A retrospective TBNET assessment of linezolid safety, tolerability and efficacy in multidrug-resistant tuberculosis

G. B. Migliori, B. Eker, M. D. Richardson, G. Sotgiu, J. P. Zellweger, A. Skrahina, J. Ortmann, E. Girardi, H. Hoffmann, G. Besozzi, N. Bevilacqua, D. Kirsten, R. Centis, C. Lange

Research output: Contribution to journalArticlepeer-review


Linezolid is used to treat patients with multidrug-resistant (MDR)/extensively drug-resistant (XDR)-tuberculosis (TB) cases, although clinical data on its safety, tolerability and efficacy are lacking. We performed a retrospective, nonrandomised, unblinded observational study evaluating the safety and tolerability of linezolid at 600 mg q.d. or b.i.d. in MDR/XDR-TB treatment in four European countries. Efficacy evaluation compared end-points of 45 linezolid-treated against 110 linezolid-nontreated cases. Out of 195 MDR/XDR-TB patients, 85 were treated with linezolid for a mean of 221 days. Of these, 35 (41.2%) out of 85 experienced major side-effects attributed to linezolid (anaemia, thrombocytopenia and/or polyneuropathy), requiring discontinuation in 27 (77%) cases. Most side-effects occurred after 60 days of treatment. Twice-daily administration produced more major side-effects than once-daily dosing (p=0.0004), with no difference in efficacy found. Outcomes were similar in patients treated with/without linezolid (p=0.8), although linezolid-treated cases had more first-line (p=0.002) and second-line (p=0.02) drug resistance and a higher number of previous treatment regimens (4.5 versus 2.3; p=0.07). Linezolid 600 mg q.d. added to an individualised multidrug regimen may improve the chance of bacteriological conversion, providing a better chance of treatment success in only the most complicated MDR/XDR-TB cases. Its safety profile does not warrant use in cases for which there are other, safer, alternatives. Copyright

Original languageEnglish
Pages (from-to)387-393
Number of pages7
JournalEuropean Respiratory Journal
Issue number2
Publication statusPublished - Aug 2008


  • Efficacy
  • Extensively drug-resistant tuberculosis
  • Linezolid
  • Multidrug-resistant tuberculosis
  • Safety
  • Tolerability

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine


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