European Drug Regulators Are Investigating Semaglutide-Related NAION Cases Presented in Two Danish Studies
(Posted by Tom Lamb at Drug Injury Watch)
According to this December 18, 2024, Reuters news report, "Novo Nordisk's Ozempic faces EU review for potential eye disease connection", there is a significant development concerning semaglutide drugs like Ozempic linked to vision loss and blindness:
The European Union's drug regulator said it would assess two new Danish studies that link Novo Nordisk's popular diabetes drug Ozempic to a rare eye disease.
The studies published earlier this week had found Ozempic significantly increases the risk of type 2 diabetes patients developing NAION (non-arteritic anterior ischemic optic neuropathy), more than doubling the likelihood. [emphasis added]
The European Medicines Agency (EMA) said late on [December 17, 2024] that the reviewed evidence from other research so far had not been strong enough to suggest a possible link between Ozempic and the eye disease but that the two Danish studies may hold new important information.
To provide context for this new European regulatory action on the drug safety issue of Ozempic linked to vision loss, we direct you to this December 16, 2024, Bloomberg article, "Ozempic Blinding Link in Study Prompts Agency to Seek Probe":
The Danish Medicines Agency said it would ask European authorities to review two new studies that point to a link between Novo Nordisk A/S’s blockbuster shot Ozempic and a rare form of vision loss.
The national regulator will call on the European Committee for the Evaluation of Adverse Reactions, or PRAC, to assess the Danish registry studies, the agency said [December 16, 2024].
A pair of large studies from the University of Southern Denmark “strengthen the suspicion” of a link between Ozempic and the rare eye condition, called NAION, the agency said.
Conducted independently, the studies both found that people who took Ozempic faced more than twice the risk of the eye condition, which can cause blindness. Both appear to confirm a link first suggested earlier this year in a Harvard University study....
One of the two studies to prompt the call for a review appeared last week on medRxiv, a website that posts studies before they’re reviewed by outside scientists....
The second study examined data from about 424,000 Danish diabetes patients, of whom a quarter received Ozempic, and has been accepted for publication in the International Journal of Retina and Vitreous.
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The first study mentioned above, "Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study", was posted online on December 11, 2024. From the Abstract for that Danish study:
- Importance Recent findings have raised concerns about an association between semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), and non-arteritic anterior ischemic optic neuropathy (NAION).
- Objective To further investigate the putative association between semaglutide use and NAION.
- Participants New users of semaglutide and sodium-glucose co-transporter 2 inhibitors (SGLT-2is) during 2018-2022 (Norway) and 2018-2024 (Denmark).
- Results We identified 44,517 eligible users of semaglutide for the management of type 2 diabetes in Denmark and 16,860 in Norway. In total, we observed 32 NAION events among semaglutide users (24 in Denmark and 8 in Norway). This yielded an unadjusted incidence rate of NAION of 2.19/10,000 person-years among Danish semaglutide initiators, compared to 1.18 among SGLT-2i initiators. The corresponding unadjusted incidence rates in Norway were 2.90 and 0.92. After adjustment, we obtained a pooled [hazard ratios (HR)] of 2.81 (95% CI 1.67 to 4.75)...
- Conclusions and Relevance Our findings show an association between use of semaglutide for type 2 diabetes and risk of NAION. However, the absolute risk remains low.
In closing, from our earlier reporting on this drug safety issue of Ozempic linked to vision loss, "Wegovy, Rybelsus, and Ozempic Eye Side Effects: Semaglutide Linked to NAION":
We are interested in hearing from patients who developed [nonarteritic anterior ischemic optic neuropathy (NAION)] following the use of Ozempic, Wegovy, or Rybelsus. We point out that NAION is sometimes referred to more simply as an “eye stroke" and, as it is a form of "optic neuropathy" (an eye disease category), NAION may be noted only as optic neuropathy in the medical records.
Patients who have been diagnosed with semaglutide-related NAION and experienced blindness or vision loss may be entitled to legal compensation by filing a drug injury lawsuit against Novo Nordisk, the pharmaceutical company responsible for Ozempic, Wegovy, and Rybelsus.
We will continue to monitor the drug regulatory realm for more developments concerning semaglutide drugs like Ozempic linked to vision loss and blindness.
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