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Toxic excipients in medications for neonates in Brazil

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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.

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Acknowledgement

This study was supported by grants from the Institute of Health Science—Research and Teaching Foundation—FEPECS.

Conflict of interest

The authors declare that they have no personal financial relationship with the sponsoring organisations or any other potential conflicts of interest.

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Authors and Affiliations

  1. Mother and Child Hospital of Brasilia, SGAS, Av. L2 Sul, Quadra 608, Módulo A Asa Sul, Brasília, Federal District, Brazil

    Alcidésio Souza Jr

  2. Doctoral Program on Development and Technological Innovation in Drugs, Federal University of Ceará, Fortaleza, Ceará, Brazil

    Alcidésio Souza Jr, Said Fonseca & Helena Coelho

  3. Postgraduate Programme on Pharmaceutical Sciences, Federal University of Ceará, Fortaleza, Ceará, Brazil

    Djanilson Santos, Marina Medeiros, Lívia Batista & Helena Coelho

  4. Federal University of Recôncavo da Bahia, Santo Antônio de Jesus, Bahia, Brazil

    Djanilson Santos

  5. Department of Women’s and Children’s Health, University of Liverpool, Liverpool, UK

    Mark Turner

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  1. Alcidésio Souza Jr
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  2. Djanilson Santos
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Correspondence to Alcidésio Souza Jr.

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Communicated by Patrick Van Reempts

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Souza, A., Santos, D., Fonseca, S. et al. Toxic excipients in medications for neonates in Brazil. Eur J Pediatr 173, 935–945 (2014). https://doi.org/10.1007/s00431-014-2272-z

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  • DOI: https://doi.org/10.1007/s00431-014-2272-z

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