EU Launches Investigation Into Ozempic Vision Loss Problems

Danish health care experts have asked the European Union (EU) to launch an investigation into the potential side effects of Ozempic and Wegovy, which recent studies have suggested could increase the risk of severe vision loss problems or blindness.

Ozempic and Wegovy are glucagon-like peptide-1 receptor agonists (GLP-1 RAs), which both contain the same active ingredient semaglutide. Ozempic was originally approved in 2017 for the treatment of type 2 diabetes. However, when Novo Nordisk discovered that it also carried significant weight loss effects, the drug maker introduced the higher dose version, Wegovy, which is approved as a diet drug.

Although the medications have been widely used over the past few years, a number of potential side effects have emerged, including a risk of severe gastrointestinal problems such as gastroparesis, or stomach paralysis, ileus and intestinal blockages.

Recent studies have also uncovered concerns about a potential link between Ozempic and vision loss, finding that users face an increased risk of developing a rare eye condition, known as non-arteritic anterior ischemic optic neuropathy (NAION), where the optic nerve suffers from insufficient blood flow.

Thousands of former users are now pursuing Ozempic lawsuits and Wegovy lawsuits in the United States, each raising similar allegations that the manufacturers placed a desire for increased profits above consumer safety by failing to research and disclose side effects of semaglutide users may experience.

Concerns about Ozempic vision loss problems first emerged in early July 2024, when a study by Harvard researchers found that patients using semaglutide may face a seven fold increased risk for experiencing sudden vision changes, blurred sight, blindness or other symptoms linked to NAION.

Those findings were then confirmed in a study published in medRxiv on December 11, leading the Danish Medicines Agency to issue a press release days later, announcing that it is officially requesting an investigation into Ozempic NAION risks

The request has been sent to the European Pharmacovigilance Risk Assessment Committee (PRAC), indicating that Danish health experts have received a total of 19 reports of NAION diagnosed among users of Ozempic or Wegovy since July 2024.

“Up to now, the data basis of the adverse reaction reports and of earlier studies on NAION was not strong enough to point to a signal of a possible link between the medicine and the symptoms,” Danish health experts indicated. “However, the results from the new… studies reinforce this suspicion and may hold new important information that should be assessed by the European Pharmacovigilance Risk Assessment Committee, PRAC, to find out if semaglutide and NAION could be linked.”

December 2024 Ozempic Lawsuit Update

The increasing concerns about vision problems from Ozempic and Wegovy come as lawsuits over gastrointestinal risks associated with the entire class of medications continue to move forward in the federal court system.

Given common questions of fact and law raised in gastroparesis lawsuits filed on behalf of users of Ozempic, Wegovy, Mounjaro, Zepbound, Victoza and Trulicity, a federal Multidistrict Litigation (MDL) has been established before U.S. District Judge Karen S. Marston in the Eastern District of Pennsylvania.

As part of the coordinated management of the pretrial proceedings, Judge Marston has directed the parties to focus in the early stages of the litigation on “cross cutting” issues, which will impact a large number of claims. This includes an evaluation of the general causation evidence about the link between Ozempic and gastroparesis, ileus and other injuries, as well as questions about whether the claims are preempted by federal law and whether plaintiffs will be required to provide specific testing evidence to establish they suffered an injury.

Following the resolution of those issues, Judge Marston is expected to direct the parties to select representative lawsuits for early bellwether test trials, to help gauge how juries will respond to evidence and expert testimony likely to be repeated throughout the litigation.

While the outcomes of such early test trials are not binding on other claims, they could help potentially facilitate an Ozempic settlement agreement that would avoid the need for each individual case to be set for trial in the future.