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Titolo:
Adverse drug reactions in children reported by means of the yellow card inSpain
Autore:
Morales-Olivas, FJ; Martinez-Mir, I; Ferrer, JM; Rubio, E; Palop, V;
Indirizzi:
Univ Valencia, Dept Farmacol, Valencia 46010, Spain Univ Valencia Valencia Spain 46010 Dept Farmacol, Valencia 46010, Spain Comunitat Valenciana, Ctr Farmacovigilancia, Valencia, Spain Comunitat Valenciana Valencia Spain Farmacovigilancia, Valencia, Spain Univ Valencia, Gen Hosp, Serv Invest, Valencia, Spain Univ Valencia Valencia Spain ia, Gen Hosp, Serv Invest, Valencia, Spain Univ Valencia, Gen Hosp, Unitat Farmacol Clin, Valencia, Spain Univ Valencia Valencia Spain osp, Unitat Farmacol Clin, Valencia, Spain
Titolo Testata:
JOURNAL OF CLINICAL EPIDEMIOLOGY
fascicolo: 10, volume: 53, anno: 2000,
pagine: 1076 - 1080
SICI:
0895-4356(200010)53:10<1076:ADRICR>2.0.ZU;2-0
Fonte:
ISI
Lingua:
ENG
Soggetto:
PEDIATRIC OUTPATIENTS; HOSPITAL ADMISSION;
Keywords:
adverse drug reactions; pharmacovigilance; pediatric patients; pharmacoepidemiology; spontaneous reporting;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
32
Recensione:
Indirizzi per estratti:
Indirizzo: Morales-Olivas, FJ Univ Valencia, Dept Farmacol, Avda Blasco Ibanez 15 & 17, Valencia 46010, Spain Univ Valencia Avda Blasco Ibanez 15 & 17 ValenciaSpain 46010
Citazione:
F.J. Morales-Olivas et al., "Adverse drug reactions in children reported by means of the yellow card inSpain", J CLIN EPID, 53(10), 2000, pp. 1076-1080

Abstract

Objective: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982-1991). Findings: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among malesthan in females. Less than 5% of the reports notified directly life-threatening or fatal reactions. Conclusions: Adverse drug reaction are not commonin pediatric patients, and most are mild. However, due to limitations of clinical trials in children, pharmacoepidemiological studies may be the onlysource of information on the benefit-risk profile of drugs received by these patients, and as such require special attention. (C) 2000 Elsevier Science Inc. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 18/01/20 alle ore 13:15:30