The European Medicines Agency’s (EMA) safety committee, PRAC, has concluded that semaglutide medicines may cause a rare but serious eye condition called NAION, which can lead to loss of vision. Treatment with semaglutide should be stopped immediately if NAION occurs.
PRAC has also warned about the risk of encephalitis (inflammation of the brain) associated with two varicella vaccines, Varilrix and Varivax. The warning comes after a fatal outcome was reported in Poland after vaccination with Varilrix.
The PRAC recommended updating the product information for semaglutide medicines to include NAION as a side effect with a frequency of “very rare” (up to 1 in 10,000 people). Patients should contact their doctor immediately if they experience sudden vision loss or rapidly worsening eyesight during treatment.
Meanwhile, EMA is investigating the risk of encephalitis associated with varicella vaccines. The vaccines can still be used while the investigation continues, but patients should be aware of the potential risks and report any adverse events to their doctor.
The PRAC review highlights the importance of monitoring medicines for potential safety signals and taking swift action to protect public health.
Source: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-june-2025