EMA tightens liver monitoring

The European Medicines Agency said doctors should now test liver function before and during treatment with Ontozry after reports of severe liver injury, including hepatic failure. (ema.europa.eu) The safety committee, the Pharmacovigilance Risk Assessment Committee, agreed the change on April 10, 2026 and said most reported cases happened when Ontozry was used with other anti-seizure medicines. (ema.europa.eu) Ontozry is the brand name for cenobamate, an add-on epilepsy drug for adults with focal-onset seizures, with or without secondary generalisation, after at least two other anti-epileptic medicines have not controlled the disease. (ema.europa.eu) Focal seizures start in one part of the brain, and some spread more widely. Ontozry is not used alone in the European Union indication; it is added to existing treatment. (ema.europa.eu) The committee said prescribers should order liver function tests before starting treatment and throughout treatment, and should quickly evaluate patients who develop fatigue, loss of appetite, pain in the upper right abdomen, dark urine, or jaundice. (ema.europa.eu) Patients should seek medical attention right away if those symptoms appear, the agency said. If liver injury is suspected or detected, doctors should consider lowering the dose or stopping Ontozry, while avoiding abrupt withdrawal unless necessary because of rebound seizure risk. (ema.europa.eu) The European Medicines Agency said increased liver enzymes were already listed as a common side effect, affecting up to 1 in 10 people. It now wants liver injury added as a rare side effect, affecting up to 1 in 1,000 people. (ema.europa.eu) The move came through the European Medicines Agency’s drug-safety system, which reviews side effects after medicines reach the market. The Pharmacovigilance Risk Assessment Committee sends its recommendations to the Committee for Medicinal Products for Human Use for centrally authorised medicines such as Ontozry. (ema.europa.eu) The agency said the communication will next go to the Committee for Medicinal Products for Human Use, and after adoption it will be sent to healthcare professionals and published in European Union national registers. (ema.europa.eu)