Toxic excipients in medications for neonates in Brazil.
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).


CONCLUSIONS
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.
Mother and Child Hospital of Brasilia, SGAS, Av. L2 Sul, Quadra 608, Módulo A Asa Sul, Brasília, Federal District, Brazil, alcidesiojr@gmail.com.
Alcidésio
A
Souza
Djanilson
D
Santos
Said
S
Fonseca
Marina
M
Medeiros
Lívia
L
Batista
Mark
M
Turner
Helena
H
Coelho
D001938:Brazil; D011307:Drug Prescriptions; D005079:Excipients / Q000633:toxicity*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D008297:Male; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012189:Retrospective Studies
D005079:Excipients; D004364:Pharmaceutical Preparations