SAFETY REPORTING STUDY OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS

Background: The nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently used drugs to treat pain and inflammation. Although NSAIDs are having enormous clinical use, but are not devoid of adverse drug reactions (ADRs) as peptic ulcer, gastritis, renal, neurological reactions etc. Methods: Total 500 Orthopaedic out-patients of SIMS, Hapur were enrolled in the study to observe the risk of ADRs due to NSAIDs. All the ADRs were further analysed in relation to age, sex, types of drug and its pattern etc. The causality was analysed by using Naranjo’s Algorithm and severity was analysed by using the Hartwing and Siegel scale. Results: In this study the incidence rate of the ADRs was around 5.6%. Among the 28 patients who had developed ADRs, a total 10 kinds of ADRs were observed. The reactions that affected the study subjects were gastritis, nausea, vomiting, abdominal Pain, diarrhoea, urticaria, pruritus, headache, rash, ankle oedema and dizziness. Majority (23 cases) of ADRs were mild in their severity and that 5 cases ADRs were moderate in nature. All the ADRs were treated symptomatically by using standard treatment protocols. Conclusion: In this study, incidence of adverse reactions to nonsteroidal anti-inflammatory drugs was 5.60% and the most common implicated drug for the ADRs were Diclofenac sodium. Most of the adverse effects were mild and tolerable. Keywords: Adverse drug reactions, Nonsteroidal anti-inflammatory drugs, Pharmacovigilance