Study of Suspected Adverse Drug Reactions of Selected Recently Introduced Medicines in Davangere City

Author(s)

Ravinandan, A.P., Varghese, A.R., Manasa, T., Raiby, S.B., Sushilkumar, P.L.

Author's Affiliation

Abstract

The present prospective study was focused to study the suspected adverse drug reactions of selected recently introduced medicines in Davangere city. Before commencement of the study, ethical committee clearance was obtained from Institutional Ethics Committee. A list of ten recently introduced medicines were selected on the basis of availability and frequency of dispensing, was done by referring the official website of CDSCO. The study was conducted at a tertiary care teaching hospital and randomly selected community pharmacies and obtained the informed consent from patients. After the index visit, the patients were followed and observed for the suspected adverse drug reactions. A total of 36 ADRs were reported from 27 patients. Seven ADRs were observed with Pregabalin (19.44%) followed by Torsamide 6(16.67%), Olmesartan 5(13.89%), Febuxostat 4(11.11%), Voglibose 4(11.11%), Doxofylline 3(8.33%), Moxonidine 3(8.33%), Ivabradine 2(5.56%), Ilaprazole 1(2.78%), Tadalafil 1(2.78%). The most commonly reported ADR was headache 7 (19.44%) and the most common organ system affected was CNS 18(50%). Most of the reactions were ‘Predictable’ 35(97.22%) and all ADRs were ‘Preventable’. Upon causality assessment of reported ADRs using WHO probability scale, majority of ADRs 22(61.11%) were rated as ‘Possible’. ADR reporting of recently introduced medicines gives more safety information’s about drugs both in-patient and out-patient departments, which enables the health care professionals to handle the medicines rationally.

Keywords

Adverse Drug Reactions, Recently Introduced Medicines, Health Care Professionals

Cite This Article

Ravinandan, A.P., Varghese, A.R., Manasa, T., Raiby, S.B., Sushilkumar, P.L. (2015). Study of Suspected Adverse Drug Reactions of Selected Recently Introduced Medicines in Davangere City, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(1), 242-250.