Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct-Dec;13(4):194-198.
doi: 10.4103/picr.PICR_279_20. Epub 2021 Jul 12.

Adverse drug reaction profile of daily regimen antituberculosis treatment

K N Hari Sankar  1 , Kevin Roch  1 , Doyce Jom  2 , Dhanya S Palappallil  1 , Prabitha Panattil  1 , Rajani K Sankaranarayanan  3
Affiliations

Adverse drug reaction profile of daily regimen antituberculosis treatment

K N Hari Sankar et al. Perspect Clin Res. 2022 Oct-Dec.

Abstract

Objectives: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern.

Materials and methods: This was a descriptive study conducted in the Department of Pharmacology of a Government Medical College in Central Kerala and the period under study was October 2017-June 2020. The data on ADR were entered into a structured pro forma and data were analyzed using SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA).

Results: Of the 643 ADRs, 98 (15.24%) were suspected to be due to the daily regimen of ATT. The most common organ system affected was hepatobiliary 46 (46.9%) namely hepatitis in 35 and asymptomatic elevated liver enzymes in 11 followed by eye with 26 reports of decreased vision. In 96 (97.95%), the suspected ADR had probable causality and in 2 (2.04%) it was possible. Seventy-seven (78.6%) ADR reports were serious as well as moderate-level 4b in severity and 57 (58.16%) were probably preventable. The mean days of onset of ADR after starting the ATT regimen were 56.40 ± 58.29 days (range 1-180). Decrease in vision with a mean duration of 125.23 ± 55.46 days had the longest latency in onset among all the ADRs.

Conclusions: Of all the ADRs reported to AMC 15.24% were due to the daily regimen of ATT. Hepatitis was the most common ADR encountered followed by decrease in vision. The majority of the ADRs were probable in causality, serious, moderate-level 4b in severity, and probably preventable.

Keywords: Adverse drug reaction; antituberculosis treatment; daily regimen.

PubMed Disclaimer

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Treatment of adverse drug reaction
Figure 2
Figure 2
Temporal relation of adverse drug reaction
See this image and copyright information in PMC

References

    1. World Health Organisation. Tuberculosis. [Last accessed on 2020 Jul 13]. Available from: https://www.who.int/health-topics/tuberculosis#tab=tab_1.
    1. Gholami K, Kamali E, Hajiabdolbaghi M, Shalviri G. Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients. Pharm Pract (Granada) 2006;4:134–8. - PMC - PubMed
    1. Kurniawati F, Sulaiman SA, Gillani SW. Adverse drug reactions of primary anti-tuberculosis drugs among tuberculosis patients treated in chest clinic. Int J Pharm Life Sci. 2012;3:13312–8.
    1. India TB Report. 2018. [Last accessed on 2020 Jun 05]. Available from: https://tbcindia.gov.in/showfile.php?lid=3314 .
    1. Technical and Operational Guidelines for Tuberculosis Control in India. 2016. [Last accessed on 2020 Jun 05]. Available from: https://tbcindia.gov.in/index1.php?lang=1&level=2&sublinkid=4573&919lid=... .