Abstract
Dafalgan Pédiatrique/Dafalgan Kind recently adapted its syrup. This new formulation contains propylene glycol as excipient, as mentioned in the product information in accordance with the European Commission guideline (> 1 mg/kg/day in neonates). The guideline’s thresholds relate to the specific information that should appear in the package leaflet, not similar to safety thresholds. There is a 28-fold difference in propylene glycol exposure between both currently marketed products (Dafalgan versus Perdolan, 7 versus 293.5 mg/kg/day), so that there is an opportunity to limit exposure below clinical relevance, without full avoidance. The current knowledge on propylene glycol in children is summarized.