EMA News

Severe Liver Injury Warning for Epilepsy Drug Ontozry

PRAC agreed on a Direct Healthcare Professional Communication for Ontozry (cenobamate) warning of severe liver injury cases with hepatic failure, most occurring when used alongside other anti-seizure medications. The committee recommended adding liver injury as a rare side effect (up to 1 in 1,000) to product information and issued new liver monitoring requirements for prescribers throughout treatment.

EMA PRAC Warns of Aseptic Meningitis Risk with Ixchiq Vaccine

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the product information for the chikungunya vaccine Ixchiq to reflect recent evidence of aseptic meningitis risk, particularly in healthy young adults. This follows a safety signal investigation and is part of a regular safety assessment.