Goel A, Saxena R, Kalaiselvan V, Goyal RK, Mohan A, Mathur R
Delhi Pharmaceutical Sciences and Research University
All India Institute of Medical Sciences, New Delhi, INDIA
Abstract
Tuberculosis (TB) is one of the world's most important illnesses, it contributes around 2.5% to the global burden of diseases. India reported 25 lakhs TB patients in 2020 with the estimated incidence of 188 in 10,000 people. Ethambutol, an antimycobacterial drug, is used as the first-line drug in combination with isoniazid, rifampicin, pyrazinamide. It works by obstructing the formation of cell wall. In 2016, the Revised National Tuberculosis Control Programme (RNTCP) was updated and the Ethambutol treatment was expanded from 2 to 6 months along with the change in thrice a week regimen to daily dose regimen. The prolonged exposure to ethambutol unless well managed could increase the incidence of optic neuropathy resulting in substantial visual impairment. In order to address this paucity in data, an observational pharmacovigilance study has been planned in collaboration with AIIMS, New Delhi and IPC, Gaziabad. The study includes Tuberculosis patients who have been treated with Ethambutol for more than 2 months and been enrolled in the DOTS Centre, AIIMS. The patients complaining of the visual inefficacy were referred to the Dr. Rajendra Prasad Ophthalmic Centre, AIIMS for Visual Acuity Testing and Colour Vision testing. Further Ocular Coherence Tomography (OCT) and Ocular Fundus Examination will be performed of patient having colour vision deterioration. Optic neuropathy, decreased visual acuity AND abnormal colour vision may be associated with Ethambutol.