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Published ahead of print on January 31, 2003, doi:10.1164/rccm.200206-626OC

Am. J. Respir. Crit. Care Med., Volume 167, Number 11, June 2003, 1472-1477

A more recent version of this article appeared on June 1, 2003
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Submitted on June 27, 2002
Accepted on January 30, 2003

Incidence of serious side effects from first-line anti-TB drugs among patients treated for active TB

Daphne Yee1, Chantal Valiquette2, Marthe Pelletier2, Isabelle Parisien2, Isabelle Rocher2, and Dick Menzies3*

1 Respiratory Epidemiology Unit, McGill University, Montreal, QC, Canada, 2 Montreal Chest Institute, Montreal, QC, Canada, 3 Respiratory Epidemiology Unit, McGill University, Montreal, QC, Canada; Respiratory Epidemiology Unit, McGill University, Montreal, QC, Canada

* To whom correspondence should be addressed. E-mail: dick.menzies{at}mcgill.ca.

Major adverse reactions to anti-tuberculosis drugs can cause significant morbidity, and compromise treatment regimens for tuberculosis (TB). Among patients treated for active TB we estimated the incidence, and risk factors, of major side effects from first-line anti-TB drugs. Side effects, resulting in modification or discontinuation of therapy, or hospitalization, were attributed based on resolution following withdrawal, and/or recurrence with re-challenge. Among 430 patients treated between 1990-1999, incidence of all major adverse effects was 1.48 per 100 person months of exposure (95% Confidence Interval: 1.31,1.61), for Pyrazinamide (PZA), compared to 0.49 (0.42,0.55) for Isoniazid (INH), 0.43 (0.37,0.49) for Rifampin (RIF), and 0.07 (0.04,0.10) for Ethambutol (EMB). Occurrence of any major side effect was associated with female gender [adjusted hazard ratio: 2.5; (95% CI: 1.3, 4.7)], age over 60 [2.9 (1.3, 6.3)], birthplace in Asia [2.5 (1.3, 5.0)], and HIV positive status [3.8 (1.05, 13.4)]. PZA-associated adverse events were associated with age over 60 [2.6(1.01, 6.6] and Asian birthplace [3.4;(1.4,8.3)], while RIF-associated adverse events were associated with age over 60 [3.9(1.02, 14.9], and HIV positive status [8.0 (1.5, 43)]. The incidence of PZA-induced hepatotoxicity and rash during treatment for active TB was substantially higher than with the other first line anti-TB drugs, and higher than previously recognized.
Key words: TB Treatment; Side Effects; Adverse Drug Reactions




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