Toxic excipients in medications for neonates in Brazil

Abstract

The aim was to describe the exposure to excipients among neonates hospitalised in the neonatal intensive care unit (NICU) of a public hospital in Brasilia, Brazil. This was a retrospective study based on medicines that were prescribed electronically to neonates (≤28 days) who were admitted to the NICU of a hospital in Brasilia between January 1 and March 31, 2012. Excipients were identified from the medicine package leaflets and were classified according to toxicity. Seventy-nine infants received a total of 1,303 prescriptions comprising 77 formulations and 70 active drugs. Eighty-six excipients were identified, of which, 9 were harmful excipients (HE) and 48 were potentially harmful excipients (PHE). Almost all the neonates (98.7 %) were exposed to at least one HE and PHE. Preterm neonates (n = 64; 1,502 neonate days) presented high risk of exposure to polysorbate 80 (3.26/100 neonate days), sodium hydroxide (3.39), PG (3.19) and propylparaben (3.06). Full-term neonates (n = 15; 289 neonate days) presented risks in relation to phenol (4.84), ethanol (3.8) and sodium citrate (3.46).

Conclusion: Neonates in NICUs in Brazil are exposed to a wide variety of HE and PHE with unpredictable results. Safer alternatives are needed, as well as further studies on the subject.