Novartis Pharma GmbH, in agreement with the BfArM, has restricted the use of Tegretal Suspension (carbamazepine) in newborns up to 4 weeks of age. The active pharmaceutical ingredient is carbamazepine, and the suspension contains an excipient, propylene glycol, at a concentration exceeding recommended limits. This restriction is necessary due to the risk of serious adverse events in neonates, including metabolic acidosis, renal dysfunction, acute renal failure, and hepatic dysfunction.

Healthcare providers are instructed not to administer Tegretal Suspension to newborns. This communication serves as a critical update for medical professionals involved in pediatric care and pharmaceutical distribution. The restriction aims to mitigate potential harm to a vulnerable patient population. No specific compliance deadline is mentioned, but the restriction is effective immediately upon communication.