Published: 2015-10-22

Adverse events among patients of multi drug resistant tuberculosis receiving second line anti TB treatment

Kishor B. Rathod, Mangala S. Borkar, Avinash R. Lamb, Sanjay L. Suryavanshi, Gajanan A. Surwade, Vimlesh R. Pandey


Background: As per WHO’s “Global Tuberculosis Report, 2012”, India accounts for an estimated 64000 patients out of 310000 cases of drug resistant TB estimated to have occurred amongst the notified cases of TB across the globe in a year.  MDR-TB is a man-made phenomenon– poor treatment; poor drugs, poor adherence lead to the development of MDR-TB.  Treatment of MDR-TB is difficult, much costlier, challenging and needs experience and skills. Reserve drugs are frequently associated with high rates of unacceptable adverse drug reactions, needing change of regimen. Therefore, it is imperative to monitor and treat adverse drug reactions.

Methods: The present prospective observational study was carried out at Drug Resistant Tuberculosis Centre at Govt. Medical College, Aurangabad, Maharashtra, to monitor patients for early detection of adverse events after starting treatment till the patients were admitted and later followed up personally or telephonically at regular intervals.

Results: We observed adverse drug reactions among 90/265 (33.96 %) patients of whom 90/265 (33.96 %) had gastro intestinal ADRs, followed by ototoxicity 15/265 (5.66%), psychiatric manifestations 14/265 (5.28%), injection site pain swelling 13/265 (4.90%), arthralgia 11/265 (4.15%), dermatological ADRs 7/265 (2.64%), peripheral neuropathy 5/265 (1.88%), renal dysfunction 3/265 (1.13%), change of therapy was only required in 13 psychiatric and 12 ototoxic ADRs.

Conclusions: ADRs are more common in MDR TB patients on second line anti tubercular treatment. Good counseling, spacing drugs, high protein diet helps patients to tolerate therapy better and default rate to drop.


MDR-TB (Multidrug resistant tuberculosis), ADR (Adverse drug reaction), Second line anti TB drugs

Full Text:



Central TB Division. Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India; New Delhi. Guidelines on programmatic management of drug resistant TB (PMDT) in India. New Delhi: Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India; May 2012.

Pauline Joseph, Vijaya Bhaskara Rao Desai, Nalini Sunder Mohan, Jemima Sheila Fredrick, Rajeswari Ramachandran, Balambal Raman, et al. Outcome of standardized treatment for patients with MDR-TB from Tamil Nadu, India. Indian J Med Res. 2011 May;133(5):529-34.

V. K. Arora, R. Sarin, R. Singla, U. K. Khalid, K. Mathuria, Neeta Singla, et al. DOTS-plus for patients with multidrug-resistant tuberculosis in India: early results after three years. Indian J Chest Dis Allied Sci. 2007;49:75-80.

Singla R, Al-Sharif N, Al-Sayegh MO, Osman MM, Shaikh MA. Influence of anti-tuberculosis drug resistance on the treatment outcome of pulmonary tuberculosis patients receiving DOTS in Riyadh, Saudi Arabia. Int J Tuberc Lung Dis. 2002;6:585-91.

Prasad R. Management of multi-drug resistant tuberculosis: practitioner’s view point. Indian J Tuberc. 2007;54:3-11.

Singla R, Sarin R, Khalid UK, Mathuria K, Singla N, Jaiswal A 3rd, et al. Seven-year DOTS-plus pilot experience in India: results, constraints and issues. Int J Tuberc Lung Dis. 2009;13:976-81.

Singh R, Gothi D, Joshi JM. Multidrug resistant tuberculosis: role of previous treatment with second line therapy on treatment outcome. Lung India. 2007;24:54-7.

Rohan Hire, A. S. Kale, G. N. Dakhale, Nilesh Gaikwad. A prospective, observational study of adverse reactions to drug regimen for multi-drug resistant pulmonary tuberculosis in Central India. Mediterr J Hematol Infect Dis. 2014;6(1):e2014061.

Bikram Singh Datta, Ghulam Hassan, Syed Manzoor Kadri, Waseem Qureshi, Mustadiq Ahmad Kamili, Hardeep Singh, et al. Multidrug-Resistant and extensively drug resistant tuberculosis in Kashmir. India J Infect Dev Ctries. 2010;4(1):019-023.

Kalpesh Jain, Mira Desai, Ram Kumar Dikshit. Treatment outcome of standardized regimen in patients with multidrug resistant tuberculosis. J Pharmacol Pharmacother. 2014 Apr-Jun;5(2):145-9.

Kapadia Vishakha K, Tripathi Sanjay B. Analysis of 63 patients of MDR TB on DOTS plus regimen: an LG hospital, TB Unit, Ahmadabad experience. Guj Med J. 2013 Dec;68(2):052-7.

Bloss E, Kukša L, Holtz TH, Riekstina V, Skripcˇonoka V, Kammerer S, et al. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000-2004. Int J Tuberc Lung Dis. 2010 Mar;14(3):275-81.