PRAC agrees on communication to healthcare professionals about cases of liver injury with epilepsy medicine

Ontozry (cenobamate): new requirements for liver monitoring due to reports of severe liver injury

The EMA’s safety committee (PRAC) has reviewed new safety information on Ontozry, a medicine used to treat epilepsy. Cases of severe liver injury with hepatic failure, have been reported in some patients during treatment. It is recommended that liver function tests are performed prior to treatment initiation and during treatment, and that prompt clinical assessment is undertaken in case of symptoms suggestive of liver injury.

Patients should be advised to contact a doctor immediately if signs of liver injury occur. If liver injury is suspected or confirmed, a dose reduction or discontinuation of Ontozry should be considered in line with the SmPC, avoiding abrupt discontinuation unless required in order to minimize the risk of rebound seizures. 

Reporting suspected adverse reactions after authorization of the medicinal product is important for continue monitoring of the benefit/risk balance of the medicinal product.