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GLP-1s and NAION: Do Patients Need a Warning?
Confirmed
In Short: Clinicians and patients need to consider the potential risk of nonarteritic anterior ischemic optic neuropathy (NAION) when using GLP-1 drugs, experts argue.
Clinicians and patients need a signal to prompt more consideration of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition, when using GLP-1 drugs, according to Jonathan Orent, JD, of the law firm Motley Rice.
In a joint consensus statement issued in May, the American Academy of Ophthalmology Board of Trustees and the North American Neuro-Ophthalmology Society noted that research findings on NAION in patients taking GLP-1 drugs have been mixed.
Ophthalmologists should also keep the reports of NAION in mind when treating patients taking GLP-1 drugs, Rudrani Banik, MD, associate professor of ophthalmology at the Icahn School of Medicine at Mount Sinai, said.
The litigation and publicity surrounding these drugs may prompt patients and clinicians to more carefully weigh the rare potential risk for NAION when making decisions about GLP-1 drugs, Banik added.
Orent, who is co-lead attorney in federal multidistrict litigation (MDL) involving allegations of NAION associated with GLP-1 drugs, argues that adding a warning to the label would make clinicians and patients more likely to consider the potential risk for NAION when making prescribing decisions.
To date, US labels for the semaglutide products Ozempic and Wegovy (Novo) do not contain information about NAION, and attorneys representing plaintiffs in product liability cases contend that the lack of such information puts US clinicians and patients at a disadvantage.
Experts for the plaintiffs testified that if GLP-1s were to double the risk, it could become more consequential, particularly among patients with smaller-than-average optic discs who use the drugs for several years.
The groups also noted that most patients with NAION have the so-called “disc at risk,” or a small or crowded optic disc with a tiny or absent cup, which may predispose the optic nerve to ischemia.
However, top medical organizations in ophthalmology have not concluded that causation exists between GLP-1 drugs and NAION, according to attorneys representing Eli Lilly and Novo.
Cases have also been filed involving Eli Lilly’s dual GLP-1/GIP tirzepatide (Mounjaro and Zepbound), although the European Medicines Agency’s current warning applies only to semaglutide.
No firm timelines have been set for decisions in the NAION litigation, known as MDL-3163, or in related litigation, MDL-3094, involving allegations of gastroparesis and other gastrointestinal injuries.
The whole conversation should be about raising awareness but not causing panic, Banik said.
What this adds
The report adds that medical conditions commonly associated with GLP-1 drugs, such as diabetes and sleep apnea, may increase the risk for NAION.
The litigation and publicity surrounding these drugs may prompt patients and clinicians to more carefully weigh the rare potential risk for NAION when making decisions about GLP-1 drugs.
What's confirmed
- Clinicians and patients need a signal to prompt more consideration of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition, when using GLP-1 drugs, according to Jonathan Orent, JD, of the law firm Motley Rice.
- In a joint consensus statement issued in May, the American Academy of Ophthalmology Board of Trustees and the North American Neuro-Ophthalmology Society noted that research findings on NAION in patients taking GLP-1 drugs have been mixed.
- Ophthalmologists should also keep the reports of NAION in mind when treating patients taking GLP-1 drugs, Rudrani Banik, MD, associate professor of ophthalmology at the Icahn School of Medicine at Mount Sinai, said.
- The litigation and publicity surrounding these drugs may prompt patients and clinicians to more carefully weigh the rare potential risk for NAION when making decisions about GLP-1 drugs, Banik added.
- Orent, who is co-lead attorney in federal multidistrict litigation (MDL) involving allegations of NAION associated with GLP-1 drugs, argues that adding a warning to the label would make clinicians and patients more likely to consider the potential risk for NAION when making prescribing decisions.
- To date, US labels for the semaglutide products Ozempic and Wegovy (Novo) do not contain information about NAION, and attorneys representing plaintiffs in product liability cases contend that the lack of such information puts US clinicians and patients at a disadvantage.
- Experts for the plaintiffs testified that if GLP-1s were to double the risk, it could become more consequential, particularly among patients with smaller-than-average optic discs who use the drugs for several years.
- The groups also noted that most patients with NAION have the so-called “disc at risk,” or a small or crowded optic disc with a tiny or absent cup, which may predispose the optic nerve to ischemia.
- However, top medical organizations in ophthalmology have not concluded that causation exists between GLP-1 drugs and NAION, according to attorneys representing Eli Lilly and Novo.
- Cases have also been filed involving Eli Lilly’s dual GLP-1/GIP tirzepatide (Mounjaro and Zepbound), although the European Medicines Agency’s current warning applies only to semaglutide.
- No firm timelines have been set for decisions in the NAION litigation, known as MDL-3163, or in related litigation, MDL-3094, involving allegations of gastroparesis and other gastrointestinal injuries.
- The whole conversation should be about raising awareness but not causing panic, Banik said.
What's still developing
- “Those are the kind of things that warning labels can provide. And that’s why it’s important for doctors to be aware of what the likelihood of a patient to stay on a drug is,” Orent said.
- “We need to ask more questions, probe, and maybe have a discussion with the prescribing doctor about whether the patient’s a good candidate,” for a GLP-1, Banik said.
- “It doesn’t mean that they’re winners,” said Rave, speaking of MDLs in general.
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