Severe and lethal adverse reactions of linezolid—a summary analysis of case reports

doi:10.5246/jcps.2022.02.013

Abstract

Abstract:

A systematic summary was used to evaluate case reports of adverse drug reactions (ADRs) caused by linezolid, and to explore the effects and severity on human organs or systems in the real world. The databases, such as PubMed, Embase, Cochrane Library, and CINAHL, were searched using "linezolid" + "case reports" as search terms from the establishment of each database to 31st December 2019, and the case reports on ADRs related to linezolid were collected. A total of 159 case reports were finally included in the analysis, including 189 patients. The ratio of male to female was 0.89:1, and the average age was (52.42 ± 23.43) years old. The results showed that linezolid-related severe ADRs mainly occurred in the nervous system (n = 86) and blood system (n = 44), followed by the metabolic system (n = 31) and gastrointestinal system (n = 18). Other systems reported less frequently were the skin tissue (n = 6), renal and urinary system (n = 3), cardiovascular systems (n = 2), and hepatobiliary system (n = 2). The most common linezolid-related ADRs were serotonin syndrome (n = 40), followed by optic neuropathy (n = 25) and thrombocytopenia (n = 22). The most severe ADR was lactic acidosis (n = 29), and its death rate was as high as 31.0%. In the blood system ADRs, 11 cases had underlying diseases of renal impairment, and four of them died. Moreover, 22 cases with thrombocytopenia were mainly elderly over 65 years old (n = 17), and there were also one infant and one child with thrombocytopenia. We first reported that lactic acidosis and blood system ADRs mostly occurred within 28 d, and the nervous system ADRs mostly occurred after 28 d. Besides, irreversible auditory neuropathy (n = 1), hypophosphatemia (n = 1), bradycardia (n = 1), and tooth discoloration mostly occurring in minors (n = 5) were the linezolid-related ADRs, which were not described in the instructions, related guidelines, and clinical trials of linezolid. The most severe linezolid-related ADRs was lactic acidosis that occurred within 28 d. Renal damage and special populations might be the main risk factors in the blood system ADRs. Minor linezolid-related ADRs were rare, while there were still some cases of auditory neuropathy, hypophosphatemia, bradycardia, and tooth discoloration.

Key words: Linezolid, Adverse drug reactions, Lactic acidosis, Case reports

Supporting:

Yanyu Pei, Jihui Hao, Wenqi Duan, Yujing Zheng, Ming Zhao, Liping Yang. Severe and lethal adverse reactions of linezolid—a summary analysis of case reports[J]. Journal of Chinese Pharmaceutical Sciences, 2022, 31(2): 153-161.

Figures/Tables 6

Table 1. Distribution of age and gender in patients.

Table 2. Distribution of linezolid-related ADRs in different durations of linezolid therapy.

Table 3. Summary of 189 case reports of linezolid-related ADRs in different systems/organs.

Table 4. Summary of 189 case reports of linezolid-related ADRs in different systems/organs.

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