引 致 更 改 給 病 人 的 產 品 資 訊 的 藥 物 不 良 反 應 警 示
|
| |
| European Union: Ontozry (cenobamate): new requirements for liver monitoring due to reports of severe liver injury (English only) |
| |
European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) agreed on a direct healthcare professional communication 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 or discontinuation of Ontozry should be considered, in line with the guidelines of the summary of product characteristics (i.e., unless required, avoid abrupt discontinuation to minimise the risk of rebound seizures).
Increased liver enzyme levels are already listed in Ontozry’s product information as a common side effect (which may occur in up to 1 in 10 people).
Following its review of the cases, PRAC recommended adding liver injury as a rare side effect (which may occur in up to 1 in 1,000 people) to Ontozry’s product information and including warnings for patients and healthcare professionals.
Ontozry is a medicine for treating epileptic seizures starting in one specific part of the brain (focal seizures), including those that eventually spread to the whole brain (secondary generalisation). It is used as an add-on to other epilepsy medicines for adults with seizures that are not controlled despite having tried at least two other treatments.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-april-2026
In Hong Kong, there are 9 registered pharmaceutical products containing cenobamate. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction with regard to cenobamate. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board of Hong Kong.
Ends/ Saturday, Apr 11, 2026
Issued at HKT 12:00
|
| |
|
