FDA issues warning to Ozempic, Wegovy and other GLP-1 users over 'eye stroke' risk

Users of Ozempic, Wegovy and other GLP-1s have been issued with a warning over a potential eyesight risk which prompted changes to labelling.

The U.S. Food and Drug Administration (FDA) has mandated safety label updates for the medications like Ozempic and Wegovy to reflect a potential link to non-arteritic anterior ischemic optic neuropathy (NAION).

This is a rare and serious condition also known as an 'eye stroke' and can cause permanent vision loss.

The FDA said it is requiring the drugs to add clear information to the 'warning and precautions' section of labelling about the potential increased risk of NAION.

Users of the drugs have been informed of the potential risk (Getty Stock)

According to the NHS, it is a condition where reduced blood flow to the front part of the optic nerve causes sudden, painless vision loss, often described as a shadow, cloudiness, or a blank area.

It is often referred to as a 'stroke' of the optic nerve, though it happens without inflammation of the blood vessels. The condition is a common cause of sudden, painless vision loss, and may lead to permanent impairment of sight in some cases.

It is caused by decreased blood flow to the front part of the ​optic nerve, but the underlying cause is not completely understood.

The new move comes after a review into NAION in patients who were taking the drugs. The FDA analysis found about six cases of NAION per 100,000 people taking GLP-1 drugs every year.

“NAION cases have been reported for all currently marketed GLP-1 RA products,” the FDA said. “FDA concluded that there is a potential increased risk of rare NAION events in patients taking GLP-1 RAs.”

The FDA has informed users of the drugs (Getty Stock)

This compared with about four cases among those taking a placebo or other diabetes medication. “Patients with a history of NAION are at increased risk of recurrence,” the FDA noted.

In a statement to LADbible Group, Novo Nordisk, who manufactures the likes of Ozempic and Wegovy, said: "The US FDA is requiring a class-wide labeling update for GLP-1 receptor agonist medicines to include information about a potential increased risk of a rare eye condition, NAION (non-arteritic anterior ischemic optic neuropathy).

"The FDA concluded that there is a 'potential increased risk' of NAION with GLP-1 use. This update will apply to all manufacturers of GLP-1 medicines.

"Novo continues to believe the data do not establish a cause-and-effect relationship and we remain confident in the benefit-risk profile of our GLP-1 medicines.

"We recognise that NAION can have a profound impact on patients and their families. Patient safety is a top priority for Novo, and we continue to monitor the safety of our medicines, review new research and work with health authorities around the world."