{"text":[[{"start":0,"text":"Novo and Eli Lilly must add a warning to their weight-loss drug labels about the potential risk of permanent vision loss associated with the blockbuster GLP-1 medicines, a US regulator has said."}],[{"start":18.56,"text":"The Food and Drug Administration said on Monday it was informing patients and healthcare providers about a potential increased risk of a rare but serious eye condition that can result in “acute, painless, decreased vision in one eye, including permanent vision loss” that was associated with the use of GLP-1s."}],[{"start":36.96,"text":"The agency said it would require companies such as US drugmaker Lilly, Denmark’s Novo and other makers of GLP-1 receptor agonists to add information to the warnings and precaution section of their labelling about the potential increased risk of the condition, known as non-arteritic anterior ischemic optic neuropathy (Naion)."}],[{"start":56.16,"text":"The FDA’s decision is likely to stir debate about the impact of the drugs, including their physical side effects as well as the broader economic consequences stemming from potential changes to activity and spending among users."}],[{"start":68.32,"text":"The FDA said Naion cases had been reported for all currently marketed GLP-1 products and, following its own reviews and analysis, “concluded that there is a potential increased risk of rare Naion events in patients taking GLP-1 RAs”."}],[{"start":83.16,"text":"Novo said patient safety was a “top priority” and that it would continue to monitor the safety of its medicines and work with health authorities around the world. “We recognise that Naion can have a profound impact on patients and their families,” the company said on Monday, adding that it “remained confident” that the benefits of the GLP-1 drugs outweighed the risks."}],[{"start":103.8,"text":"“Novo continues to believe the data do not establish a cause-and-effect relationship and we remain confident in the benefit-risk profile of our GLP-1 medicines,” it said."}],[{"start":113.72,"text":"Lilly said the FDA’s statement applied to all GLP-1 medicines and did not single out its weight-loss drugs specifically. “We are carefully evaluating the update and will respond to the FDA promptly,” it said, adding that patient safety was the company’s “top priority”."}],[{"start":129.04,"text":"Monday’s announcement referred to a July 2024 article in the peer-reviewed medical journal Jama Ophthalmology about the risk of Naion among GLP-1 users. The FDA said it “identified several limitations” of this study, but decided that further assessment of the potential risk was warranted."}],[{"start":148.76,"text":"The agency said that after the study came out it undertook a “comprehensive evaluation of clinical trial data, animal data, and postmarketing data, including observational studies and case reports.”"}],[{"start":161.08,"text":"It said it conducted a meta-analysis of clinical trials, the results of which showed a Naion incidence rate of 6.4 events per 100,000 person years in subjects treated with GLP-1s, compared with 3.8 events per 100,000 patient years for those treated with the control treatment."}],[{"start":179.96,"text":"Lilly’s shares gained 4.5 per cent in afternoon trading in New York while Novo shares rose 1.2 per cent over the course of the day in Copenhagen."}],[{"start":189.88,"text":"Additional reporting by Hannah Kuchler and Patrick Temple-West in London"}],[{"start":198.24,"text":""}]],"url":"https://audio.ftcn.net.cn/album/a_1794276975_2135.mp3"}