Greece’s National Organization for Medicines (EFET) has issued a warning to healthcare professionals regarding the use of a specific medicinal syrup in infants, following updated safety guidance agreed with pharmaceutical company Novartis Hellas. The alert concerns Tegretol (carbamazepine) Syrup 100 mg/5 ml and highlights the risks associated with its use in newborns.
According to the EOF, the syrup should not be administered to infants younger than four weeks old, or younger than 44 weeks of postmenstrual age in the case of premature babies. The restriction is linked to the product’s content of propylene glycol, an excipient that can accumulate in newborns due to immature metabolic and renal clearance systems.
Excessive exposure may lead to serious adverse effects, including metabolic acidosis, acute kidney failure, renal tubular damage, and liver dysfunction. Health authorities stress that use in newborns should only be considered when no alternative treatment is available and when the expected benefit clearly outweighs the potential risks. In such cases, close medical monitoring is required.
The updated guidance applies exclusively to this syrup formulation, while other forms of the same medication remain unaffected. Healthcare professionals are urged to report any suspected adverse reactions through the national pharmacovigilance system.
