New safety information for healthcare professionals 

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

PRAC agreed on a direct healthcare professional communication (DHPC) to inform healthcare professionals that cases of severe liver injury with hepatic failure have been reported in patients treated with the medicine Ontozry. Most cases occurred when the medicine was used alongside other anti-seizure medications.

Prescribers are recommended to conduct liver function tests before starting treatment with Ontozry and throughout treatment.

They should carry out a prompt clinical evaluation and liver function tests in patients who have symptoms indicating liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

Patients should be advised to immediately seek medical attention if they experience signs or symptoms suggesting liver injury.

If liver injury is suspected or detected, dose reduction…