Toxic Additives in Medications for Preterm Infants

Amy Whittaker ¹, Hussain Mulla ², Mark A Turner ³, Andrew E Currie ¹, David J Field ⁴ and Hitesh C Pandya ^5*

¹ Neonatal Unit, Leicester Royal Infirmary, University Hospitals Leicester NHS Trust, United Kingdom
² Centre for Therapeutic Evaluation of Drugs in Children, University Hospitals Leicester NHS Trust, United Kingdom
³ Division of Perinatal and Reproductive Medicine, University of Liverpool, United Kingdom
⁴ Department of Health Sciences, University of Leicester, United Kingdom
⁵ Department of Infection, Immunity & Inflammation, University of Leicester, United Kingdom

^* To whom correspondence should be addressed. E-mail: hp28{at}le.ac.uk.

Accepted 21 October 2008

Abstract

Background and objectives: Little is known about exposure of preterm infants to excipients during routine clinical care. The primary objective of this study was to document excipient exposure in vulnerable preterm babies in a single centre, taking into account chronic lung disease as a marker of illness severity.

Design: Excipient exposure following treatment with 8 oral liquid medications was determined by retrospectively analysing the drug charts of infants admitted to a neonatal unit.

Setting: The Leicester Neonatal Service.

Participants: 38 infants born between June 2005 and July 2006 who were less than 30 weeks and 1500g in weight at birth and managed in Leicester to discharge.

Results: The 38 infants represented 53% of the eligible target group; 7/38 infants had chronic lung disease (CLD). During their in-patient stay, infants were exposed to over 20 excipients including ethanol and propylene glycol - chemicals associated with neuro-toxicity. Infants with CLD were exposed to higher levels of these toxins. Infants were also exposed to high levels of sorbitol with some infants being exposed to levels in excess of recommended guidelines for maximum exposure in adults.

Conclusions: Excipient exposure is common in preterm infants including some potentially toxic excipients. Strategies aimed at reducing excipient load in preterm infants are urgently required.