The European Medicines Agency's safety committee has concluded that a potentially dangerous eye condition is a very rare side effect of Novo Nordisk's popular treatments Ozempic and Wegovy, it said on Friday.
The condition called non-arteritic anterior ischemic optic neuropathy (NAION) may affect up to 1 in 10,000 people taking semaglutide, the chemical name for Wegovy and Ozempic, the EMA said.
The regulator, which started its review in December, said use of the drugs is linked to about twofold increase in the risk of developing the condition compared to people not taking the medicine.
Studies have linked semaglutide to NAION in the past. But this is the first time a regulator has made the link.
The EMA has recommended the drugmaker to update prescribing information for medicines containing semaglutide to include NAION as a side effect with a frequency of "very rare."
NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma.
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