting System (FAERS) data from Q1-2004 to Q1-2020 were used to identify adverse events (AE) reports. We described the reporting patterns and compare the reporting rates of serious AEs, acute kidney diseases (AKD), and death between colistin and polymyxin B using reporting odds ratios (RORs).

Results: The annual number of AE reports increased over time for both drugs. Heterogeneity in reporting characteristics was observed in age and reporter region. RORs of serious, AKD, and death AEs were significantly higher for both drugs versus other drugs. RORs of serious and AKD AEs were higher for colistin compared to polymyxin B (p = 0.0479 and p = 0.0306, respectively), but no difference in death RORs was detected (p = 0.2211).

Conclusions: This study showed higher reporting rates of serious AEs and AKD for colistin than polymyxin B, but no difference in death. The findings support future research with stronger study design and larger sample size for the safety comparison between colistin and polymyxin B.

KEYWORDS:

• Polymyxins
• colistin
• polymyxin B
• kidney diseases
• mortality
• antibiotics

Author contributions

Truong, and Qian had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: All authors. Acquisition, analysis, or interpretation of data: all authors. Drafting of the paper: All authors. Critical revision of the paper for important intellectual content: All authors. Statistical analysis: Truong. Study supervision: Qian.

Availability of data and materials

Raw data for this article can be downloaded at FDA Adverse Event Reporting System (FAERS) Quarterly Data Extract Files: https://fis.fda.gov/extensions/FPD-QDEFAERS/FPD-QDE-FAERS.html

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Ethics approval

The study was granted exemption by the Auburn University institutional review board (IRB) and the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.