Potentially harmful excipients in neonatal medicines: A pan-European observational study

Georgi Nellis, Tuuli Metsvaht, Tuuli Metsvaht, Heili Varendi, Karolin Toompere, Jana Lass, Inge Mesek, Anthony J. Nunn, Mark A. Turner, Irja Lutsar, Susan Graham, Jennifer Duncan, Utpal Shah, Hussain Mulla, Hitesh Pandya, James McElnay, Jeff Millership, Shirish Yakkundi, Andre Rieutord, Thomas StormePascal Vaconsin, Bernhard Resch, Pieter De Cock, Nelly Jekova, Elisabeth Iyore, Kosmas Sarafidis, Aranka Vegso, Noreen O'Callaghan, Rocco Agostino, Daiga Kviluna, Rasa Tameliene, Rene F. Kornelisse, Dag Bratlid, Almerinda Pereira, Maria Livia Ognean, Milica Bajcetic, Darja Paro, Elizabeth Valls, Per Nydert, Hans Ulrich Bucher, Maria Cordina

Research output: Contribution to journalArticlepeer-review

38 Citations (Scopus)


Objectives We aimed to describe administration of eight potentially harmful excipients of interest (EOI)-parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride-to hospitalised neonates in Europe and to identify risk factors for exposure. Methods All medicines administered to neonates during 1 day with individual prescription and demographic data were registered in a web-based point prevalence study. Excipients were identified from the Summaries of Product Characteristics. Determinants of EOI administration (geographical region, gestational age (GA), active pharmaceutical ingredient, unit level and hospital teaching status) were identified using multivariable logistical regression analysis. Results Overall 89 neonatal units from 21 countries participated. Altogether 2095 prescriptions for 530 products administered to 726 neonates were recorded. EOI were found in 638 (31%) prescriptions and were administered to 456 (63%) neonates through a relatively small number of products (n=142; 27%). Parabens, found in 71 (13%) products administered to 313 (43%) neonates, were used most frequently. EOI administration varied by geographical region, GA and route of administration. Geographical region remained a significant determinant of the use of parabens, polysorbate 80, propylene glycol and saccharin sodium after adjustment for the potential covariates including anatomical therapeutic chemical class of the active ingredient. Conclusions European neonates receive a number of potentially harmful pharmaceutical excipients. Regional differences in EOI administration suggest that EOI-free products are available and provide the potential for substitution to avoid side effects of some excipients.
Original languageEnglish
Pages (from-to)694-699
Number of pages6
JournalArchives of Disease in Childhood
Issue number7
Early online date08 Apr 2015
Publication statusPublished - 2015

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