June 6 (Reuters) - 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.