Journal Article

Safety of Fluoroquinolone Use in Patients with Hepatotoxicity Induced by Anti-Tuberculosis Regimens

Chao-Chi Ho, Yee-Chun Chen, Fu-Chang Hu, Chong-Jen Yu, Pan-Chyr Yang and Kwen-Tay Luh

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 48, issue 11, pages 1526-1533
Published in print June 2009 | ISSN: 1058-4838
Published online June 2009 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/598929
Safety of Fluoroquinolone Use in Patients with Hepatotoxicity Induced by Anti-Tuberculosis Regimens

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Background. Fluoroquinolones are frequently used to replace agents in first-line anti-tuberculosis (anti-TB) regimens in patients with TB who have drug-induced hepatic dysfunction. We investigated the safety of using fluoroquinolone in an area where TB is endemic and where there is a high incidence of drug-induced liver injury.

Methods. From September 2003 through August 2006, patients who had aspartate aminotransferase and/or alanine aminotransferase levels >3 times the upper limit of normal in the presence of hepatitis symptoms or who had aspartate aminotransferase and/or alanine aminotransferase levels >5 times the upper limit of normal after receipt of anti-TB treatment were enrolled. The control group received ethambutol, with or without streptomycin; study groups received either (1) ethambutol plus levofloxacin, with or without streptomycin; or (2) ethambutol plus moxifloxacin, with or without streptomycin. The outcome measurement was the time from onset of hepatitis to normalization of liver functions.

Results. One hundred thirty-four (11.3%) of 1191 patients received a diagnosis of hepatotoxicity and needed to stop anti-TB treatment. The risk factor was abnormal baseline transaminase levels. Twenty-two of the 134 patients received the control medication, 40 received levofloxacin, and 45 received moxifloxacin; the remaining patients were excluded from the study. There were no significant prestudy differences between groups. Time to liver function normalization was almost the same for all groups (mean ± standard deviation, 29.1±21.4, 25.5±17.6, and 29.7±14.3 days, respectively).

Conclusions. Abnormal baseline transaminase levels are the independent risk factors for anti-TB therapy-induced hepatitis. Levofloxacin and moxifloxacin caused no additional hepatotoxicity when they were used by patients with hepatitis induced by first-line anti-TB drugs.

Journal Article.  3937 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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