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FDA tags Wegovy with new warning for gastrointestinal reactions

From The Dallas Morning News

FDA tags Wegovy with new warning for gastrointestinal reactions

The weight loss drug Wegovy has been associated with increased gastrointestinal issues, which can sometimes be severe, according to an updated warning label from the U.S. Food and Drug Administration.

The FDA added the warning to the wildly popular GLP-1 treatment's label at the end of November. Participants in clinical trials of the drug were more likely to report "severe gastrointestinal adverse reactions," the updated label says.

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The FDA warns that people with severe gastroparesis -- a condition in which the stomach doesn't move food along quickly enough, which can cause nausea and pain -- should not take the weight loss drug.

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Milder gastrointestinal reactions, such as nausea and constipation, are the most common side effects of GLP-1 receptor agonists such as Wegovy.

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However, the new warning label references more severe side effects. The label now advises patients to tell their doctor if they're having severe stomach issues or if their stomach issues don't resolve.

The FDA did not update the warning labels of other GLP-1s including Ozempic, Rybelsus, Saxenda, Victoza, Mounjaro and Zepbound. At least one, Zepbound, already included a warning label for people with severe gastroparesis and severe gastrointestinal disease.

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GLP-1s can be prescribed for weight loss and for diabetes treatment, as well as some other conditions. About 12% of American adults report they've taken one at some point, according to a May 2024 poll from KFF Health News.

The latest Wegovy update comes on the heels of another recently added warning. On Nov. 1, the FDA warned that people taking a GLP-1 may have a higher risk of inhaling gastric contents into their lungs while under anesthesia.

That's because GLP-1s -- including Wegovy, Ozempic and others -- slow stomach emptying, causing food or gastric juices to remain in the stomach for longer. Doctors told The Dallas Morning News earlier this month that they have long known about the increased risk anesthesia can pose to patients on GLP-1s.

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More severe side effects such as gastroparesis had also been fairly well documented before the FDA's recent warning update to Wegovy. A 2023 study found that GLP-1s were associated with an increased risk of gastroparesis. Additional studies presented in 2024 found a similar link.

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