Adverse Drug Reactions with First-Line and Second-Line Drugs in Treatment of Tuberculosis

Rajendra Prasad; Abhijeet Singh; Nikhil Gupta

doi:10.1055/s-0040-1722535

Annals of the National Academy of Medical Sciences (India), Inhaltsverzeichnis

CC BY-NC-ND 4.0 · Ann Natl Acad Med Sci 2021; 57(01): 15-35
DOI: 10.1055/s-0040-1722535

Review Article

Adverse Drug Reactions with First-Line and Second-Line Drugs in Treatment of Tuberculosis

Rajendra Prasad

¹Department of Pulmonary Medicine, Era’s Lucknow Medical College and Hospital, Lucknow, Uttar Pradesh, India

,

Abhijeet Singh

²Department of Pulmonary and Critical Care Medicine, Medeor JCS Institute of Pulmonary, Critical Care and Sleep Medicine, New Delhi, India

,

Nikhil Gupta

³Department of General Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India

› Institutsangaben

Abstract

Drug-susceptible tuberculosis (DS-TB) requires treatment with first-line drugs (FLDs) whereas drug-resistant TB (DR-TB) are treated with combination of second-line drugs (SLDs) and fewer FLDs. Adverse drug reactions (ADRs) to these drugs are quite evident as they are being used for longer duration. The overall prevalence of ADRs with FLDs and SLDs are estimated to vary from 8.0 to 85 and 69 to 96%, respectively. Most ADRs are observed in the intensive phase as compared to continuation phase. Major concerns exist regarding treatment of DR-TB patients, especially with SLDs having lower efficacy more toxicity and high cost as compared to FLDs. A variety of ADRs may be produced by anti-TB drugs ranging from mild or minor to severe or major like gastrointestinal toxicity (nausea/vomiting, diarrhoea, and hepatotoxicity), ototoxicity, neurotoxicity (peripheral neuropathy and seizures), nephrotoxicity, cutaneous toxicity, and cardiotoxicity. Most of ADRs are minor and can be managed without discontinuation of treatment. Few ADRs’ can be major causing life-threatening experience leading to either modification or discontinuation of regimen and even mortality. A careful monitoring of ADRs during the treatment with anti-TB drugs and early recognition and appropriate management of these ADRs might improve adherence leading to favorable outcome.

Keywords

tuberculosis - adverse drug reactions - drug-resistant TB - drug-sensitive TB - first-line drugs - second-line drugs - anti-TB drugs

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References
1 World Health Organization. Global tuberculosis report 2019. WHO, Geneva, 2019 (WHO/CDS/TB/2019.15). Available at: https://www.who.int/tb/publications/global_report/en/. Accessed June 28, 2020
2 World Health Organization. Requirements for Adverse Reaction Reporting. Geneva, Switzerland: World Health Organization 1975
3 Forget EJ, Menzies D. Adverse reactions to first-line antituberculosis drugs. Expert Opin Drug Saf 2006; 5 (02) 231-249
4 Gülbay BE, Gürkan Ö, Yildiz Ö. et al. Side effects due to primary antituberculosis drugs during the initial phase of therapy in 1149 hospitalized patients for tuberculosis. J Respir Med 2006; 100: 1834-1842
5 Tan WC, Ong CK, Kang SC, Razak MA. Two years review of cutaneous adverse drug reaction from first line anti-tuberculous drugs. Med J Malaysia 2007; 62 (02) 143-146
6 Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356 (9237) 1255-1259
7 Singh A, Prasad R, Balasubramanian V, Gupta N, Gupta P. Prevalence of adverse drug reaction with first-line drugs among patients treated for pulmonary tuberculosis. Clin Epidemiol Glob Health 2015; 3: s80-s90
8 Marra F, Marra CA, Bruchet N. et al. Adverse drug reactions associated with first-line anti-tuberculosis drug regimens. Int J Tuberc Lung Dis 2007; 11 (08) 868-875
9 Butov D, Kuzhko M, Stepanenko G, Butova T. Frequency of adverse reactions to first-line anti-tuberculosis chemotherapy in patients with relapse (RTB) and newly diagnosed tuberculosis (NDTB). European Respiratory Journal 2018; 52 (s62 PA2700
10 Dosumu EA. Side-effects of drugs used in directly observed treatment short-course in newly diagnosed pulmonary tuberculosis subjects in Nigerians: a controlled clinical study. Niger Postgrad Med J 2002; 9 (01) 34-37
11 Arbex MA, Varella MdeC, Siqueira HR, Mello FA. Antituberculosis drugs: drug interactions, adverse effects, and use in special situations. Part 1: first-line drugs. J Bras Pneumol 2010; 36 (05) 626-640
12 Vieira DE, Gomes M. Adverse effects of tuberculosis treatment: experience at an outpatient clinic of a teaching hospital in the city of São Paulo, Brazil. J Bras Pneumol 2008; 34 (12) 1049-1055
13 Breen RA, Miller RF, Gorsuch T. et al. Adverse events and treatment interruption in tuberculosis patients with and without HIV co-infection. Thorax 2006; 61 (09) 791-794
14 Mwandumba HC, Squire SB. Fully intermittent dosing with drugs for treating tuberculosis in adults. Cochrane Database Syst Rev 2001; (04) CD000970
15 Mehrotra ML. Agra study of short course chemotherapy in pulmonary tuberculous patients. Indian J Tuberc 1982; 29: 29-39
16 Dedun AR, Borisagar GB, Solanki RN. Impact of adverse drug reaction of first line anti - tuberculous drugs on treatment outcome of tuberculosis under revised national tuberculosis control programme. International Journal of Advances in Medicine 2017; 4: 645-649
17 Naser SM, Nandy M, Banu P. et al. Adverse drug reaction monitoring through active surveillance of antitubercular therapy in an urban tertiary care center. Community Acquir Infect 2016; 3: 51-54
18 Mandal PK, Mandal A, Bhattacharyya SK. Comparing the daily versus the intermittent regimens of the anti-tubercular chemotherapy in the initial intensive phase in non-HIV, sputum positive, pulmonary tuberculosis patients. J Clin Diagn Res 2013; 7 (02) 292-295
19 Prasad R, Singh A, Gupta N, Giridhar BH. Epidemiology of adverse drug reaction with second line drugs among patients treated for multi- drug resistant tuberculosis. European Journal of Biomedical and Pharmaceutical Sciences 2015; 2: 553-561
20 Wu S, Zhang Y, Sun F. et al. Adverse events associated with the treatment of multidrug-resistant tuberculosis: a systematic review and meta-analysis. Am J Ther 2016; 23 (02) e521-e530
21 Schnippel K, Firnhaber C, Berhanu R, Page-Shipp L, Sinanovic E. Adverse drug reactions during drug-resistant TB treatment in high HIV prevalence settings: a systematic review and meta-analysis. J Antimicrob Chemother 2017; 72 (07) 1871-1879
22 Nathanson E, Gupta R, Huamani P. et al. Adverse events in the treatment of MDR-TB: results from the DOTS-Plus initiative. Int J Tuberc Lung Dis 2005; 9: 1027-1033
23 Baghaei P, Tabarsi P, Dorriz D. et al. Adverse effects of multidrug-resistant tuberculosis treatment with a standardized regimen: a report from Iran. Am J Ther 2011; 18: e29-e34
24 Singla R, Sarin R, Khalid UK. et al. Seven-year DOTS-Plus pilot experience in India: results, constraints and issues. Int J Tuberc Lung Dis 2009; 13 (08) 976-981
25 Joseph P, Desai VB, Mohan NS. et al. Outcome of standardized treatment for patients with MDR-TB from Tamil Nadu, India. Indian J Med Res 2011; 133: 529-534
26 Isaakidis P, Varghese B, Mansoor H. et al. Adverse events among HIV/MDR-TB co-infected patients receiving antiretroviral and second line anti-TB treatment in Mumbai, India. PLoS One 2012; 7 (07) e40781
27 Dela AI, Tank NKD, Singh AP, Piparva KG. Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: a four year retrospective study. Lung India 2017; 34 (06) 522-526
28 Prasad R, Singh A, Srivastava R. et al. Adverse drug reaction in the treatment of multi drug resistant tuberculosis. Indian J Tuberc 2013; 144 (Suppl. 04) 390A
29 Shinde KM, Pore SM, Bapat TR. Adverse reactions to first-line anti-tuberculous agents in hospitalised patients: pattern, causality, severity and risk factors. Indian J Med Spec 2013; 4: 1-4
30 Lv X, Tang S, Xia Y. et al. Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study. PLoS One 2013; 8 (06) e65037
31 Anand AC, Seth AK, Paul M, Puri P. Risk factors of hepatotoxicity during anti-tuberculosis treatment. Med J Armed Forces India 2006; 62 (01) 45-49
32 Parthasarathy R, Sarma GR, Janardhanam B. et al. Hepatic toxicity in South Indian patients during treatment of tuberculosis with short-course regimens containing isoniazid, rifampicin and pyrazinamide. Tubercle 1986; 67 (02) 99-108
33 Blumberg HM, Burman WJ, Chaisson RE. et al. American Thoracic Society, Centers for Disease Control and Prevention and the Infectious Diseases Society. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: treatment of tuberculosis. Am J Respir Crit Care Med 2003; 167 (04) 603-662
34 Steele MA, Burk RF, DesPrez RM. Toxic hepatitis with isoniazid and rifampin. A meta-analysis. Chest 1991; 99 (02) 465-471
35 Pande JN, Singh SPN, Khilnani GC, Khilnani S, Tandon RK. Risk factors for hepatotoxicity from antituberculosis drugs: a case-control study. Thorax 1996; 51 (02) 132-136
36 Baghaei P, Tabarsi P, Chitsaz E. et al. Incidence, clinical and epidemiological risk factors, and outcome of drug-induced hepatitis due to antituberculous agents in new tuberculosis cases. Am J Ther 2010; 17 (01) 17-22
37 Prasad R, Verma SK, Chowdhury SR, Chandra M. Predisposing factors in hepatitis induced by anti-tuberculosis regimens containing isoniazid, rifampicin and pyrazinamide: a case control study. JIMI 2006; 9: 73-78
38 Lee AM, Mennone JZ, Jones RC, Paul WS. Risk factors for hepatotoxicity associated with rifampin and pyrazinamide for the treatment of latent tuberculosis infection: experience from three public health tuberculosis clinics. Int J Tuberc Lung Dis 2002; 6 (11) 995-1000
39 Kumar R, Bhatia V, Khanal S. et al. Shalimar. Antituberculosis therapy-induced acute liver failure: magnitude, profile, prognosis, and predictors of outcome. Hepatology 2010; 51 (05) 1665-1674
40 British Thoracic Association. A comparison of the toxicity of prothionamide and ethionamide: a report from the research committee of the British Tuberculosis Association. Tubercle 1968; 49 (02) 125-135
41 DR-TB STAT (Drug-Resistant TB Scale-Up Treatment Action Team). Treatment of Drug-Resistant TB with New and Re-Purposed Medications: a Field Guide. Cleveland, DR-TB STAT, 2018; 1-55. Accessed at: http://drtb-stat.org/
42 Chhetri AK, Saha A, Verma SC, Palaian S, Mishra P, Shankar PR. Study of adverse drug reactions caused by first line anti-tubercular drugs used in directly observed treatment, short course (DOTS) therapy in Western Nepal, Pokhara. J Pak Med Assoc 2008; 58 (10) 531-536
43 Philadelphia Tuberculosis Control Program. Guidelines for the Management of Adverse Drug Effects of Anti-mycobacterial Agents. Available at: https://medbox.org/pdf/5e148832db60a2044c2d3f51. Accessed December 11, 2020
44 Prasad R, Garg R, Verma SK. Isoniazid- and ethambutol-induced psychosis. Ann Thorac Med 2008; 3 (04) 149-151
45 Jackson SL. Psychosis due to isoniazid. BMJ 1957; 2 (5047) 743-746
46 Kass JS, Shandera WX. Nervous system effects of antituberculosis therapy. CNS Drugs 2010; 24 (08) 655-667
47 Tsai RK, Lee YH. Reversibility of ethambutol optic neuropathy. J Ocul Pharmacol Ther 1997; 13 (05) 473-477
48 Leibold JE. The ocular toxicity of ethambutol and its relation to dose. Ann N Y Acad Sci 1966; 135 (02) 904-909
49 Tang S, Yao L, Hao X. et al. Efficacy, safety and tolerability of linezolid for the treatment of XDR-TB: a study in China. Eur Respir J 2015; 45 (01) 161-170
50 Moore RD, Smith CR, Lietman PS. Risk factors for the development of auditory toxicity in patients receiving aminoglycosides. J Infect Dis 1984; 149 (01) 23-30
51 Prazić M, Salaj B. Ototoxicity with children caused by streptomycin. Audiology 1975; 14 (02) 173-176
52 Berte SJ, Dimase JD, Christianson CS. Isoniazid, para-aminosalicylic acid and streptomycin intolerance in 1,744 patients. An analysis of reactions to single drugs and drug groups plus data on multiple reactions, type and time of reactions, and desensitization. Am Rev Respir Dis 1964; 90: 598-606
53 Rybak MJ, Abate BJ, Kang SL, Ruffing MJ, Lerner SA, Drusano GL. Prospective evaluation of the effect of an aminoglycoside dosing regimen on rates of observed nephrotoxicity and ototoxicity. Antimicrob Agents Chemother 1999; 43 (07) 1549-1555
54 Garg R, Gupta V, Mehra S, Singh R, Prasad R. Rifampicin induced thrombocytopenia. Indian J Tuberc 2007; 54 (02) 94-96
55 Prasad R, Mukerji PK. Rifampicin induced thrombocytopenia. Indian J Tuberc 1989; 36: 171-175
56 Prasad R, Mukerji PK. Ethambutol-induced thrombocytopaenia. Tubercle 1989; 70 (03) 211-212
57 Kant S, Verma SK, Gupta V, Anand SC, Prasad R. Pyrazinamide induced thrombocytopenia. Indian J Pharmacol 2010; 42 (02) 108-109
58 Sotgiu G, Centis R, D’Ambrosio L. et al. Efficacy, safety and tolerability of linezolid containing regimens in treating MDR-TB and XDR-TB: systematic review and meta-analysis. Eur Respir J 2012; 40 (06) 1430-1442
59 Gerdan V, Akkoc N, Ucan ES, Bulac Kir S. Paradoxical increase in uric acid level with allopurinol use in pyrazinamide-induced hyperuricaemia. Singapore Med J 2013; 54 (06) e125-e126
60 Postlethwaite AE, Bartel AG, Kelley WN. Hyperuricemia due to ethambutol. N Engl J Med 1972; 286 (14) 761-762
61 Kang BH, Jo KW, Shim TS. Current status of fluoroquinolone use for treatment of tuberculosis in a tertiary care hospital in Korea. Tuberc Respir Dis (Seoul) 2017; 80 (02) 143-152
62 Pym AS, Diacon AH, Tang SJ. et al. TMC207-C209 Study Group. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J 2016; 47 (02) 564-574
63 Rougier F, Claude D, Maurin M. et al. Aminoglycoside nephrotoxicity: modeling, simulation, and control. Antimicrob Agents Chemother 2003; 47 (03) 1010-1016
64 de Jager P, van Altena R. Hearing loss and nephrotoxicity in long-term aminoglycoside treatment in patients with tuberculosis. Int J Tuberc Lung Dis 2002; 6 (07) 622-627
65 Yang TW, Park HO, Jang HN. et al. Side effects associated with the treatment of multidrug-resistant tuberculosis at a tuberculosis referral hospital in South Korea: A retrospective study. Medicine (Baltimore) 2017; 96 (28) e7482
66 Tawanda G. Chemotherapy of tuberculosis, Mycobacterium avium complex disease and leprosy. In: Brunton LL, Chabner BA, Knollman B, eds. Goodman and Gilman’s: The Pharmacological Basis of the Therapeutics. 12th ed. New York, USA: McGraw Hill Med 2011: 1559
67 Garg R, Verma S, Mahajan V, Prasad R. Exfoliative dermatitis secondary to ethambutol and pyrazinamide. Internet J Pulm Med 2008; 9 (01) 1-4
68 Potter JL, Capstick T, Ricketts WM, Whitehead N, Kon OM. A UK-based resource to support the monitoring and safe use of anti-TB drugs and second-line treatment of multidrug-resistant TB. Thorax 2015; 70 (03) 297-298
69 Pontali E, Sotgiu G, Tiberi S, D’Ambrosio L, Centis R, Migliori GB. Cardiac safety of bedaquiline: a systematic and critical analysis of the evidence. Eur Respir J 2017; 50 (05) 1701462
70 Garg R Vaibhav, Mehra S, Prasad R. Isoniazid induced gynaecomastia: a case report. Indian J Tuberc 2009; 56 (01) 51-54
71 Prasad R. Anaphylactic shock due to streptomycin sulphate. J Indian Med Assoc 1984; 82 (07) 254-255
72 WHO. A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis. Available at: https://www.who.int/docs/default-source/documents/tuberculosis/a-practical-handbook-on-the-pharmacovigilance-of-medicines-used-in-the-treatment-of-tuberculosis.pdf?sfvrsn=6e5fc0cf_5. Accessed December 11, 2020
73 Division of AIDS, National Institute of Allergy and Infectious Diseases. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected version 2.1. Available at: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf. Accessed December 11, 2020
74 World Health Organization. WHO consolidated guidelines on drug-resistant tuberculosis treatment. Available at: https://apps.who.int/iris/bitstream/handle/10665/311389/9789241550529-eng.pdf?ua=1. Accessed December 11, 2020
75 Prasad R, Gupta N. Handbook on Adverse Drug Reactions in TB treatment. 1st ed. Delhi, India: Jaypee Brothers Medical Publishers 2019