Ocular adverse events in drug sensitive TB patients on daily fixed dose combination anti-TB drugs: A record review study from Kerala, India
Authors
Manu, MSMehta, K
Das, M
Balakrishnan, S
Sunil Kumar, M
Rakesh, PS
Sindhu, MP
Valamparampil, MJ
Neena, PS
Satyanarayana, S
Issue Date
2020-02-27Submitted date
2020-07-17
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BACKGROUND:Government of India's Revised National TB Control Programme (RNTCP) has begun implementing daily fixed dose combination (FDC) anti-TB treatment regimen for drug sensitive TB patients in which ethambutol is given for six months. Prolonged ethambutol use is known to cause ocular adverse drug events (ADE). OBJECTIVES:To assess the magnitude of ocular ADEs in adult drug sensitive TB patients initiated on daily FDCs and to describe the demographic and clinical profile of patients with ocular ADEs. METHODS:We conducted a retrospective cohort study involving review of RNTCP records of all adult (age >14 years) drug sensitive TB patients initiated on daily FDCs between1st January 2018 and 31st July 2018 in Thiruvananthapuram district, Kerala State, India. RESULTS:714 patients were initiated on daily FDCs during the study period. It was unknown whether all patients had undergone assessment for ocular ADEs. However, of these 714 patients, 8 patients (1.1%) were documented to have had ocular ADEs. Seven of these 8 patients had received ethambutol more than 15 mg/kg body weight and had developed ocular symptoms (decreased/blurring of vision) 3 months after TB treatment initiation. Ethambutol was stopped in all these 8 patients. In 5 patients it was recorded that ocular ADEs had resolved following stoppage of ethambutol and in the remaining it was unknown. CONCLUSION:The study confirms the occurrence of ocular ADEs among drug sensitive TB patients on daily FDCs and recommends strengthening of systems for assessing, documenting and managing ocular ADE.Publisher
ElsevierPubMed ID
32553315Type
ArticleLanguage
enDescription
We regret this article is behind a paywall.ISSN
0019-5707ae974a485f413a2113503eed53cd6c53
10.1016/j.ijtb.2020.02.008
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