Risk assessment of neonatal excipient exposure: lessons from food safety and other areas.
Newborn babies can require significant amounts of medication containing excipients intended to improve the drug formulation. Most medicines given to neonates have been developed for adults or older children and contain excipients thought to be safe in these age groups. Many excipients have been used widely in neonates without obvious adverse effects. Some excipients may be toxic in high amounts in which case they need careful risk assessment. Alternatively, it is conceivable that ill-founded fears about excipients mean that potentially useful medicines are not made available to newborn babies. Choices about excipient exposure can occur at several stages throughout the lifecycle of a medicine, from product development through to clinical use. Making these choices requires a scalable approach to analysing the overall risk. In this contribution we examine these issues.
University of Liverpool, Department of Women's and Children's Health, Institute of Translational Medicine, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool L8 7SS, UK. Electronic address: mark.turner@liverpool.ac.uk.
M A
MA
Turner
Research and Development, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool L12 2AP, UK.
J C
JC
Duncan
Research and Development, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool L12 2AP, UK.
U
U
Shah
Tartu University Clinics, Department of Anesthesiology and Intensive Care, Lunini 6, 51014 Tartu, Estonia.
T
T
Metsvaht
Tartu University Clinics, Children's Hospital, Lunini 6, 51014 Tartu, Estonia.
H
H
Varendi
Tartu University Clinics, Children's Hospital, Lunini 6, 51014 Tartu, Estonia.
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G
Nellis
University of Tartu, Department of Medical Microbiology, Ravila Str 19, 50411 Tartu, Estonia.
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I
Lutsar
Clinical & Practice Research Group, School of Pharmacy, Queen's University Belfast, Northern Ireland, UK.
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S
Yakkundi
Clinical & Practice Research Group, School of Pharmacy, Queen's University Belfast, Northern Ireland, UK.
J C
JC
McElnay
Department of Infection Immunity and Inflammation, University of Leicester, UK.
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H
Pandya
University Hospitals of Leicester, Department of Pharmacy, UK.
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H
Mulla
APHP-Hospital Robert Debré, Pharmacy Department, Paris, France.
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P
Vaconsin
APHP-Hospital Robert Debré, Pharmacy Department, Paris, France.
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T
Storme
APHP-Hospital Antoine Beclère, Pharmacy Department, Clamart, France.
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A
Rieutord
Research and Development, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool L12 2AP, UK.
A J
AJ
Nunn
D000818:Animals; D005079:Excipients / Q000009:adverse effects*; D059022:Food Safety; D006801:Humans; D007231:Infant, Newborn; D018570:Risk Assessment
D005079:Excipients
Adverse effects; Excipients; Medicines; Neonates; Paediatrics; Pharmaceutical development; Risk analysis; Risk management