Abstract

Drug-induced liver injury is a rare but life-threatening phenomenon. Paracetamol is referred to as a drug with a direct dose-dependent hepatotoxic eff ect. Th e use paracetamol, even in therapeutic doses, is essentially safe, but requires a sensible approach while prescribing it to the risk groups and “off - label”. Th e use of paracetamol in children is limited at the age of less than 3 months. Signifi cant damage to hepatocytes by paracetamol in children is relatively rare and only occurs in 10% of the cases while taking potentially toxic doses of the drug. We have recorded a clinical case of toxic hepatitis development in a newborn aft er intravenous “off -label” administration of therapeutic doses of paracetamol in order to relieve the pain syndrome. Th is case is indicative of the fact that even therapeutic doses of paracetamol, as well as the predominantly sulfate pathway of drug biotransformation, which is typical for children under 14 years of age, does not rule out the possibility of toxic drug-induced liver damage. Taking into account the described case, there is a need to determine clear indications for “off -label” use of the drug in view of the possible toxic eff ect development.

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