Evaluation of dose and outcomes for pediatric vilazodone ingestions

Christopher E Gaw1,2, Henry A Spiller3,4, Jason L Russell3,4

  • 1a Center for Injury Research and Policy , Research Institute at Nationwide Children's Hospital , Columbus , OH , USA.

Insights

Pediatric vilazodone ingestions can cause severe effects, even at low doses. Prompt clinical evaluation is crucial for children under 6 exposed to vilazodone, and off-label use should be reconsidered.

Area of Science:

  • Pediatric Toxicology
  • Pharmacovigilance
  • Clinical Pharmacology

Background:

  • Selective serotonin reuptake inhibitors (SSRIs) are generally safe in young children.
  • Vilazodone, an SSRI, is increasingly used off-label and may cause more severe effects in children.
  • This study investigates vilazodone ingestion outcomes in children under 6.

Purpose of the Study:

  • To evaluate the dose-response relationship and clinical outcomes of vilazodone ingestions in children younger than 6 years.
  • To inform clinical management and safety guidelines for pediatric vilazodone exposure.

Main Methods:

  • Retrospective analysis of single-substance vilazodone exposures in children <6 years.
  • Data collected from the National Poison Data System (2011-2016).

Main Results:

  • 753 vilazodone ingestions reported; 49% experienced clinical effects.
  • Increased vilazodone dose correlated with higher rates of healthcare facility admission and serious outcomes.
  • Even low doses (10mg) caused severe effects like coma, seizures, and hallucinations.

Conclusions:

  • Vilazodone exposure poses a significant risk to children under 6.
  • Prompt medical evaluation is essential for exposed children.
  • Off-label use in this age group should be discouraged pending further safety research.
Abstract

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