Health regulators in Europe will investigate whether Ozempic and other weight-loss drugs cause blindness.
Several studies have linked the injections to a condition that blocks blood flow to the nerves in the eye, 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 cases of Non-arteritic anterior ischemic optic neuropathy (NAION).
Then, earlier this month, two studies conducted in Denmark, where the maker of Ozempic is based, found a similar connection.
That led the Danish government to investigate and initiate a request to the EU. They said the new studies: “Strengthen this suspicion and may contain important new information that needs to be evaluated.”
NAION occurs when blood flow to the nerve that connects the eye to the brain is cut off, disrupting the connection and leaving someone blind.
It is unclear how semaglutide may increase these risks, because it primarily works by mimicking hormones that control hunger.
Ozempic is approved only 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 medication works to mimic hormones that control hunger and digestion rates.
Since its approval and mass circulation, patients have reported a number of unexpected side effects related to various weight loss medications.
Black box warnings for Ozempic include that it may increase the risk of developing thyroid tumors. The label also warns about the risk of developing stomach paralysis which can cause nausea, vomiting and malnutrition.
Other people have reported developing problems with suicidal thoughts, sexual dysfunction, and hair loss as a result of the drug.
About 6 percent of Americans currently use some form of the drug, representing more than 15 million people.
NAION It can occur naturally, due to things like old age, high blood pressure or blood vessel problems, or due to habits like smoking. It affects about 6,000 Americans each year, according to University of California, Davis Health.
Doctors disagree about why this happens, but suggest it could be that damage to blood vessels, or clots within these pathways, can lead to loss of blood flow to this crucial region.
Two separate investigations in the University of Southern Denmark found that people who had been taking semaglutide had a higher risk of developing NAION.
The first study, which looked at 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 using Ozempic with diabetics using other medications to control their condition, is undergoing the peer review process.
It found that: “Semaglutide is associated with an increased risk of NAION, but also that the absolute excess risk is low.”
Although neither has been formally published, Danish scientists thought their preliminary findings were compelling enough to notify health officials.
The Danish Medicines Agency, which had already been tracking NAION cases linked to the injections, asked the EU’s Pharmacovigilance Risk Assessment Committee to investigate the link.
It is not clear whether the EU’s independent medicines regulator has agreed to start this investigation.
The Danish findings build on highly successful studies in the United States that were published this summer.
In the Harvard study, which was published in the Journal of Ophthalmology of the American Medical AssociationThe researchers analyzed data from more than 16,000 patients who were using semaglutide, the active ingredient in Ozempic and Wegovy.
Over three years, 8.9 percent of people with diabetes taking the drug developed NAION, compared with 1.8 percent of people taking other medications.
Real Housewives of New Jersey star Dolores Catania admitted to using Ozempic to lose weight in the six weeks leading up to the RHNJ reunion.
Although this trend was clear in the study, doctors cautioned that it cannot be concluded from their findings that Ozempic caused vision loss.
Study author Joseph Rizzo, professor of ophthalmology at Harvard Medical School, said: “Our findings should be considered significant but provisional, as future studies are needed to examine these questions in a much larger and more diverse population.”
Dr. Rizzo added, “However, it is important to note that the increased risk is related to a disorder that is relatively rare.”
Likewise, NovoNordisk, which makes both Ozempic and Wegovy, issued statements saying this link is unproven and rare.
In response to this move by the Danish authorities, a NovoNordisk spokesperson said: “After a thorough evaluation of the University of Southern Denmark studies and Novo Nordisk’s internal security assessment, Novo Nordisk is of the opinion that the benefit profile- semaglutide risk remains unchanged’
It is unclear whether US regulators are investigating something similar. Dailymail.com has contacted the FDA for comment on whether they will also be investigating.