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Abstract

ADVERSE DRUG REACTIONS ATTRIBUTED TO THE USE OF ANTICOAGULANTS IN PATIENTS WITH CARDIAC AND VASCULAR DISORDERS IN A TERTIARY CARE TEACHING HOSPITAL

Hebah Fatima*, Zoha Nazneen, Syeda Sara Sultana, Sarah Tabassum and Mohd. Mohiuddin Shareef

Abstract

Background: Anticoagulants are commonly prescribed drugs for cardiac and vascular disorders. They are high potency medications with an equally high potential to induce adverse drug reactions. Objective: To observe the prevalence of adverse drug reactions in patients on anticoagulant therapy, to assess their occurrence, severity, management, and possible prevention. Materials and Methods: This prospective observational study was carried out on a total of 120 patients, in a tertiary care teaching hospital. Assessment of adverse drug reactions was done using WHO-UMC criteria and Naranjo causality scale, Hartwig and Siegel severity scale, and Schumock and Thornton preventability criteria. Results: Out of 120 patients, 18 showed the occurrence of adverse drug reactions, the majority of which were attributed to Unfractionated Heparin (50%). A strong positive significant correlation was seen between age and the occurrence of adverse drug reactions. Epistaxis was the most common adverse drug reaction reported. International Normalized Ratio was evaluated for 11 out of 18 patients. Adverse drug reactions due to drug-drug interactions were observed in 7 patients. The WHO-UMC criteria and Naranjo scale revealed that all of the adverse drug reactions were certain and probable and were probably preventable based on Schumock and Thornton criteria. Two of the adverse drug reactions were severe as per the assessment by the modified Hartwig and Siegel severity scale. About 50% (n=9) of the reactions were of Type-A according to Wills and Brown's classification. Conclusion: Our study emphasizes the need for monitoring anticoagulant therapy to prevent the incidence of adverse drug reactions and associated complications, and also the need to enquire about and report adverse drug reactions, particularly when drugs with significant potential to cause them are administered.

Keywords: Anticoagulants, Cardiovascular disease, Adverse drug reactions, Causality assessment, Pharmacovigilance.


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