An annual retrospective analysis of adverse drug reactions reported at adverse drug reaction monitoring center, Nalgonda

Background: Adverse drug reaction (ADR) monitoring is important for risk benefit analysis and for patient’s safety. ADR monitoring helps in maintaining the database which is specific to Indian population. Aims and Objectives: This study aims to analyze the pattern of ADRs, drug implicated, organ system affected, severity of ADRs, and their causality assessment. Materials and Methods: It was a retrospective analysis of all the ADRs reported to ADR monitoring center, Nalgonda, from January 2019 to December 2019. Prior ethics committee approval was obtained. ADRs were collected using suspected ADR forms provided by National Coordination Center-Pharmacovigilance Programme of India (NCC PVPI). All the ADRs were reported to NCC PVPI through VigiFlow software. Results: A total of 273 ADRs were reported of which 59% were female and 41% were male. According to the age group, 30–39 years were the most common age group affected about 26%. The most common drug class implicated for ADRs was antimicrobials. Skin was the most common system affected. Most of the ADRs belonged to probable category according to the WHO causality assessment scale. Only 9 (3%) ADRs were of serious nature. Conclusion: Pharmacovigilance is important for identification of ADRs due to drugs. Still, lot of awareness about pharmacovigilance needs to be created among health-care professionals to improve the reporting of ADRs. This, in turn, will improve the drug safety among patients

Thalidomide in lepra reaction (ENL) in lepromatous leprosy patients.

Six male bacteriologically highly positive patients of lepromatous leprosy with ENL reaction not adequately controlled by conventional antireaction drugs were put on thalidomide 400 mg per day in four divided doses. Reaction was controlled between 13th to 18th day of therapy. There was no change in the bacteriological status. Liver functions, renal functions and hemogram were normal before therapy and remained unaltered at the end of treatment. Apart from fatigue, drowsiness and occassional constipation, thalidomide had no adverse effect. Control of ENL reaction by thalidomide in these patients is probably due to its immunosuppressive effect, more likely by its stablising action on lysosomes.

Once monthly rifampicin (1200 mg) plus daily dapsone (100 mg) and clofazimine (100 mg) in the initial treatment of lepromatous leprosy.

The therapeutic effect of rifampicin 1200 mg once monthly and 100 mg clofazimine daily for the first six months of treatment was evaluated in 30 patients of bacteriologically positive lepromatous leprosy patients. Moderate to marked clinical improvement was seen in all the patients and a very rapid bacteriological regression as indicated by the decrease in bacteriological and morphological indices of the skin within one week. Seven patients become MI negative at one month and three months and 13 at the end of nine months. Two patients became MI and BI negative at the end of six months and six at the end of nine months. These observations clearly establish the high therapeutic efficacy and practicability of the three drug regimen. Once monthly rifampicin is highly effective and well tolerated, and has many advantages like low cost, better patient compliance and reliability of the treatment. Addition of clofazimine to rifampicin and dapsone prevents the emergence of E.N.L. reactions which were seen during treatment with once monthly rifampicin and daily dapsone. This regimen is thus ideal for initial, intensive treatment of lepromatous leprosy and may help in preventing the spread of the disease and development of dapsone resistance.