Novo's Ozempic Linked to Rare Cases Of Serious Eye Disorder, EU Regulator Says
(Reuters) -Novo Nordisk's popular weight-loss and diabetes drugs Wegovy and Ozempic may in very rare cases cause a serious eye condition that can lead to vision loss, the European Medicines Agency's safety committee said on Friday.
In the past, studies in type-2 diabetes patients have linked Ozempic to the condition called non-arteritic anterior ischemic optic neuropathy (NAION). But this is the first time a regulator has confirmed the side effect.
The condition may affect up to 1 in 10,000 people taking semaglutide, the active ingredient in Wegovy and Ozempic as well as in Novo's other diabetes drug Rybelsus, for at least one year, the regulator said.
NAION is the second-most common cause of blindness due to optic nerve damage, after glaucoma.
"This has been reported as a potential risk for some time, so I think the clinical community is relatively aware of it. I don't see this as making any major difference to prescribing patterns," said Barclays analyst Emily Field.
U.S.-listed shares of the Danish drugmaker were up nearly 2.5% in early trading.
The EMA, which started its review in December, has asked Novo to add NAION as a side effect of very rare frequency in the product information accompanying drugs that contain semaglutide.
Novo said it would work with the EMA to update the labels, adding clinical trials and after-market studies did not suggest a reasonable possibility that the drugs caused the condition.
The "benefit-risk profile of semaglutide remains favorable," the company said in a statement.
Novo has recently faced investor concerns that it is losing its first-mover advantage in the highly competitive obesity treatment market, leading the company to oust CEO Lars Fruergaard Jorgensen in May.
Wegovy and Eli Lilly's Zepbound currently dominate the weight-loss drug market, potentially worth about $150 billion by the next decade.
The EMA said several large studies in type-2 diabetes patients have suggested that use of Novo's drugs could raise the risk of developing NAION by twofold.
A study of nearly 350,000 diabetes patients published in March showed that the risk of developing NAION more than doubled after two years of treatment with Ozempic, compared to patients taking medicines from other classes.
The U.S. Department of Health and Human Services did not immediately respond to a Reuters request for comment on whether the Food and Drug Administration was conducting a probe into the side effect.
(Reporting by Manas Mishra and Mariam Sunny in Bengaluru; Editing by Shilpi Majumdar)
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
New York Post
an hour ago
- New York Post
Ozempic penis: Male users reveal shocking change to their genitalia after injecting weight-loss shot
It's the miracle drug that promises to shrink your size — except where it matters. Male Ozempic users say their penises have gotten bigger since they started injecting the weight-loss shot, with dozens of well-endowed fellas flocking to online forums to fawn over their expanded members. 'I recently measured myself down there and noticed I gained about one inch,' an anonymous user recently claimed on a Reddit thread. Advertisement 'Now I think people will say it was because of the fat loss. However at the time I measured myself before (4 years ago), I was thinner,' the man claimed. 'I also bone pressed during measurement before and also this time. Has anyone else noticed this change in themselves?' 3 Male Ozempic users say their penises have gotten bigger since they started injecting the weight-loss shot, with dozens of well-endowed fellas flocking to online forums to fawn over their expanded members. Shutterstock / Andrey_Popov 'Yes,' another happy Redditor responded. 'I gained 1.5 inches in length. No joke. Like you I obviously know how long I was before I got very fat. Then after about seven months on Tirzepatide in my case I gained 1.5 inches in length. Definitely not all from weight loss.' Advertisement 'I noticed that happen to me as well,' a third man remarked. 'Yeah, wife has definitely noticed a difference, was 278lbs down to under 200 lbs,' an additional commenter claimed. Meanwhile, other men also claimed that they had noticed a size difference after taking Ozempic, but put it down to better blood flow and reduced fat around the pubic area. Advertisement Another Redditor responded saying the size difference was likely due to different external conditions during the before and after measurements. 'I feel like nobody is really reading what you are writing, that they blame the weight loss while you measured the first time when you were actually lighter,' the explained. 'Ozempic does not enlarge your penis, but an erect penis may change size considerably depending on time of day, temperature, and factors other than sexual arousal. So it's probably just simply that.' 3 Some men also admitted that they had noticed a size difference after taking Ozempic, but put it down to better blood flow and reduced fat around the pubic area. myskin – Advertisement 3 Since it became widely available across America in 2024, users have reported an array of unexpected side effects. K KStock – The phenonemon — dubbed 'Ozempic penis' or 'Ozemd**k' — is just the latest in a series of side effects users of the weight-loss drugs have allegedly experencied. 'Ozempic mouth' is another recently reported side effect, marked by pronounced folds at the corners of the mouth, noticeable wrinkles on the lips, and sagging skin along the lip contours and chin area Those alarmed by their changed appearance are now turning to cosmetic treatments – such as dermal fillers – to restore lost volume around the mouth area.
New York Post
3 hours ago
- New York Post
Weight loss drugs like Ozempic could mess with your birth control — and get you pregnant
A UK watchdog is urging women on GLP-1 weight-loss drugs like Ozempic and Mounjaro to use effective forms of birth control after receiving more than 40 pregnancy-related reports linked to the medications. The warning comes as women flood social media with stories of their so-called 'Ozempic babies' — including surprise pregnancies while on the pill. Trying to shed pounds, not grow a baby bump? Here's what you need to know about GLP-1s, pregnancy and the best contraception options to stay protected. 4 Studies show that at least one in eight US adults have tried GLP-1s. íÅí°íâ¬í¸í½í° íâíµí¼íµíËí°í¾ – What's in your GLP-1? Several GLP-1 drugs dominate the market, including Ozempic and Wegovy. Both contain semaglutide, an active ingredient that mimics a natural hormone in the body that boosts insulin production, slows digestion and curbs appetite. Then there's Saxenda and Victoza, powered by liraglutide, which functions in a similar way. Newer drugs like Mounjaro and Zepbound rely on tirzepatide, a key ingredient that targets a second hormone involved in appetite and blood sugar control. A surprise side effect While gastrointestinal symptoms like nausea, vomiting and diarrhea are common with GLP-1s, the surprise side effect making waves is unexpected pregnancy. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has received 28 reports related to pregnancy in patients on tirzepatide, and nine each for semaglutide and liraglutide. 4 Women on tirzepatide-based GLP-1s should use barrier contraception. nenetus – In an alert this week, the agency warned that tirzepatide may reduce the effectiveness of oral contraceptives, especially in women with higher body weight. As a result, it recommended using barrier methods like condoms while on drugs like Mounjaro. So far, there's no evidence that GLP-1s affect non-oral birth control like IUDs, implants, patches, or rings, according to the UK's Faculty of Reproductive Healthcare. And yes, the advice applies even to women previously told they were infertile. GLP-1s have been shown to boost fertility by aiding weight loss, reducing inflammation and improving insulin sensitivity — leading some to conceive just months after starting treatment. 4 GLP-1 agonists can increase your fertility, but they can also interfere with pregnancy. Louis-Photo – Can you take GLP-1s while pregnant? Experts say no — at least not yet. There's not enough data to confirm whether GLP-1s are safe during pregnancy. While a some human studies suggests there is no harm in first-trimester use, testing in animals has shown the drugs could increase the risk of miscarriage and birth defects. 4 Scientists are still working to understand whether GLP-1s can negatively impact a developing fetus. Evrymmnt – Another reason to skip GLP-1s while pregnant: they suppress your appetite and can trigger gastrointestinal issues, which may lead to nutrient deficiencies that impact fetal development. The drugs should also be avoided during breastfeeding, since there's not enough research to confirm safety for infants. Trying to conceive? Here's the timeline If you're planning to get pregnant, the MHRA recommended stopping GLP-1s before you start trying to conceive and giving your body time to clear the drugs. For semaglutide users, that means quitting at least two months ahead. If you're on tirzepatide, stop one month before trying. Liraglutide clears the system faster, so you can stop right before you start trying to conceive.
Yahoo
3 hours ago
- Yahoo
Millions more to get test results via NHS app, government says
The NHS app will become the default method of communication for millions more patients in England and save the health service £200m over the next three years, the government has said. More test results, screening invitations and appointment reminders will be sent directly to smartphones as part of a £50m investment in the app, in a move away from traditional communication methods such as letters. It is estimated that at least 50 million letters are sent to patients each year. The Department of Health and Social Care said that people who cannot access app messaging - including elderly patients - will receive text messages and then a letter as a last resort, and NHS phone lines would be freed up. The department says 270 million messages will be sent through the NHS app this financial year - an increase of 70 million on the previous year. Push notifications will provide appointment reminders to patients to try to reduce the risk of no attendance - with around eight million missed appointments in elective care missed in 2023/24. Work is also under way to enable users of the app to add appointments to their phone calendars and request help from their local GP surgeries. Figures show that more than 11 million people in the UK log into the NHS app every month, while almost 20 million are opted in to receive healthcare messages from the app. It is hoped the changes will give patients better access to manage their healthcare journey and make informed decisions about their care. NHS app services, which were launched in December 2018, are now used in 87% of hospitals across England. Health Secretary Wes Streeting said further investment in the app would bring the NHS into the digital age so that being a patient was as "convenient as online banking or ordering a takeaway". He added that moving away from paper communication could free up funding for front line services. Rachel Power, chief executive of the Patient's Association, said the upgrade was a "significant step in modernising how patients receive information". The British Medical Association (BMA) has previously warned that a reliance on apps to the NHS to communicate with patients risked alienating patients who don't have access to digital technology. It followed the government's announcement in January that it planned to allow more patients in England to book treatments and appointments through the app. Last month, NHS England announced millions of patients would be able to get "Amazon-style" tracking updates on their prescriptions through the app, to check if their medicines are ready to collect or have been despatched for delivery. New app trial cuts skin cancer referrals by 50% NHS App upgrade to give patients more choice over treatment Patients to get full access to record on NHS App
