May 14, 2026

Comparing European vs. American GLP-1 Labels

Glucagon-like peptide-1 (GLP-1) receptor agonists have quickly become some of the most widely prescribed medications for managing diabetes and weight concerns. This includes semaglutide medications such as Ozempic®, Rybelsus® and Wegovy®. As GLP-1 popularity has grown, concerns about safety have also increased. Users are now wondering if they are being adequately warned about the potential risks of taking GLP-1 medications.

One growing concern is how these drugs are labeled in Europe versus in the United States. These differences may end up being the foundation of a relevant legal claim against GLP-1 manufacturers.

Who decides what goes on GLP-1 warning labels?

In the European Union (EU or Europe), the European Medicines Agency (EMA) handles warning labels on drugs, while the Food and Drug Administration (FDA) handles labels in the United States. Both of these organizations were designed to ensure compliance with certain standards in medicine and protect those who take these medications.

However, it’s important to note that the EMA only manages medicine and medical devices, while the FDA regulates food, drugs, cosmetics, biologics and medical devices.

Pharmaceutical ads banned in Europe

One main difference between Europe and the U.S. is the approach to promoting pharmaceutical drugs. In the United States, advertising prescription medications is legal, while it is not in the EU. In the United States, advertisements for GLP-1 drugs and various other medications are often shown on TV to the general public. This influences how people see certain drugs and may even entice them to ask their doctors about learning more. This may also inform how warning labels are structured and presented to potential consumers.

GLP-1 drug labeling differences between Europe and America

Both agencies list some of the same GLP-1 side effects: blindness, gastrointestinal issues and acute pancreatitis. How and why they are shown on the GLP-1 labels is where the differences between the EU and the United States come into play.

The European label tends to be more precautionary about including side effects on warning labels, often adding the medical condition before it has been fully evaluated or scientifically studied. On the other hand, the FDA is more hesitant to add certain side effects to a warning label before reviewing all relevant clinical evidence.

This type of different approach is the reason for certain language or side effect inclusion or exclusion on EU versus U.S. drug warning labels.

NAION

A prime example of this is the inclusion of NAION on the EU Ozempic warning label. The warning reads:

“Data from epidemiological studies may indicate an increased risk of non-arteritic anterior ischaemic optic neuropathy (NAION) during treatment with semaglutide. There is no identified time interval for when NAION may develop following treatment start. Patients reporting a sudden loss of vision (including partial loss) should be urgently referred for ophthalmological examination and treatment with semaglutide should be discontinued if NAION is confirmed.”

The U.S. label for Ozempic doesn’t mention NAION specifically. It only mentions changes in vision under the side effects section of the label. This warning reads: “changes in vision. Tell your healthcare provider if you have changes in vision during treatment with OZEMPIC®.”

Vision loss and blindness are still being reported by Ozempic users who have suffered from these side effects.

Gastrointestinal issues

The EU Ozempic label includes a more in-depth warning about possible gastrointestinal effects. This warning reads: “Use of GLP‑1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function.”

The U.S. Ozempic warning label also has a warning regarding gastrointestinal adverse reactions. But it doesn’t provide as much context as the EU warning does, especially as it relates to renal function. It reads: “Use of OZEMPIC® has been associated with gastrointestinal adverse reactions, sometimes severe. In OZEMPIC® clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving OZEMPIC® (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. OZEMPIC® is not recommended in patients with severe gastroparesis.”

Gastroparesis lawsuits continue to dominate Ozempic litigation from users who have experienced a variety of serious gastrointestinal issues after taking the drug.

Diabetic ketoacidosis

The European Ozempic label provides a general warning on taking semaglutide if the GLP-1 user has type 1 diabetes mellitus or to treat diabetic ketoacidosis. It reads: “Semaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Semaglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported in insulin-dependent patients who had rapid discontinuation or dose reduction of insulin when treatment with a GLP-1 receptor agonist is started.”

The Ozempic label in the United States includes a diabetic ketoacidosis mention, but only under the “Pregnancy” section. This warning reads: “Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.”

GLP-1 labeling comparison: EU vs U.S.

Side effect/warning	European Ozempic Label	U.S. Ozempic Label
NAION	Yes	No, just vision loss
Gastrointestinal issues	Yes	Yes, but broad
Diabetic Ketoacidosis	Yes	Yes, but only mentioned under "Pregnancy

Why warning labels matter

Warning labels are essential in pharmaceutical litigation as they help define which risks a manufacturer chooses to disclose or not disclose. Drug makers in both Europe and the U.S. have a duty to warn users and healthcare providers about any and all known risks associated with a drug. When a warning label doesn’t include a certain side effect or minimizes its risk, patients can’t make fully informed decisions about the medicines they take. If they suffer from these unlisted side effects, victims may be able to allege a failure to warn or negligence claim in a lawsuit.

Unlisted medical conditions, such as NAION and the broadly mentioned gastrointestinal issues, are now the basis of two growing MDLs in the U.S. for people impacted by these GLP-1 side effects. If you think you’ve experienced severe side effects that weren’t listed or properly explained on the GLP-1 warning label, contact an attorney to discuss your specific situation and help determine whether you have a relevant claim.

Our medical drug litigation experience

Motley Rice’s medical drug attorneys are representing individuals in lawsuits against manufacturers Eli Lilly and Novo Nordisk over their diabetes and weight loss drugs. We represent clients who have been harmed and are alleging serious, unlisted side effects from using these GLP-1 drugs. Our attorneys have filed cases for individuals harmed by GLP-1 RA drugs in both state and federal courts.

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death. Ozempic, Rybelsus and Wegovy remain approved by the U.S. Food and Drug Administration.

Sources