Italian Medicines Agency 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

Asset Publisher

Asset Publisher

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

Asset Publisher

Asset Publisher

Galleria

Cookie Bar

cookie management module

Descrizione cookieBar

Questo sito utilizza cookie tecnici e analytics, necessari al suo funzionamento, per i quali non è richiesto il consenso. Per alcuni servizi aggiuntivi, le terze parti fornitrici, dettagliatamente sotto individuate, possono utilizzare cookies tecnici, analytics e di profilazione. Per saperne di più consulta la PRIVACY POLICY. Per proseguire nella navigazione devi effettuare la scelta sui cookie di terze parti dei quali eventualmente accetti l’utilizzo. Chiudendo il banner attraverso la X in alto a destra rifiuti tutti i cookie di terze parti. Puoi rivedere e modificare le tue scelte in qualsiasi momento attraverso il link "Gestione cookie" presente nel footer.

Social networks
go to beginning of content