Bridging the gap between academic research and real-world solutions
In the pursuit of scientific advancement, the journey from theoretical research to tangible solutions is often fraught with challenges.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that non-arteritic anterior ischemic optic neuropathy (NAION) is a very rare side effect of semaglutide, a drug used to treat diabetes and obesity. This follows a safety review triggered by concerns about vision loss associated with semaglutide-containing medicines, including Ozempic, Rybelsus, and Wegovy. NAION is a serious eye condition that can lead to vision impairment or loss. After assessing all available data, PRAC recommended updating the product information to include NAION as a side effect that may affect up to 1 in 10,000 people. Patients experiencing sudden or rapidly worsening vision loss should immediately consult their doctor. If NAION is diagnosed, semaglutide treatment should be discontinued.
In a separate development, PRAC has initiated a review of the risk of encephalitis associated with varicella vaccines Varilrix and Varivax. The review follows a fatal case in Poland involving a child who developed encephalitis shortly after receiving a dose of Varilrix. The child died a few days later from complications of the condition. Encephalitis, or inflammation of the brain, is already listed as a rare side effect in the vaccines’ product information.
Varilrix and Varivax are live attenuated vaccines used across the EU for immunisation against chickenpox in both children and adults. Chickenpox, caused by the varicella-zoster virus, typically affects children aged 2–8 and is usually mild. However, it can lead to serious complications such as bacterial infections, pneumonia, and encephalitis. The reported case in Poland prompted local authorities to suspend the distribution of the vaccine batch involved as a precautionary measure.
PRAC will now thoroughly evaluate all available evidence to determine whether additional regulatory action is warranted. In the meantime, both vaccines remain authorised and can continue to be used according to their current prescribing guidelines.
