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Codeine should not be prescribed for breastfeeding mothers or children under the age of 12

Moran Lazaryan1, Chen Shasha-Zigelman1, Zachi Dagan2

  • 1Pharmacy Department, Assaf Harofeh Medical Center, Zerifin, Sackler School of Medicine -Tel Aviv University, Tel-Aviv, Israel.

Acta Paediatrica (Oslo, Norway : 1992)
|March 27, 2015
PubMed

Insights

Codeine poses risks for children and breastfeeding mothers due to serious adverse events and uncertain effectiveness. Regulatory bodies now recommend against its use in these vulnerable populations.

Area of Science:

  • Pharmacology and Toxicology
  • Pediatric Medicine
  • Maternal Health

Background:

  • Regulatory authorities like the FDA and EMA have issued warnings concerning codeine use in pediatric patients and breastfeeding mothers.
  • Codeine's safety and efficacy in these specific populations have been questioned, prompting a review of existing data.

Purpose of the Study:

  • To explore the metabolic pathways and toxicological parameters of codeine in pediatric patients.
  • To investigate the implications of codeine use in breastfeeding mothers, focusing on infant exposure and effects.

Main Methods:

  • Systematic literature review of pharmacokinetic and pharmacodynamic studies.
  • Analysis of case reports and post-marketing surveillance data on codeine-related adverse events.
  • Evaluation of genetic polymorphisms affecting codeine metabolism.

Main Results:

  • Codeine metabolism varies significantly in children, leading to unpredictable plasma concentrations.
  • Serious adverse events, including respiratory depression, have been reported in pediatric populations.
  • Codeine transfer into breast milk can result in infant exposure, with potential for adverse effects.

Conclusions:

  • Given the risks of serious adverse events and questionable efficacy, codeine should not be prescribed for children under 12 years of age.
  • Codeine use is not recommended for breastfeeding mothers due to potential risks to the infant.
Abstract

Keywords:
BreastfeedingChildrenCodeineMorphinePaediatrics

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