A PHARMACOVIGILANCE STUDY IN THE DEPARTMENT OF CHEST & TUBERCULOSIS ON ANTI TUBERCULAR THERAPY IN A TERTIARY CARE TEACHING HOSPITAL OF SOUTH INDIA

Tuberculosis has been one of the common diseases in human communities during the past 40 years. It has been reported by World Health Organization (WHO) that one third of the world’s population is infected with Mycobacterium tuberculosis resulting in 8.4 million new tuberculosis cases in 1999, this high incidence of infection has caused a large number of morbidity and mortality which is partly due to serious adverse reactions induced by Anti-TB drugs. The current prospective observational study of six months duration was designed to assess the rate of adverse drug reactions (ADRs) induced by anti tubercular drugs in patients admitted in the department of Chest & Tuberculosis from whom a proper consent obtained. The results of the study showed that the incidence of all major adverse effects was 1.48 per 100 person’s month of exposure. The occurrence of any major side effect in the study was associated with female sex and increase in age. In our study the major cause of admission was adverse drug reactions in 15.9% of patients. In our study Hepatitis was observed in 25 (25.77%) patients, leading to the death of 2 patients. In conclusion, Anti-TB drugs could cause significant adverse effects both in quantity and severity. These reactions may lead to hospitalization, prolonged hospital stay and even death. These results suggest that the protocol may need some revision to prevent fatalities. To confirm this hypothesis many more studies with large population is needed.