Agenzia Italiana del Farmaco
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 june 2025 - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 june 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 june 2025
Semaglutide
The PRAC has concluded its review of semaglutide-containing medicines (Ozempic, Rybelsus, Wegovy).
- The PRAC confirmed that NAION, a serious ocular condition that may cause loss of vision, is a very rare side effect of these medicines.
- If sudden loss of vision or rapidly worsening eyesight is experienced, a doctor should be contacted without delay.
- If NAION is confirmed, treatment with semaglutide should be stopped.
PRAC reviewing risk of encephalitis with varicella vaccines
The PRAC is carefully examining all available information regarding a very rare risk of encephalitis associated with varicella vaccines.
- In Poland, a case of severe inflammation of the brain (encephalitis) has been reported in a child after the administration of the Varilrix vaccine who died from this complication.
- As a precautionary measure, the distribution of the vaccine batch involved was suspended in Poland, batch never distributed in Italy.
- The PRAC is now evaluating all available evidence to better understand this risk and to determine if any regulatory action is necessary.
In the meantime, vaccines can continue to be used in line with approved product information.
Published on: 06 June 2025
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