DOI: http://dx.doi.org/10.18203/2349-3933.ijam20212777

Frequency and type of adverse drug reactions related to multidrug-resistant tuberculosis therapy

Afaq Ahmed, Ashok Kumar Gudagunti, Shylendra ., Veena Hagalur Nayak, H. Mallikarjun Swamy

Abstract


Background: Adverse drug reactions (ADRs) are inevitable consequences of multidrug-resistant tuberculosis drug therapy. Reporting of ADR in India is poor and inadequate. ADRs monitoring forms an integral part of pharmacovigilance. ADRs with second line anti-tuberculous therapy (ATT) have been mentioned as obstacles in the management of multidrug-resistant tuberculosis (MDR-TB). Objectives of the study was to study the frequency and type of adverse drug reaction related to MDR-TB therapy.

Methods: 72 patients diagnosed as MDR-TB and enrolled for DOTS-PLUS (CAT.IV) regimen at NTEP centre, KIMS HUBLI were included. This was a prospective observational study. All patients were followed up for a period of 9 months from the day of commencement of treatment. Adverse drug reactions were determined by monthly clinical and biochemical monitoring of patients to identify ADRs.

Results: Among 72 Patients, 42 (58.3%) were males. 44 out of 72 patients experienced at least one type of ADRs (61.1%). Mean age was 35.86±12.62 and mean weight was 42.00±9.05. Four most common ADRs reported were Gastro-intestinal symptoms (29.2%), anorexia (15.3%), giddiness (12.5%), and pain at injection site (11.1%). Highest percentage of ADRs were seen in patients of age group>60 years (66.7%). ADRs were most commonly reported in first 3 months of initiation of therapy. 9 out of 72 patients (12.5%) or 20.5% of 44 patients who showed ADRs required change of treatment. There was a significant impact of ADRs on treatment among those with ADRs (p=0.01).

Conclusion: ADRs of varying severity are common in patients of MDR-TB on DOTS-PLUS regimen, occurring in more than half of the cases, with around one fifth requiring change of MDR-TB treatment.


Keywords


MDR-TB, ADRs, DOTS-PLUS

Full Text:

PDF

References


Tripathi KD. Adverse drug reactions. In: Essentials of Medical Pharmacology. 7thed. New Delhi: Jaypee. 2013;82.

Hutchinson TA, Flegel KM, Kramer MS, Leduc DG, Kong HH. Frequency, severity and risk factors for adverse drug reactions in adult out-patients: a prospective study. J Chronic Dis. 1986;39:533-42.

Hanlon JT, Schmader KE, Koronkowski MJ, Weinberger M, Landsman PB, Samsa GP et al. Adverse drug events in high-risk older outpatients. J Am Geriatr Soc. 1997;45:945-8.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. A meta-analysis of prospective studies. J Am Med Assoc. 1998;279:1200-05.

Classen DC, Pestotnik SL, Scott Evans R, Lloyd JF, Burke JP. Adverse drug reactions in hospitalized patients. J Am Med Assoc. 1997;277:301-6.

WHO. Global Tuberculosis Control: WHO Report. WHO Document WHO/CDS/TB, Geneva, Switzerland; 2012. Available at: https://www.who. int/tb/publications/global_ report/gtbr12_main.pdf. Accessed on 15th July 2015.

WHO. Global Tuberculosis Report 2014-Drug Resistant TB: Surveillance and Response. 2014. Available at: https://apps.who.int/iris/handle/ 10665/137095. Accessed on 15th July 2015.

Ramachandran R, Nalini S, Chandrasekar V, Dave PV, Sanghvi AS, Wares F et al. Surveillance of drug-resistant tuberculosis in the state of Gujarat, India. Int J Tuberc Lung Dis. 2009;13(9);1154-60.

Central TB Division (CTD), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. DOTS-Plus Guidelines. CTD, New Delhi. 2012.

Baghaei P, Tabarsi P, Dorriz D, Marjani M, Shamaei M, Pooramiri V et al. Adverse effects of multidrug-resistant tuberculosis treatment with a standardized regimen: report from Iran. Am J Ther. 2011;18:e29-34.

Rosenbaum DSF. Clinical Research Monitor Handbook: GCP Tools and Techniques, 2nd ed. Boca Raton: CRC Press. 1998.

Shin SS, Pasechnikov AD, Gelmanova IY, Peremitin GG, Strelis AK, Mishustin S et al. Adverse Reactions among Patients Being Treated for MDR-TB in Tomsk, Russia. The Int J Tuberculosis Lung Dis. 2007;11:1314-20.

Wu S, Zhang Y, Sun F, Chen M, Zhou L, Wang N et al. Adverse Events Associated with the Treatment of Multidrug-Resistant Tuberculosis: A Systematic Review and Meta-analysis. Am J Ther. 2016;23(2):e521-30.

Hire R, Kale AS, Dakhale GN, Gaikwad N. 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):19-25.

Torun T, Gungor G, Ozmen I, Bolukbasi Y, Maden E, Bicakci B et al. Side effects associated with the treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2005;9:1373-7.

Avong YK, Isaakidis P, Hinderaker SG, Van den Bergh R, Ali E, Obembe BO et al. Doing No Harm? Adverse Events in a Nation-Wide Cohort of Patients with Multidrug-Resistant Tuberculosis in Nigeria. PLoS ONE. 2015;10(3):e0120161.

World Health Organization, Global Tuberculosis Report. 2014. Available at: https://www.who.int/ tb/publications/global_report/gtbr14_main_text.pdf. Accessed on 15th July 2015.

Diwan V, Thorson A. Sex, gender, and tuberculosis. Tuberculosis. 1999;353(9157):1000-1.

Thorson A, Diwan VK. Gender inequalities in tuberculosis: aspects of infection, notification rates, and compliance, Curr Opin Pulm Med. 2001;7(3):165-9.

Sagwa E, Mantel-Teeuwisse A, Ruswa N, Musasa JP, Pal S, Dhliwayo P et al. The burden of adverse events during treatment of drug-resistant tuberculosis in Namibia, South. Med Rev. 2012;5(1):6-13.

Isaakidis P, Varghese B, Mansoor H, Cox HS, Ladomirska J. Adverse events among HIV/MDR-TB co-infected patients receiving antiretroviral and second line anti-TB treatment in Mumbai, India, PLoS ONE. 2012;7(7):e40781.

Bezu H, Seifu D, Yimer G, Mebrhatu T. Prevalence and Risk Factors of Adverse Drug Reactions Associated Multidrug Resistant Tuberculosis Treatments in Selected Treatment Centers in Addis Ababa Ethiopia. J Tuber Res. 2014;2:144-54.

Kapadia VK, Tripathi SB. Adverse Drug Reactions and Outcome Analysis of MDR TB Patients on DOTS Plus Regimen. Ntl J Com-munity Med. 2015;7(1):5-9.

World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis. Interim policy guidance. Available at: http://apps.who.int/iris/bitstream/handle/10665/254712/WHO-HTM-TB-2017.01-eng.pdf;jsessionid=01C2BD3FCB95C36D8F68B11391F57649?sequence=1. Accessed on November 2009.

World Health Organization. Guidelines for the programmatic management of drug-resistant tuberculosis. WHO/HTM/TB/2006.361. Geneva, Switzerland: WHO, 2006. Available at: http://whqlibdoc.who.int/publications/2006/9241546956_eng.pdf. Accessed on November 2009.

Furin JJ, Mitnick CD, Shin SS, Bayona J, Becerra MC, Singler JM et al. Occurrence of serious adverse effects in patients receiving community-based therapy for multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2001;5:648-55.