FDA Sends Warning Letter to Ozempic Maker Over Potential Unreported Side Effects
The Food & Drug Administration (FDA) has sent a warning letter to the maker of popular diabetes and weight loss drugs Ozempic and Wegovy. Last week, the FDA accused Novo Nordisk of failing to develop proper procedures for reporting on side effects related to these popular diabetes and weight loss drugs.
In its letter, the agency claimed that Novo Nordisk had failed to report the deaths of three patients who were taking GLP-1 drugs produced by the company. One of these cases involved a patient who committed suicide. The FDA did not say in its letter that the drugs were responsible for these deaths.
The agency said that Novo Nordisk has 15 business days to respond to the letter explaining actions the company will take to prevent similar violations in the future.
More Research Ties Ozempic, Other GLP-1s, to Vision Loss
In addition, more evidence recently emerged tying drugs like Ozempic to a serious side effect that can cause vision loss. A study published this week in the British Journal of Ophthalmology found that people who use Wegovy could be at a significantly heightened risk of permanent vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
This condition, sometimes called an eye stroke, occurs when blood flow to the optic nerve is reduced. It can result in painless, permanent vision loss.
The study determined that people who take Wegovy have nearly five times the risk of developing NAION than those taking Ozempic.
People are now filing GLP-1 lawsuits over claims that they experienced vision loss after taking these drugs. In 2025, the European Medicines Agency determined that NAION was a potential side effect of Ozempic and Wegovy.
Past Studies Connect Ozempic to Serious Vision Condition
This is not the first study to uncover links between drugs like Ozempic and vision loss, as evidence has grown in recent years.
At the annual meeting of the American Academy of Ophthalmology in October, a new study was presented showing that patients who take GLP-1 drugs could be more than 68 times more likely to develop NAION.
Other research in this area dates back to 2024.
Ozempic Blindness Lawsuits Accelerate Following Consolidation
The progress on lawsuits filed by people who say they experienced blindness after using Ozempic or other GLP-1s has picked up in recent months. These lawsuits have been consolidated at both the federal and state levels.
This is a key step used when many more lawsuits are expected to be filed around a similar issue, placing all these cases before one judge for coordinated proceedings. This can lead to streamlined, faster results in litigation.
Lawsuits were grouped together in New Jersey state court in November. New Jersey is the home of Novo Nordisk’s U.S. headquarters. Lawsuits from across the country are expected to be filed there. Lawsuits filed in federal court were similarly consolidated in December.
Thousands of other lawsuits have been filed separately over claims that GLP-1 drugs are tied to serious gastrointestinal issues. Those cases have also been consolidated in federal and state courts.
