Spanish health agency issues accidental paracetamol overdose warning for infant syrups after two serious incidents reported

The Spanish agency for medicines and health products (Aemps), which reports to the national Ministry of Health, has warned of the risk of accidental overdose of paracetamol in oral solution (syrups) for children, which can have serious consequences, including life-threatening liver toxicity.

This was reported by the agency on Tuesday, after the Spanish pharmacovigilance system (SEFV-H) received two cases of serious adverse reactions related to an accidental overdose in children. In both cases, the confusion was due to the fact that, in the patients' country of origin, these syrups contain a concentration of active substance three times lower than that available in Spain. Therefore, with the same volume, three times the dose was mistakenly administered.

According to Aemps, paracetamol is indicated for the symptomatic treatment of mild to moderate fever and pain. In Spain, paediatric formulations are sold in oral solution with a concentration of 100 milligrams per millilitre (mg/ml). To avoid possible errors, the organisation highlights the importance of adjusting the dose according to the concentration of the medicine and the patient's weight.

In the event of accidental administration of more than the recommended dose, the patient must receive medical attention, even if there are no obvious initial symptoms, as these may appear later, usually from the third day after administration. Signs and symptoms of paracetamol overdose include dizziness, vomiting, loss of appetite, jaundice, abdominal pain and kidney and liver failure.