Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database

Autor: Nariyasu Mano, Takamasa Sakai, Masami Tsuchiya, Yuriko Murai, Taku Obara, Gen Oyanagi, Makoto Miyazaki, Aoi Noda
Rok vydání: 2019
Předmět:
Drug
Adult
Male
Oseltamivir
Adolescent
Databases
Factual
Drug-Related Side Effects and Adverse Reactions
media_common.quotation_subject
Pharmacology toxicology
Pediatric patients
Adverse drug reaction
computer.software_genre
030226 pharmacology & pharmacy
03 medical and health sciences
chemistry.chemical_compound
Young Adult
Pharmacovigilance
0302 clinical medicine
Japan
lcsh:RA1190-1270
Medicine
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
030212 general & internal medicine
Child
Drug safety
Children
media_common
lcsh:Toxicology. Poisons
Pharmacology
Safety surveillance
The JADER
Database
business.industry
lcsh:RM1-950
medicine.disease
Unknown age
lcsh:Therapeutics. Pharmacology
chemistry
Adverse drug event
Female
Spontaneous reports
business
computer
Research Article
Signal detection
Zdroj: BMC Pharmacology & Toxicology
BMC Pharmacology and Toxicology, Vol 21, Iss 1, Pp 1-10 (2020)
ISSN: 2050-6511
Popis: Background There are no reports on investigations of the characteristics of adverse drug reaction (ADR) reports for pediatric patients in the Japanese Adverse Drug Event Report database (JADER) and the utility of database for drug safety surveillance in these patients. Method We aimed to evaluate ADR reports for pediatric patients in the JADER. We used spontaneous ADR reports included in the JADER since April 1, 2004, to December 31, 2017, which was downloaded in April 2018. In a total of 504,407 ADR reports, the number of spontaneous reports was 386,400 (76.6%), in which 37,534 (7.4%) were unknown age reports. After extraction of 27,800 ADR reports for children aged n = 6355) and no-suspected drug reports (n = 86). A total of 21,359 (4.2%) reports were finally included in this analysis. Results More than half of the ADR reports were for children aged oseltamivir, abnormal behavior, and oseltamivir and abnormal behavior, respectively. Conclusion We clarified the characteristics of ADR reports for Japanese children by using the JADER. ADR report databases, especially those for pediatric patients, are valuable pharmacovigilance tools in Japan and other countries. Therefore, a proper understanding of the characteristics of the ADR reports in the JADER is important. Additionally, potential signals for ADRs in pediatric patients should be monitored continuously and carefully.
Databáze: OpenAIRE
Externí odkaz: