Document Type

Article

Date of Original Version

2017

Abstract

Objective: Though thrombocytopenia is a known adverse effect with linezolid, the first-in class oxazolidinone antibiotic, some have suggested a lower risk of thrombocytopenia with tedizolid, the second-in-class oxazolidinone antibiotic. We sought to evaluate adverse event reports for thrombocytopenia with tedizolid and linezolid from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: To assess the period since tedizolid approval, we included initial FAERS reports from July 2014 through December 2016. To evaluate historical rates with linezolid prior to tedizolid approval, we assessed AERSMine data from January 2004 through June 2014. Reporting odds ratios (ROR) and proportional reporting ratios (PRR) were calculated.

Results: Of all the reported events, 0.074% (n=1,468) were thrombocytopenia. Linezolid represented 0.02% (n=408) of all events, and tedizolid represented 0.002% (n=41). The ROR for thrombocytopenia with linezolid was 37.9 (95% confidence interval [CI] 20.78-69.17) and with tedizolid was 34.0 (95% CI 4.67- 247.30). The PRR for thrombocytopenia with linezolid was 36.9 (95% CI 20.56-66.28) and with tedizolid was 33.2 (95% CI 4.79- 230.10). From 2004 through June 2014, the linezolid ROR was 12.1 (95% CI 11.19-12.96) and PRR was 11.1 (95% CI 10.38-11.87).

Conclusion: We observed a significantly increased risk of thrombocytopenia of similar magnitude with both linezolid and tedizolid. Thrombocytopenia with tedizolid should be assessed with real-world comparative safety studies as more patients are treated with tedizolid.

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