Agenzia Italiana del Farmaco
Meeting highlights from PRAC (8-11 June) - Meeting highlights from PRAC (8-11 June)
Meeting highlights from PRAC (8-11 June)
At its June 2026 meeting, the PRAC adopted relevant recommendations on the safety of medicines, in particular:
Valproate and potential risk of neurodevelopmental disorders: the review of paternal exposure data was concluded, with inconsistent evidence and an unconfirmed causal link; the maintenance of precautionary measures and the updating of the product information to reflect the most recent data were recommended.
Chikungunya Vaccine (Ixchiq) and risk of serious adverse events: PRAC recommended restricting the use of the chikungunya vaccine Ixchiq to individuals at high risk of infection, following the evaluation of safety data and benefit/risk balance. The PRAC also recommended issuing a direct healthcare professional communications to inform them about the new recommendations.
Tavneos (avacopan) and risk of liver injury: further risk minimization measures have been introduced, including reinforced liver function monitoring requirements and stopping rules to mitigate risk of serious liver injury. The PRAC also recommended issuing a direct healthcare professional communications to inform them about the new recommendations.
Published on: 12 June 2026
