Allergy Asthma Respir Dis.  2016 Sep;4(5):354-359. 10.4168/aard.2016.4.5.354.

Pediatric adverse drug reactions collected by an electronic reporting system in a single tertiary university hospital

Affiliations
  • 1Department of Pharmacy, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 2Department of Pediatrics, Childhood Asthma Atopy Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. sjhong@amc.seoul.kr
  • 3Environmental Health Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 4Allergy and Clinical Immunology, Asan Regional Pharmacovigilance Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Abstract

PURPOSE
The incidence of adverse drug reactions (ADRs) is increasing. However, studies on the prevalence of ADRs in children are rare. The aim of this study was to investigate the causative drugs and clinical features of ADRs for children in a tertiary university hospital of Korea.
METHODS
We retrospectively collected ADRs by a computerized self-reporting system in Asan Medical Center. ADRs of children under the age 18 were collected from January 2005 to August 2015, and we analyzed only ADRs containing current symptoms among total ADR data.
RESULTS
A total of 1,408 ADR cases were reported, There were 764 male (54.3%) and 644 female patients (45.7%), and the mean age was 11.5±5.8 years (range, 0-18 years). Antibiotics (n=479, 34.0%) were the most common causative drugs, followed by tramadol (n=173, 12.3%), nonsteroidal anti-inflammatory agents (NSAIDs) and acetylsalicylic acid (n=103, 7.3%), narcotics (n=91, 6.5%), antineoplastics (n=87, 6.2%), and sedatives (n=82, 5.8%). The most common clinical features were skin manifestations (n=500, 34.4%). Gastrointestinal symptoms (n=435, 29.9%) were the second most common clinical features, followed by neuropsychiatric symptoms (n=155, 10.7%) and respiratory symptoms (n=123, 8.5%). Among antibiotics, glycopeptides (n=110, 23.0%), third-generation cephalosporins (n=83, 17.3%), and penicillin/β-lactamase inhibitors (n=60, 12.7%) were the most frequently reported causative drugs.
CONCLUSION
Antibiotics were the most reported common causative drugs of ADRs in children, followed by tramadol, NSAID, and narcortics. Compared with adults, the prevalence of contrast medium-induced ADR was lower in children with a higher prevalence of sedative-associated ADR. Greater attention to possible ADRs in children is needed among medical personnel.

Keyword

Adverse drug reaction; Child; Antibiotics; Tramadol; Sedatives

MeSH Terms

Adult
Anti-Bacterial Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Aspirin
Cephalosporins
Child
Chungcheongnam-do
Drug-Related Side Effects and Adverse Reactions*
Female
Glycopeptides
Humans
Hypnotics and Sedatives
Incidence
Korea
Male
Narcotics
Prevalence
Retrospective Studies
Skin Manifestations
Tramadol
Anti-Bacterial Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Aspirin
Cephalosporins
Glycopeptides
Hypnotics and Sedatives
Narcotics
Tramadol

Figure

  • Fig. 1 Frequencies of antibiotics that caused adverse drug reactions.


Cited by  2 articles

Clinical implication of adverse drug reaction surveillance in children
Eun Hee Chung
Allergy Asthma Respir Dis. 2016;4(5):309-310.    doi: 10.4168/aard.2016.4.5.309.

Analysis of pediatric adverse drug reactions reported to regional pharmacovigilance center of a single university hospital
Do-Woo Kim, Yun-Chang Choi, Young-Seok Lee, Young-Hee Nam, Jin-A Jung
Allergy Asthma Respir Dis. 2018;6(5):263-269.    doi: 10.4168/aard.2018.6.5.263.


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