The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has completed several safety reviews involving valproate, the chikungunya vaccine Ixchiq, and the vasculitis medicine Tavneos.

Valproate: Inconsistent Evidence on Neurodevelopmental Risk in Children of Male Patients

After reviewing the latest data, PRAC concluded that evidence on neurodevelopmental disorders in children born to men treated with valproate is inconsistent and a causal role of the medicine remains uncertain. A 2024 study had suggested a potential increased risk, but a subsequent Danish nationwide study found no such association. Most retrospective observational studies also failed to confirm an elevated risk. Due to differences in study design, PRAC could not rule out the influence of factors such as the father's underlying medical condition. Precautionary measures introduced in 2024 will remain in place pending results from a larger study expected in 2028, and product information will be updated accordingly. Valproate is used to treat epilepsy and bipolar disorder, and in some EU countries, migraine prevention.

Ixchiq Vaccine: Restricted to High-Risk Individuals

PRAC recommended restricting the use of the chikungunya vaccine Ixchiq to individuals at high risk of infection. The vaccine is indicated for people aged 12 and older. A routine safety review identified serious adverse events including aseptic meningitis, with some cases resulting in hospitalization or death. Severe side effects occurred mainly in those aged 65 and older and patients with multiple chronic conditions, though younger healthy adults were also affected. The committee stressed that the vaccine should only be given to high-risk individuals after careful assessment of benefits and risks. It is contraindicated in immunocompromised patients and should not be co-administered with other vaccines.

Tavneos: Strengthened Liver Monitoring Requirements