Adverse Drug Reactions (ADR) necessitating modification of multi-drug therapy (MDT) in Hansen's disease: a retrospective study from Kerala, India

Objective: To assess the frequency and type of adverse drug reactions (ADR) that necessitated modification of multi-drug therapy (MDT) in Hansen's disease, with emphasis to find out the interval between initiation of MDT and the occurrence of ADR. Design: A retrospective analysis of case records of patients diagnosed with Hansen's disease (HD) and registered for MDT in a tertiary care institution between 2010 and 2015. Clinical details and laboratory data were collected using a proforma. Results: One hundred and ninety-six patients were registered for treatment during the study period. We analysed 150 records that met the inclusion criteria. Thirty-six among them (24%) had ADR that needed modification of MDT. The most common ADR was haemolytic anemia (19 patients; 12-7%) followed by hepatitis (14 patients; 9-3%). The most serious ADR was agranulocytosis (three patients; 2%). Adverse effects were more common (72%) during the initial 2 months of MDT compared to later months. (P = 0-004). Conclusion: Nearly a quarter of the patients started on MDT for Hansen's disease needed its stoppage and subsequent modification due to ADR. Haemolytic anemia and hepatitis were the most frequent adverse events. 72% of the ADR events occurred during the initial two months of MDT which points to the need for more frequent monitoring of the haemogram and liver function tests during the initial months of treatment.