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Characteristics of Cardiovascular Adverse Drug Reactions Reported to KFDA  

Rhew, Ki-Yon (College of Pharmacy, Dongduk Women's University)
Cho, Hea-Kyoung (Regulatory Affairs, Bristol-Myers Squibb Company)
Lee, Suk-Hyang (College of Pharmacy, Ajou University)
Publication Information
Korean Journal of Clinical Pharmacy / v.22, no.1, 2012 , pp. 41-46 More about this Journal
Abstract
Adverse drug reaction (ADR) is a global problem of major concern in health care. ADRs can be accrued in any organs or systems. However, cardiovascular ADRs could be a more serious problem if they are irreversible or severe. For this reason, this study was conducted to analyze pattern and severity of cardiovascular ADRs, and suspicious medication. Total 646 reports including cardiovascular ADRs reported to the KFDA between January and June 2010 were analyzed. Amlodipine besylate (36 reports, 3.3%), iopromide (29 reports, 2.7%), tramadol HCl (28 reports, 2.6%) were most suspicious drugs that occurred cardiovascular ADRs. The most common cardiovascular ADRs were hypotension( 236 reports, 33.1%), palpitation (134 reports, 18.8%), and hypertension (89 reports, 12.5%). The most frequent ADRs were occurred in the age group of more than 60. This result could be of help to prescribers and other healthcare providers to predict and prevent cardiovascular ADRs. Also this study suggested that patients with cardiovascular ADR risk factors should be intensively monitored during the medications.
Keywords
adverse drug reaction; cardiovascular ADRs; ADR reporting system; pharmacovigilance;
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Times Cited By KSCI : 2  (Citation Analysis)
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