ADVERSE DRUG REACTION: A STUDY WITH FIRST- AND SECOND-LINE ANTI-TB DRUGS AT TERTIARY CARE WITH NODAL DRTB CENTER

Introduction: Adverse Drug Reactions (ADR) is unwanted, uncomfortable, or harmful responses to drugs, which may occur even when the drug is used at a standard therapeutic dose. In the context to tuberculosis (TB) treatment, the ADRs are a significant challenge, especially in high-burden countries like India, where drug-resistant TB (DRTB) is on the rise. The ADR is one of the major causes of treatment interruption that ultimately lead to poor outcome. The ADR management is crucial and requires know how of mechanism of the drug action, interaction, timely identification with stratification of ADR and pre existing dysfunction of the organ or system due to co-morbidities.

Results: The 13% (84/647) of the causes of ADR and three times more i.e. 40% (76/168) cases of ADR were observed among treatment with first and second line anti TB drugs respectively. Most of the ADR developed during intensive phase of treatment. The hepatotoxicity (35%) followed by peripheral neuritis and GI disturbances etc were the common ADR and recovery period and out comes remained satisfactory. However 5 % of the patients did not improve from peripheral neuritis. The PZA and Linezolid remained at the top of the culprit drug list, and the COPD (43%) followed by DM (14%) and hepatic ailment (13%) etc observed as associated co morbidities.

Discussion: The TB patient with lower BMI (51%) were more vulnerable to ADR may be due to under nourishment/ malabsorption or poor immunity. Three times more ADR among SLDs could be due to use of repurposed drugs like linezolid and clofazimine, and new drugs bedaquiline and delamanid. The recovery from ADR remained satisfactory in our study but somehow 4 (5%) not recover due to peripheral neuritis and associated co morbidity and extensive parenchymal disease. A prompt reporting or detection and quick management with drug withdrawal/ dose reduction and proper replacement of drug improves the treatment outcomes. However there is hope that the BPaLM regimen having only four drugs for six month period with promising reviews of decreased ADRs is most likely to change TB scenario in coming future. However it iswise to carrying on with the treatment plan if the side effect is minor and not life-threatening with counselling, assurance and psychological support to the patient.

Conclusion: ADR is an untoward/unwanted/ or undesirable exaggerated drug action so it become mandatory to understand about 1) Common drug adverse effectspresentations 2) Pharmo kinetic and dynamic action of individual drug in used 3) Drug interaction 4) Existing co morbidities and 5) immunological status of the host. None of the drug is absolutely free from adverse event.