Adverse Drug Reactions in Multi-Drug Resistant Tuberculosis Patients, in India, who had received DOTS Plus Treatment along with Home Care and Counselling

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Joyce Felicia Vaghela


Background: Adverse drug reactions are common in MDR-TB patients on treatment. An adverse drug reaction (ADR) is defined as an appreciably harmful or unpleasant reaction resulting from an intervention related to the use of a medicinal product. Revised National Tuberculosis Control Programme used 24-months long Category IV/DOTS Plus regimen for treatment of MDR-TB.

The Community Health Department of St. Stephen’s Hospital started an innovative project in 2009, in the form of Home Care for MDR Patients and it concluded with Long-term Follow-up of patients, who had received DOTS Plus Treatment along with Home Care and Counselling (2015).

Aims: To study the spectrum, severity and the risk factors for ADRs in MDR-TB patients.

Methods: In this retrospective study files of 109 MDR-TB patients who had received treatment along with home care and counselling support, were reviewed. The study was conducted between January to May 2024.

Results: Out of 109 MDR TB patients there were 68 (62%) developed one or more ADR. Joint pains 44(40.36%), was the most commonly observed ADR, followed by nausea 29(26.6%) and vomiting 25(22.93%), weakness 23(21.1%), anxiety and depression 16(14.67%), difficulty in breathing 14(12.84%), tremors 13(11.9%), giddiness 11(10.1%), skin rashes 10(9.2%).

According to Hartwig Scale mild ADRs were 58.8%, moderate 5.9% and severe 35.3%. Patients who had BMI <18.5 experienced less ADRs with an Odds Ratio =0.22; 95% CI=0.06 to 0.72, p=0.0124. Unemployment was associated with higher number of ADRs OR=3.5; 95% CI=0.99 to 12.29, p=0.05.

Sixty-two % MDR TB patients had ADRs. Our treatment outcomes showed 41(60.3) as cured, 24(35.3) died, 2(2.9) defaulted and 1(1.5) failed treatment. This was possible because healthcare teams counselled and provided all possible support to patients 24x7 thus improving adherence to therapy.

Conclusion: ADRs occurred in more than half of the cases, with joint pain being the most common. Interventions such as counselling of patients and their family on importance of adherence to drugs at the initiation of treatment, provision of nutritional support, psychological counselling and motivation, instant referral for ADRs and care of patients at referred facilities, help patients not becoming defaulters.

Keywords: Adverse Drug Reactions, DOTS Plus, Multidrug-Resistant Tuberculosis

Article Details

How to Cite
VAGHELA, Joyce Felicia. Adverse Drug Reactions in Multi-Drug Resistant Tuberculosis Patients, in India, who had received DOTS Plus Treatment along with Home Care and Counselling. Medical Research Archives, [S.l.], v. 12, n. 6, june 2024. ISSN 2375-1924. Available at: <>. Date accessed: 22 july 2024. doi:
Research Articles


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