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Arch Dis Child. 2016 Apr;101(4):371-6. doi: 10.1136/archdischild-2015-309396. Epub 2016 Jan 27.

Adverse drug reactions in neonates: a prospective study.

Author information

1
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.
2
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.
3
Nursery Department, Facultad de Enfermería Fisioterapia y Podología, Universidad Complutense de Madrid, Madrid, Spain.
4
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.
5
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.

Abstract

AIM:

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.

METHODOLOGY:

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.

KEYWORDS:

Adverse Drug Reactions; Drug-Related Side Effects; Neonatology; Newborns; Pharmacovigilance

[Indexed for MEDLINE]

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