Overview
- The Spanish Pharmacovigilance System, coordinated by AEMPS, confirmed two serious adverse reactions in children following accidental overdoses of paracetamol oral solution.
- Investigators found that caregivers gave the same volume they used abroad, where pediatric syrups were about one third the strength of Spain’s 100 mg/ml products, resulting in triple the intended dose.
- AEMPS urges immediate medical evaluation after any suspected excess dose, warning that symptoms such as vomiting, jaundice, abdominal pain and liver injury can emerge around the third day.
- Prescribers are advised to specify doses in exact millilitres based on the product’s concentration and the child’s weight and to confirm that parents understand the volume and dosing frequency.
- Parents should use the supplied measuring syringe or dropper and consult pharmacists if unsure, and clinicians should take extra care with families used to foreign formulations, with no product recalls announced.