What question did this study set out to answer?

To assess the frequency, severity, and resolution of adverse drug reactions in patients receiving new and repurposed regimens for drug-resistant tuberculosis under active pharmacovigilance.

October 10, 2019European Respiratory JournalOpen Access

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

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Authors

BSBorisov SeRussian Academy of Sciences EDEdvardas DanilaVilnius University AMAndrei MaryandyshevNorthern State Medical University

Discussion

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Implication

Prospective cohort study observes adverse event rates in drug-resistant tuberculosis, indicating manageable safety profiles for new and repurposed regimens.

Key Points

To assess the frequency, severity, and resolution of adverse drug reactions in patients receiving new and repurposed regimens for drug-resistant tuberculosis under active pharmacovigilance.
Prospective international cohort study conducted across 45 centres in 26 countries/regions involving 658 patients with drug-resistant tuberculosis.
Tracked adverse events linked to specific drugs—including bedaquiline (87.7%), delamanid (18.4%), linezolid (81.5%), and clofazimine (32.4%)—alongside clinical and bacteriological data.
Classified adverse event severity from grade 1 to grade 5 using the World Health Organization active drug safety monitoring framework.
A total of 504 adverse events occurred, with 88.7% (447/504) graded as minor (grade 1–2) and 11.3% (57/504) classified as serious (grade 3–5).
Most serious adverse events resolved (89.5%, 51/57), while responsible drugs were discontinued in 0.35% of bedaquiline recipients (2/577), 0.8% of delamanid recipients (1/121), 1.9% of linezolid recipients (10/536), and 1.4% of clofazimine recipients (3/213).
Serious adverse events occurred in 6.9% of patients receiving amikacin (9/131), 2.8% with linezolid (15/536), 1.8% with cycloserine/terizidone (8/498), and 0.4% with ethionamide/prothionamide (1/221).

Cite This Study

Se et al. (2019) studied this question.

synapsesocial.com/papers/69dabaacaae38ff6ad836255 https://doi.org/10.1183/13993003.01522-2019

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Implication

Prospective cohort study observes adverse event rates in drug-resistant tuberculosis, indicating manageable safety profiles for new and repurposed regimens.

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

Discussion

Member takes

Implication

Key Points

Cite This Study

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

Discussion

Member takes

Implication

Key Points

Cite This Study

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