The U.S. Food and Drug Administration has updated Ozempic’s label to recognize complaints of intestinal obstruction in some people who have taken the drug.
The drug semaglutide is designed for people with type 2 diabetes, but has been widely used as a weight loss remedy.
Ozempic works by mimicking a natural hormone, GLP-1, which slows the passage of food through the stomach and intestines, making people feel fuller longer.
However, problems begin to arise if the medication slows the intestines too much, causing some to develop ileus, when the intestines’ ability to contract slows to the point of prohibiting the body’s ability to properly remove waste, causing which causes intestinal obstruction.
“The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient in OZEMPIC. Because these reactions are reported voluntarily in a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship with drug exposure,” the FDA noted on its website that now officially lists ileus. as a possible adverse reaction.
Labels for similar medications, including Wegovy and Mounjaro, already acknowledge reports of the condition. Ileus is just one of a long list of unwanted side effects that users have reported from this category of medications.
Last week, the U.S. Food and Drug Administration updated Ozempic’s label to acknowledge complaints of intestinal obstruction in some people who have taken the drug. REUTERSOzempic works by mimicking a natural hormone, GLP-1, which slows the passage of food through the stomach and intestines, making people feel fuller longer. NurPhoto via Getty Images
The FDA update comes as the federal agency received more than 6,100 reports of a variety of gastrointestinal disorders from Ozempic users, including gastroparesis, or “stomach paralysis.”
The makers of Ozempic and Mounjaro are being sued over claims that the companies “downplayed the severity of gastrointestinal events” resulting from use of the drugs.
In response to the lawsuit, a Novo Nordisk representative told The Post: “Semaglutide has been extensively examined in robust clinical development programs, large real-world evidence studies and has a total of more than 9.5 million patients. year of exhibition”.
They noted that “gastrointestinal (GI) events are well-known side effects of the GLP-1 class.”
The FDA update comes as the federal agency received more than 6,100 reports of a variety of gastrointestinal disorders from Ozempic users. Getty Images/iStockphoto
“Patient safety is Lilly’s top priority and we actively participate in monitoring, evaluating and submitting safety information for all of our medications,” Eli Lily and Co. told The Post in a statement about the lawsuit.
The weight-loss drug craze began so quickly in recent years that the FDA announced shortages as the drug disappeared from shelves.
But some experts have warned that Ozempic and other similar drugs have not been available long enough to study long-term effects, including possible suicide, and some are likely misusing them as a quick way to lose a few pounds.
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Source: vtt.edu.vn