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The Safety of Levofloxacin in Tuberculosis Treatment Including Drug-induced Hepatotoxicity

Chao-Chi Ho, MD, PhD
Chong-Jen Yu, MD, PhD
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan


Tuberculosis continues to be a significant health problem throughout the world. Combination therapy is necessary for short-course antituberculosis treatment, but this increases the risk of adverse drug events significantly including hepatotoxicity. Fluoroquinolones are frequently used to replace first-line antituberculosis agents in multidrug-resistant tuberculosis patients or as a substitute drug for those patients who are unable to tolerate first-line drugs. Levofloxacin as, like other new fluoroquinolones, exhibits high bactericidal activity against Mycobacterium tuberculosis. Although the safety profile of levofloxacin when used in short-course treatment for bacterial infections has been well-established, its safety in tuberculosis treatment, especially after first-line antituberculosis drug-induced hepatotoxicity, is unclear. A comprehensive review of the medical literature has identified six publications including three small randomized controlled trials and two written in Chinese evaluating the use of levofloxacin in tuberculosis treatment and the reported adverse events. The findings of these studies showed non-inferiority and the adverse events did not increase even after adding levofloxacin to other antituberculosis drugs. The use of levofloxacin after hepatitis induced by antituberculosis drugs produced no additional hepatotoxicity. The published data support the safety of levofloxacin use in tuberculosis treatment and even after first-line antituberculosis drug-induced hepatitis. Further trials with large patient numbers are necessary to evaluate the efficacy and safety of levofloxacin in the management of tuberculosis.

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