Impact of adverse drug reaction of first line anti - tuberculous drugs on treatment outcome of tuberculosis under revised national tuberculosis control programme

Abstract

Background: Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis, is the major health care burden responsible for morbidity and mortality. The objective was to study the profile of adverse drug reactions (ADRs) and its outcome.Methods: It was a prospective observational study conducted in one of the RNTCP centre of Ahmedabad district. All TB patients visiting and taking short course of directly observed treatment (DOTS) were enrolled and monitored for ADRs. All the ADRs spontaneously reported or identified by the researcher were recorded and analyzed.Results: Total 974 patients screened during the study period 72 (7.79%) developed ADRs. Significantly higher occurrence of ADRs were in age group of 31- 40 years (p<0.01). Out of these 72 patients, 49 (68%) were having pulmonary TB. No statistically significant association was found between gender of patient, site of TB and occurrence of ADRs (p>0.05). Occurrence of ADRs was significantly more (p<0.05) in patients of category I TB (31, 43%). Out of the 49 (68%) pulmonary tuberculosis patients who developed ADR, 32 patients (44%) were sputum positive showing significant association (p<0.05). Gastro-intestinal side effects were most common ADRs followed by giddiness and headache. Nine patients required complete stoppage of offending agent, while 2 patients require treatment interruption and most of the patients (61) were managed with supportive medication without removing anti tubercular drug from their treatment regimen. Out of these 72 patients, majority (56) declared cured at the end of treatment.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

Assessment of Adverse Drug Reactions in Tuberculosis Patients of South India

“…Incidence of ADR was higher in females compared to males. In contrast to this, a study conducted by Dedun AR et al 19 showed that incidence of ADRs was more common in males. The reason for more occurrences of ADRs in females might be due to female's different life stages like pregnancy, menarche which modifies the drug response.…”

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

“…The overall prevalence of ADRs with FLDs is estimated to vary from 2.3 to 17% in various Indian studies. 7,[15][16][17] A study conducted by Mehrotra observed that the prevalence of ADRs in the initial intensive phase was 17.39%. 15 Another study conducted at a tertiary institute in Calcutta observed that the overall toxicity was found in 35% cases in the daily regimen group, whereas it was found to be 27.9% in the intermittent regimen group.…”

Adverse drug reactions associated with first line anti-tubercular drugs, their prevalence and causality assessment in patients on Directly Observed Treatment Short-course (DOTS) in a tertiary care hospital

“…15 Another survey in Malaysia reported an ADR incidence of 15.8%; while a study done in Gujarat, India reported an incidence of 7.9%. 19,20 One possible explanation of this variation could be differences in detecting methods of ADRs. As to whether ADRs were collected based on face to face interview with patients and chart review, or retrospectively from patient's medical records, besides genetic makeup could also have played a role.…”

“…23 Similar results have also been reported by Dedun et al, but there are some studies suggesting females to be at higher risk of developing more ADRs. 20,24 It might be because they pass through life stages like pregnancy, menarche and menopause that has an impact on the drug response. 25 Studies done by Aamir et al, and Hassan et al, also had found ADRs to occur more commonly in females than males.…”