By Radarr Africa Business Desk
NEW YORK, November 12 (Radarr Africa) – The US Food and Drug Administration (FDA) is requiring the makers of all GLP-1 medications to add a warning about a potential increased risk of nonarteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can cause sudden loss of vision.
The agency announced the requirement on Monday, November 9, after reviewing clinical trials, real-world patient data and published studies. NAION is caused by decreased blood flow to the front part of the optic nerve, and the underlying cause is not completely understood. It can lead to permanent vision loss.
The FDA said a causal relationship between NAION and GLP-1 drugs has not been established, but that cases have been reported for all currently marketed GLP-1 products.
In its analysis of 126 trials involving more than 134,000 patients, the NAION rate was 6.4 cases per 100,000 patient-years among GLP-1 users, against 3.8 among patients receiving other treatments or placebo. Several observational studies also identified an increased risk, the agency said.
The products named include Novo Nordisk’s Ozempic and Wegovy, which contain semaglutide, and Eli Lilly’s Mounjaro, Zepbound and Foundayo. Mounjaro’s active ingredient is tirzepatide.
Analysts at Citi said the action is likely to attract attention but should have limited impact on GLP-1 uptake. They noted that NAION’s rarity and the drugs’ weight, glycaemic, cardiovascular, renal and sleep apnoea benefits should preserve a favourable benefit-risk profile.
Many GLP-1 drugs already carry a boxed warning about potential thyroid tumours. Studies showed that semaglutide and tirzepatide cause thyroid C-cell tumours in rodents, and it is unknown whether they cause these tumours, including a rare thyroid cancer, in humans.
The warning is a labelling change and does not remove any product from sale.
