ArticleEuropean journal of pediatrics2014
Toxic excipients in medications for neonates in Brazil.
Article in European journal of pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02545712 (Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Parabens, Acesulfam k, Aspartame, Glycerol, Sorbitol and Polysorbate-80 Exposed to Pediatric Patients), which is not on this map. Cited by 15 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safe Excipient Exposure in Neonates and Small ChildreN - a Retrospective, Descriptive Study Off the Amount of Ethanol, Propylene Glycol, Benzyl Alcohol, Parabens, Acesulfam k, Aspartame, Glycerol, Sorbitol and Polysorbate-80 Exposed to Pediatric Patients
Who cites it
15 citing papers in PubMed.
- Optimising Formulations for Paediatric Patients with Inherited Metabolic Disorders: The Case Study of Levocarnitine.Pharmaceutical medicine · 2026Review
- Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study.Pharmacy (Basel, Switzerland) · 2024Article
- Quantitative Investigation on Exposure to Potentially Harmful Excipients by Injection Drug Administration in Children Under 2 Years of Age and Analysis of Association with Adverse Events: A Single-Center, Retrospective Observational Study.Therapeutic innovation & regulatory science · 2024Observational
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Compounded medications for cardiovascular use in neonatology: an integrative review.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2022Review
- Potentially harmful excipients in neonatal medications: a multicenter nationwide observational study in Japan.Journal of pharmaceutical health care and sciences · 2021Article
- Pediatric Safety of Polysorbates in Drug Formulations.Children (Basel, Switzerland) · 2019Article
- Hypersensitivity reactions to food and drug additives: problem or myth?Acta bio-medica : Atenei Parmensis · 2019Review
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Excipient exposure in very low birth weight preterm neonates.Journal of perinatology : official journal of the California Perinatal Association · 2018Article
- Product Substitution as a Way Forward in Avoiding Potentially Harmful Excipients in Neonates.Paediatric drugs · 2016Article
- Harmful excipients in medicines for neonates in Spain.International journal of clinical pharmacy · 2016Article
- Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study.BMC pediatrics · 2016Article
- Pharmacokinetics in neonatal prescribing: evidence base, paradigms and the future.British journal of clinical pharmacology · 2015Review
- An observational study of blood concentrations and kinetics of methyl- and propyl-parabens in neonates.Pharmaceutical research · 2015Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledThe 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).
conclusionNeonates 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.