- Published
The US Food and Drug Administration (FDA) told makers of popular weight-loss GLP-1 drugs that they must add warning labels about a rare eye condition that can cause sudden blindness.
asserted
that → publish → blindness
Manufacturers of Ozempic, Wegovy, Mounjaro and Zepbound must warn about nonarteritic anterior ischemic optic neuropathy (NAION).
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Manufacturers → warn → neuropathy
The disorder happens when vessels supplying blood to the optic nerves become blocked, depriving the nerves of oxygen.
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vessels → happen → oxygen
The condition can cause painless decreased vision in one eye, which can be permanent, the FDA said.
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FDA → cause → eye
In a statement to the BBC, the American Academy of Ophthalmology said "any added risk appears small, and it has not been established that these medications cause NAION".
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medications → say → NAION
"GLP-1 medications offer important benefits for people with diabetes, obesity, and heart disease, so our message to patients is simple," the group said.
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group → offer → patients
"Don't stop your medication without talking to your doctor, and if you notice sudden, painless vision loss in one eye, see an ophthalmologist promptly."
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you → stop → ophthalmologist
It is the most common cause of acute optic nerve injury in people over 50 years old, according to the academy.
uncertain
It → accord → academy
The FDA said it conducted a detailed review of reports of NAION in GLP-1 users as well as a review of other studies and concluded there is an "increased risk of rare NAION events" in people taking the drugs.
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it → say → drugs
In a statement, Novo Nordisk, the manufacturer of Wegovy, one of the most popular weight-loss medications, said the company believes the data "do not establish a cause-and-effect relationship".
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data → say → relationship
"We recognize that NAION can have a profound impact on patients and their families.
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NAION → recognize → patients
Patient safety is a top priority for Novo, and we continue to monitor the safety of our medicines," the manufacturer said.
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manufacturer → continue → medicines
Some research was challenging to review because people taking GLP-1 drugs for obesity and type 2 diabetes may already have risk factors for NAION separate from the drugs, according to the regulator.
uncertain
people → review → regulator
The FDA said it was not known why those taking GLP-1 drugs may be more at risk for the eye condition.
uncertain
those → say → condition
The drugs already have warning labels for several other conditions including pancreatitis and gallbladder disease.
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drugs → have → pancreatitis
Some of the most common symptoms for semaglutide - a key ingredient in many GLP-1 drugs - include nausea, vomiting and stomach pain.
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Some → include → nausea
Last year, a safety arm of the European Medicines Agency, a part of the European Union, said up to 1 in 10,000 people taking semaglutide may be affected by NAION.
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people → say → NAION
In a study published two years ago analysing 17,000 patients, US researchers found those taking semaglutide were four times more likely to be diagnosed with NAION than those not taking the drug.
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those → publish → drug
But one of the authors of the study, Harvard Medical School ophthalmology professor Dr Joseph Rizzo, said the findings were "significant but tentative", and more research was needed on the relationship between the drug and the eye condition in a more diverse population.
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research → say → population
The Aporia
