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Free Content Adverse drug reactions associated with first-line anti-tuberculosis drug regimens

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BACKGROUND: Standard treatment of active tuberculosis (TB) consists of isoniazid (INH), rifampin (RMP), pyrazinamide (PZA) and ethambutol (EMB). Although this regimen is effective in treating active TB, it is associated with many adverse drug reactions (ADRs) and poses a significant challenge to completion of treatment.

OBJECTIVES: To examine the incidence of major ADRs and risk factors associated with first-line anti-tuberculosis medications.

METHODS: This study evaluated patients receiving treatment for active TB from a population-based database (2000–2005). The nature of the ADRs, likelihood of association with the study medications and severity were evaluated.

RESULTS: A total of 1061 patients received treatment, of whom 318 (30%) had at least one major ADR. The overall incidence of all major ADRs was 7.3 events per 100 person-months (95%CI 7.2–7.5): 23.3 (95%CI 23.0–23.7) when on all four first-line drugs, 13.6 (95%CI 13.3–14.0) when on RMP, INH and PZA, and 2.4 (95%CI 2.3–2.6) when on INH and RMP. Adjusted hazard ratio (HR) revealed that combination regimens containing PZA, females, subjects aged 35–59 and ≥60 years, baseline aspartate aminotransferase ≥80 U/l and drug resistance were associated with any major event.

CONCLUSIONS: First-line anti-tuberculosis drugs are associated with significant ADRs. There are several risk factors associated with the development of ADRs, including exposure to regimens containing PZA.
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Keywords: adverse events; first-line medications; tuberculosis

Document Type: Regular Paper

Affiliations: 1: University of British Columbia, Vancouver, British Columbia, Canada; and BC Center for Disease Control, Vancouver, British Columbia, Canada 2: University of British Columbia, Vancouver, British Columbia, Canada; and Center for Health Evaluation and Outcome Sciences, Vancouver, British Columbia, Canada 3: University of British Columbia, Vancouver, British Columbia, Canada 4: BC Center for Disease Control, Vancouver, British Columbia, Canada 5: University of British Columbia, Vancouver, British Columbia, Canada; and Center for Clinical Epidemiology and Evaluation, Vancouver, British Columbia, Canada

Publication date: August 1, 2007

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on lung health world-wide.

    To share scientific research of immediate concern as rapidly as possible, The Union is fast-tracking the publication of certain articles from the IJTLD and publishing them on The Union website, prior to their publication in the Journal. Read fast-track articles.

    Certain IJTLD articles are also selected for translation into French, Spanish, Chinese or Russian. These are available on the Union website.

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