Analysis Of Adverse Drug Reactions In Children

Abstract

S U N D A Y 374 Analysis Of Adverse Drug Reactions In Children G. M. Park, J. H. Seo, H. Y. Kim, Y. W. Hwang, Y. S. Na, Y. C. Song, J. H. Yu, S. J. Hong; Childhood Asthma Atopy Center, Department of Pediatrics, Department of Pharmacy, Asan Medical Center, University of Ulsan College of Medicine, seoul, REPUBLIC OF KOREA, Childhood Asthma Atopy Center, Research Center for Standardization of Allergic Diseases, Department of Pediatrics, Asan Medical Center, University of Ulsan College of Medicine, seoul, REPUBLIC OF KOREA, Department of Pharmacy, Asan Medical Center, University of Ulsan College of Medicine, seoul, REPUBLIC OF KOREA, Childhood Asthma Atopy Center, Department of Pediatrics, Asan Medical Center, University of Ulsan College of Medicine, seoul, REPUBLIC OF KOREA. RATIONALE: The incidence of adverse drug reactions(ADRs) is increasing. However, the studies about the prevalence of ADRs in children are rare compared to reports in adult. In order to investigate the causative drugs and clinical features of ADRs in children, we performed a study in a tertiary university hospital of Korea. METHOD: We prospectively collected ADR data by a computerized spontaneous reporting system at our university hospital. ADR data of children under the age 18 collected from January 2005 to May 2011 were analyzed. RESULTS: 1924 ADR cases were reported in 1086 male(56%) and 838 female(44%), and mean age was 9.365.9 years(0-18 years). Antibiotics(n5769, 45%) were the most common causative drugs, followed by analgesics(n5144, 9%) such as tramadol and opiate, non-steroidal antiinflammatory agents(NSAIDs) and acetylsalicylic acid(n5124, 7%), radiocontrast media(n577, 5%) and sedatives(n570, 4%). The most common clinical features were skin manifestations(n5961, 52%) such as urticaria, pruritus, skin rash and angioedema.Gastrointestinal symptoms(n5402, 22%) were the second clinical features, followed by respiratory symptoms(n5157, 9%) including mainly dyspnea. Among antibiotics, penicillin/s-lactamase inhibitors(n580, 16%), third-generation cephalosporins(n578, 15%) and glycopeptides(n566, 13%) were the most frequently reported causative drugs. CONCLUSION: Antibiotics were reported most common causative drug of ADRs in children and the clinical features were mainly skin reactions. Close monitoring system may be useful to detect ADRs early in children.