Lawsuit alleges man with diabetes turned blind after taking Ozempic

A Maryland man who took Ozempic after which turned legally blind is suing the drug’s producer, arguing it had an obligation to warn sufferers that lack of sight may very well be a attainable facet impact.

Todd Engel, 62, was prescribed Ozempic in 2023 to handle his Kind 2 diabetes. The lawsuit mentioned about 4 months later, Engel was recognized with nonarteritic anterior ischemic optic neuropathy, or NAION, a situation by which a lack of blood movement to the optic nerve causes sudden and irreversible imaginative and prescient loss.

NAION happens in as much as about 10 out of each 100,000 individuals over age 50, in accordance to the American Academy of Ophthalmology.  

Ozempic and others in the identical class of medication, referred to as GLP-1s, have been designed for Kind 2 diabetes and have turn into wildly widespread for weight reduction in recent times.  

Some research have indicated that sufferers prescribed semaglutide, the energetic ingredient in Ozempic, for diabetes or weight reduction could also be at elevated danger of creating NAION. Consultants say whereas proof is rising that there’s an affiliation between Ozempic and NAION, it’s nonetheless too early to know definitively if semaglutide raises the danger of creating the situation — particularly as a result of diabetes itself is a danger issue for NAION and different eye points.

The lawsuit, filed late Thursday within the Superior Court docket of New Jersey, Middlesex County, accuses Novo Nordisk of negligence and mentioned it had an obligation to offer sufferers and physicians with details about the danger of significant eye issues. It mentioned Novo Nordisk had entry to data courting again as early as its Ozempic scientific trials that recognized instances of NAION but selected to not listing the situation on its warning label. 

“Nothing was or is stopping Defendant from including a warning concerning the danger of NAION,” the lawsuit mentioned. 

In a press release, a spokesperson for Novo Nordisk mentioned NAION just isn’t an adversarial drug response to Ozempic and different GLP-1s. Novo Nordisk mentioned its benefit-risk profile of semaglutide “stays unchanged” after a radical analysis of research from the College of Southern Denmark and an inside security evaluation, which didn’t counsel a causal relationship between GLP-1 use and NAION.  

The corporate added that it takes studies of adversarial occasions severely. 

“This additionally pertains to eye situations, that are well-known comorbidities for individuals residing with diabetes. Any choice to begin remedy with prescription-only medicines ought to be made in session with a healthcare skilled who ought to do a benefit-risk analysis for the affected person in query, weighing up the advantages of remedy with the potential dangers,” the spokesperson mentioned. 

Jonathan Orent, an legal professional for Engel who works for plaintiff litigation agency Motley Rice, mentioned Engel first skilled lack of imaginative and prescient in a single eye earlier than ultimately changing into legally blind in each. The attention issues compelled him to resign from his job as a motor tools operator for his county’s public works division, made it inconceivable for him to drive and have ceaselessly modified how he interacts with household and pals.

“He made a remark to me about the way it’s painful to know he’s by no means going to see his spouse smile once more, however he is aware of her voice so effectively, he can inform when she is smiling,” Orent mentioned.

He mentioned if Engel had identified Ozempic had a attainable hyperlink to blindness, he would have thought-about different remedy choices. 

“There are a large variety of medicines that can be utilized to deal with diabetes, and deal with it successfully,” Orent mentioned.

The lawsuit just isn’t the primary of its form. One other regulation agency not too long ago filed a comparable go well with towards Novo Nordisk.

The litigation comes amid ongoing questions over the hyperlink between the drug and NAION. A 2024 research discovered that individuals with diabetes who take semaglutide are over 4 instances extra more likely to be recognized with NAION than individuals with diabetes who had not been prescribed it. Those that have been obese or overweight and didn’t have diabetes have been over seven instances extra more likely to be recognized with NAION than those that had not been prescribed it, the research discovered. However the researchers cautioned that extra research are wanted to find out whether or not there’s a causal hyperlink between the irreversible imaginative and prescient issues and the medication, particularly as a result of it was a research based mostly on an evaluation of six years’ value of medical data from sufferers within the Boston space, not a randomized scientific trial. 

In February, a JAMA Ophthalmology research prompt a extra modest enhance within the danger of NAION amongst individuals with Kind 2 diabetes who take Ozempic, and likewise prompt additional investigation was vital. 

The Meals and Drug Administration declined to reply to questions on studies of a attainable affiliation between Ozempic and NAION, saying it doesn’t touch upon pending litigation. On the FDA’s Opposed Occasions Reporting System, a public dashboard, there are lots of of studies from 2024 of eye issues tied to Ozempic, although the FDA warns the dashboard information could comprise duplicates and the information has not been independently verified.

Dr. Andrew Lee, a spokesperson for the American Academy of Ophthalmology and a neuro-ophthalmologist at Houston Methodist Hospital, mentioned he’s longing for extra analysis to come back out on semaglutide, notably on whether or not it raises the danger for life-altering eye illnesses comparable to NAION.

“It’s an excellent necessary query to have the ability to reply whether or not Ozempic or any semaglutide causes NAION,” he mentioned. “There’s simply so many individuals on this drug.”

However sufferers who’re involved mustn’t rush off the drug with out talking to their medical doctors, he mentioned.

“How many individuals would you hurt in the event that they weren’t on it as a result of they bought a stroke or a coronary heart assault or bought another drawback?” he mentioned.

Engel’s lawsuit seeks damages and a jury trial.

“Hopefully his story will present that there’s one other facet to this drug that has purchased the repute as being a miracle drug,” Orent mentioned.