title: Adverse drug reactions in neonates: a prospective study.
abstract: OBJECTIVE
  To investigate the frequency and characteristics of adverse drug reactions (ADRs) in hospitalised neonates to obtain a better understanding of and improvement in neonatal healthcare.
  
  
  METHODS
  A prospective cohort study. Data were collected on 313 neonates and 2166 drug prescriptions. Clinical characteristics of patients, drugs administered and ADRs were prospectively recorded and analysed. Informed consent was obtained in all cases.
  
  
  RESULTS
  116 different ADRs were detected. 17% of the neonates experienced at least one of these ADRs. Systemic antimicrobials and caffeine citrate were the drugs that most commonly caused ADRs. According to the ADR Severity Assessment Scale, 41% were mild, 42% were moderate and 17% were severe. Of the ADRs identified, 11% were classified as 'certain' by the Naranjo method and 20% were classified as 'defined' by the Karch and Lasagna modified algorithm. Most of the ADRs detected were related to feed intolerance, phlebitis and tachycardia. Most were acute (73%) and lasted between 1 and 7 days (39%). After the occurrence of an ADR, it was necessary to initiate specific treatment in 44 cases, discontinue the drugs involved in 30 cases, and reduce the drug dose in another 30 cases. An association was shown between the number of drugs prescribed and ADR onset.
  
  
  CONCLUSIONS
  There is a high incidence of ADRs in hospitalised newborns, which increases with the number of prescriptions.
authors.affiliation: Nursery Department, UICEC, Hospital Clínico San Carlos, Facultad de Enfermería Fisioterapia y Podología, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Belén Rivas
authors.affiliation: Neonatology Department, Hospital Clínico San Carlos, Madrid, Spain Departamento de Pediatría, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Arruza
authors.affiliation: Nursery Department, Facultad de Enfermería Fisioterapia y Podología, Universidad Complutense de Madrid, Madrid, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Pacheco
authors.affiliation: Departamento de Pediatría, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain Clinical Pharmacology Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Portoles
authors.affiliation: Nursery Department, Facultad de Enfermería Fisioterapia y Podología, Universidad Complutense de Madrid, Madrid, Spain.
authors.forename: Jorge
authors.initials: J
authors.lastname: Diz
authors.affiliation: Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain Departamento de Pediatría, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
authors.forename: Emilio
authors.initials: E
authors.lastname: Vargas
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D008297:Male; D011446:Prospective Studies
keywords: Adverse Drug Reactions; Drug-Related Side Effects; Neonatology; Newborns; Pharmacovigilance