Health regulators in Europe will investigate whether Ozempic and other weight loss drugs cause blindness.
Several studies have now linked the injections to a condition that blocks blood flow to the optic nerves, causing vision loss.
Doctors at Harvard began investigating NovoNordisk’s blockbuster drug, which is officially approved for the treatment of diabetes, in 2023 after three patients taking the drug were diagnosed with the condition within a week.
Their findings, published in July, warned that Ozempic may be linked to a two-fold increase in the number of cases of cancer nonarterial anterior ischemic optic neuropathy (NAION).
Earlier this month, two studies from Denmark, where Ozempic’s maker is based, found a similar link.
This prompted the Danish government to investigate and submit a request to the EU. They said the new studies: ‘Reinforce this suspicion and may provide new important information that needs to be assessed.’
NAION occurs when blood flow is cut off to the nerve that connects the eye to the brain, causing the connection to be severed and a person to become blind.
It’s unclear how semaglutide might increase these risks, because it works mainly by imitating hormones that control hunger.
Ozempic is only approved as a treatment for diabetes, but some patients are prescribed it off-label for weight loss. Wegovy, which has the same active ingredient in different doses, is approved for weight loss. The drug mimics hormones that control hunger and digestion
Since their approval and mass distribution, patients have reported a number of unexpected side effects associated with the various weight loss medications.
Black box warnings for the Ozempic include that it may increase the risk of developing thyroid tumors. The label also warns of the risk of gastric paralysis, which can lead to nausea, vomiting and malnutrition.
Other individuals have reported developing problems with suicidal thoughts, sexual dysfunction, and hair loss as a result of the drug.
About 6 percent of Americans currently using some form of the drug represents more than 15 million people.
NAION can occur naturally, due to things like old age, high blood pressure or blood vessel problems, or due to habits like smoking. It is estimated that approximately 6,000 Americans are affected each year UC Davis Health.
Doctors don’t agree why this happens, but suggest that damage to the blood vessels, or clots in these pathways, can lead to loss of blood supply to this crucial area.
Two separate studies at the University of Southern Denmark found that people who had taken semaglutide had an increased risk of developing NAION.
The first study, which examined 424,152 Danes with diabetes and found that Ozempic doubles the risk of NAION, has been accepted for publication in a journal.
The second study, which compared diabetics taking Ozempic with diabetics taking other medications to control their condition, is currently undergoing a peer review process.
It was found that: ‘Semaglutide is associated with an increased risk of NAION, but also that the additional absolute risk is low.’
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Although neither has been formally published, the Danish scientists found their preliminary findings compelling enough to notify health officials.
The Danish Medicines Agency, which was already monitoring NAION cases linked to the shots, asked the EU Pharmacovigilance Risk Assessment Committee to investigate the link.
It is unclear whether the EU’s independent medicines regulator has agreed to launch this investigation.
The Danish findings build on blockbuster studies conducted in America and published this summer.
In the Harvard study, published in the Journal of the American Medical Association Opthamologythe researchers looked at data from more than 16,000 patients who used semaglutide, the active ingredient in Ozempic and Wegovy.
Over three years, 8.9 percent of people with diabetes who took the drug developed NAION, compared with 1.8 percent of people who took other medications.
Real Housewives of New Jersey star Dolores Catania admitted she used Ozempic to lose weight during the six weeks leading up to the RHNJ reunion
Although this trend was evident in the study, the doctors cautioned that their findings cannot conclude that Ozempic caused the vision loss.
Study author Joseph Rizzo, professor of ophthalmology at Harvard Medical School, said: ‘Our findings should be viewed as significant but preliminary, because future studies are needed to investigate these questions in a much larger and more diverse population.’
Dr. Rizzo added: ‘However, it is important to realize that the increased risk is associated with a condition that is relatively uncommon.’
Similarly, NovoNordisk, which produces both Ozempic and Wegovy, has released statements claiming that this link is unproven and rare.
Commenting on this move by the Danish authorities, a NovoNordisk spokesperson said: ‘Following a thorough review of the University of Southern Denmark studies and Novo Nordisk’s internal safety assessment, Novo Nordisk believes that the benefit-risk profile of semaglutide remains is always present. unchanged’
It is not clear whether US regulators are looking at a similar solution. Dailymail.com has reached out to the FDA for comment on whether they will also investigate.