Hematological adverse events associated with anti-MRSA agents: a real-world analysis based on FAERS

ABSTRACT

This study investigated the patterns of hematological adverse events related to daptomycin (DAP), tigecycline (TIG), vancomycin (VAN) and linezolid (LIN) in the FDA Adverse Event Reporting System (FAERS). Adverse event associations were analyzed through calculating reporting odds ratio (ROR), proportional reporting ratio (PRR), multiple gamma Poisson shrinkage (MGPS), and Bayesian confidence propagation neural network (BCPNN). A comprehensive descriptive analysis was also conducted considering factors such as age, gender, daily dose, cumulative dose, and time to onset. The leading hematologic adverse events were eosinophilia for daptomycin, coagulation abnormalities and thrombocytopenia for tigecycline, thrombocytopenia, neutropenia, and anemia for linezolid, and thrombocytopenia, eosinophilia, and neutropenia for vancomycin. Most of the affected patients were over 55 years old. Daily doses for the tigecycline and daptomycin groups exceeded the standard daily dose. The times to onset were 14.00 days for daptomycin (interquartile range [IQR], 4.00–21.00), 6.00 days for tigecycline (IQR, 2.00–9.00), 10.00 days for linezolid (IQR, 4.00–16.5), and 10.00 days for vancomycin (IQR,5.00–20.00). It is essential to intensify early monitoring and identification of these adverse events, especially in the context of off-label dosages and for elderly patients and individuals taking medication for over one week.

KEYWORDS:

• Pharmacovigilance
• data mining
• anti-MRSA agents
• hematological adverse events
• FAERS

Declaration of interests

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.

Reviewer disclosures

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

Author contribution statement

Y.X.L.: concept and design, analysis and interpretation of data, manuscript preparation; Z.X.D: acquisition, analysis of data; L.M.: analysis and interpretation of data; Z.Y.: revision of the manuscript.

Ethics statement

This study, which was in compliance with the Declaration of Helsinki, received ethical approval from the Ethics Committee of University-Town hospital of Chongqing Medical University (Permit Number: LL-202327), and has applied for exemption from informed consent

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2309225

Additional information

Funding

This paper was funded by the Foundation of Medical research project of Chongqing Health Commission, China [2022WSJK049].