Novo's Ozempic, Wegovy linked to rare cases of dangerous eye disorder, EMA says
June 6 (Reuters) - The European Medicines Agency's safety committee has concluded that the use of Novo Nordisk's (NOVOb.CO), opens new tab popular weight-loss drug Wegovy and its treatments for type 2 diabetes may cause rare occurrences of a potentially dangerous eye condition.
Called non-arteritic anterior ischemic optic neuropathy (NAION), the condition may affect up to 1 in 10,000 people taking semaglutide, the active ingredient in Wegovy and Novo's diabetes drugs Ozempic and Rybelsus, the regulator said on Friday.
The EMA, which started its review in December, said the use of the drugs is linked to about twofold increase in the risk of developing the condition compared to people not taking the medicine.
NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma.
Studies have linked semaglutide to NAION in the past. But this is the first time a regulator has made the link.
Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, which work by helping control blood sugar levels and triggering a feeling of fullness.
A large study of nearly 350,000 diabetics published earlier this year had showed that the risk of developing NAION more than doubled after long-term use of semaglutide, compared to patients taking medicines from other classes.
The EMA said it has reviewed all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials and post-marketing surveillance.
It has recommended the drugmaker to update prescribing information for medicines containing semaglutide to include NAION as a side effect with a frequency of "very rare".
The U.S. Food and Drug Administration did not immediately respond to a Reuters request for comment.
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'Excessive hydration' 8 Were you to browse through weight loss content on TikTok, it's likely that creators will include drinking lots of water in their lists of tips. Some will advise keeping a filled water bottle on you at all times, while others prescribe amounts such as three litres or gallon a day - which to Lucy seemed ludicrous. 'There are benefits to hydration from a concentration perspective, from a bowel perspective. 'So, for me hydration is key - but healthy hydration in line with the guidance, six to eight glasses a day. 'From a weight loss perspective, I don't think there is any solid evidence to be recommending it.' She mentioned that some creators claim drinking water will help 'flush out' your digestive system. How to spot weight loss fads on TikTok 'Have a look at who is posting it, what is their background, what is their profession,' Lucy advised. Follow up by doing your research - check if there are large, clinical trials that back up health advice you're coming across. If you suspect someone is making unsafe claims on TikTok: Go to the specific video Tap the 'Share' button (arrow icon) Tap 'Report' (flag icon) Select a reason. Choose 'Misleading Information' or 'Health and Safety' (depending on what's available in your region and TikTok version). If it's medical or nutritional misinformation, select: 'Misinformation' → 'Health Information Add comments (optional but helpful!) Mention why it's unsafe (e.g., 'Promotes starvation diet under 500 calories/day,' 'Encourages unproven supplements'). 'It's rare, but it can be dangerous to be flushing huge amounts through your body, through your kidney,' Lucy warned. But the dietitian did acknowledge that 'sometimes hunger cues can be confused with thirst', so staying well hydrated throughout the day is key. 'It's quite an old school [tip], have a glass of water before your meal,' she said, pointing out that there is some 'small evidence' that having water before a meal may result in modest weight loss - but only 'in combination with following calorie reduced diets'. Another study from 2009 showed that people ate fewer calories if they water before meals. 'Hydration is great, overhydration is crazy,' Lucy stressed. 7. Olive oil shots Social media users have claimed that taking a shot of olive oil in the morning could 'kickstart' your metabolism and help with weight loss. But Lucy wasn't so sure about the unorthodox hack. 'Olive oil has its health benefits - from a cardiovascular disease perspective it definitely has its place at the table. 'But when it comes to a weight loss tool, I have not seen convincing evidence for it. 'It isn't a magic quick fix because a tablespoon of olive oil is the same calorie-wise as a tablespoon of fat, so it's not saving you any calories.' It probably won't do much for your gut health either - fibrous food and probiotics are much more likely to help, the dietitian went on. Stick to drizzling olive oil on your salad rather than shotting it, Lucy advised.
