Background: The nonsteroidal anti-inflammatory drugs
(NSAIDs) are among the most frequently used drugs to treat pain and
inflammation. NSAIDs constitute the largest single group of drugs used
worldwide, constituting more than 20% of all drug prescriptions. Although
NSAIDs have enormous clinical use, but are not devoid of adverse drug reactions
(ADRs) such as peptic ulcer, gastritis, renal, neurological reactions, etc.
Therefore, this pilot study is intended to assess the incidence and pattern of
ADRs of NSAIDs in a tertiary care teaching hospital.
Methods: This is a prospective observational study, which
was executed in the department of Orthopaedics with association of the
department of Pharmacology, SIMS Medical College, Hapur, UP, India. A total of
600 Orthopaedic outpatients 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: Out of the 600 patients with NSAID therapy, 35
patients (5.83%) experienced a total of 10 types of ADRs. The adverse drug
reactions observed by the patients were gastric symptoms, headache, urticaria,
oedema etc. The most frequently observed ADR was gastritis. Out of 35 patients
who had ADRs, 62.86% were male and 37.14% were female. The study found that
Gender and age did not show any statistical significance in relation to the
occurrence of adverse drug reactions due to prescribed NSAIDs. Among all the
prescribed drugs, Tab Diclofenac sodium accounted for 57.14% and Paracetamol
for 11.42% of all the ADRs. According to Naranjo’s Algorithm, 62.87% of ADRs
were possible’ and 37.14% were of probable type and ADRs were mostly mild in
severity.
Conclusion: In this study, the incidence of adverse
reactions to nonsteroidal anti-inflammatory drugs was 5.83 and the most
commonly implicated drug for the ADRs was Diclofenac sodium. Most of the
adverse effects were mild and tolerable.
Author(s) Details
Saborni Dey
Department of Pharmacology, Saraswathi Institute of Medical Sciences,
Hapur, Uttar Pradesh, India.
Harsh Kumar
Department of Orthopedics, Saraswathi Institute of Medical Sciences, Hapur,
Uttar Pradesh, India.
Anand Kumar Shukla
Department of Pharmacology, Saraswathi Institute of Medical Sciences,
Hapur, Uttar Pradesh, India
Please see the book here:- https://doi.org/10.9734/bpi/prrat/v4/1120
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