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PRAC concludes eye condition NAION is a very rare side effect of semaglutide medicines
Treatment with semaglutide should be stopped if NAION occurs
EMA’s safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause loss of vision. Semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used in the treatment of diabetes and obesity (namely Ozempic, Rybelsus and Wegovy).
After reviewing all available data on NAION with semaglutide, PRAC has recommended that the product information for semaglutide medicines is updated to include NAION as a side effect with a frequency of ‘very rare’ (it may affect up to 1 in 10,000 people). If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay. If NAION is confirmed, treatment with semaglutide should be stopped.
More information is available in EMA’s public health communication.
PRAC reviewing risk of encephalitis with varicella vaccines
EMA’s safety committee (PRAC) is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella (chickenpox) vaccines, Varilrix and Varivax, following a report of a fatal outcome after vaccination with Varilrix.
Varilrix and Varivax are authorised for vaccination of adults and children from 12 months of age, and in certain populations from 9 months of age, against chickenpox. They contain live attenuated (weakened) varicella virus.
Varicella is caused by the varicella-zoster virus, which also causes shingles (herpes zoster). Varicella mainly affects children aged 2-8 years where it is usually a mild disease and children recover quickly. In some cases, varicella can cause complications including bacterial infection of the skin or blood, pneumonia (infection and inflammation of the lungs) and encephalitis. Encephalitis can also be caused by other viral or bacterial infections. While most people with encephalitis recover, the condition can be life-threatening.
This review was initiated by the PRAC following a case report in Poland of a child who developed encephalitis a few days after receiving the Varilrix vaccine. The patient died of the consequences of encephalitis several days later. As a precaution, the Polish medicines agency has suspended the distribution of vaccines from the batch in question.
These vaccines are widely used across the EU, and encephalitis is listed as a side effect in their product information based on rare reports during post-marketing surveillance.
The committee will now assess all available evidence to better understand the risk of encephalitis and to determine if any regulatory action is necessary.
While EMA is investigating the issue, the vaccines can continue to be used in line with the approved product information.
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