Drug safety in hospitalized patients with tuberculosis: Drug interactions and adverse drug effects.

BACKGROUND

Hospitalized patients with tuberculosis (TB) are prescribed with drugs having high risk of potential drug-drug interactions (pDDIs) and adverse drug effects (ADEs).

OBJECTIVES

To explore the adverse effects of anti-tuberculosis (anti-TB) drugs and the prevalence and predictors of pDDIs in hospitalized patients with TB.

METHODS

Clinical profiles of 436 TB patients were reviewed for adverse effects induced by anti-TB drugs and screened for pDDIs using Micromedex-DrugReax. Prevalence and severity levels of pDDIs were reported. Odds ratios for predictors were calculated using logistic regression analysis.

RESULTS

Of total 436 patients, adverse effects of anti-TB drugs were found in 36%. ADEs were highly prevalent in patients with high doses of anti-TB drugs. Hepatotoxicity, neuropathy, insomnia, arthralgia, psychosis, hematological alterations, skin rashes, red color stool, diplopia, and photophobia were the identified ADEs. All drugs types- and anti-TB drugs-pDDIs were reported in 78.2% and 55.7%, respectively. Major-pDDIs of anti-TB drugs were identified in 55.5%. Total 1090 anti-TB drugs pDDIs were found, among them, 55.6% were of major- and 40.5% were of moderate-severity. Significant association was observed for the pDDIs with ≥7 prescribed medicines (P < 0.001). Potential adverse outcomes of the most frequent interactions were hepatotoxicity, decreased drug's effectiveness, QT-interval prolongation, nephrotoxicity, and gastrointestinal ulceration.

CONCLUSIONS

Patients with TB present with a considerable number of clinically important pDDIs and ADEs (particularly hepatotoxicity). TB patients should be monitored for adverse effects of anti-TB drugs. Attention should be given to major-pDDIs. Patients more at risk to interactions should be identified and monitored for related adverse outcomes.