FDA updates Ozempics label to address some users reports of

FDA updates Ozempic’s label to address some users’ reports of blocked intestines

David J. Phillip/AP

The diabetes drug Ozempic and its sister drug Wegovy, which is approved for weight loss, have skyrocketed in popularity recently.


The U.S. Food and Drug Administration has updated the label of the diabetes drug Ozempic to address reports of intestinal blockages in some people taking the drug.

Ozempic and its sister drug Wegovy, approved for weight loss, have skyrocketed in popularity recently. They use a drug called semaglutide, which belongs to a family of drugs called GLP-1 agonists, and mimics a hormone that the body naturally produces to slow the passage of food through the stomach, causing people to feel sick feel full longer.

Drugmaker Novo Nordisk, which makes Ozempic and a similar drug, Wegovy, said in a statement to CNN that patient safety is a top priority and the company is working closely with the FDA “to continually monitor the safety profile” of its drugs.

“Novo Nordisk stands behind the safety and effectiveness of Ozempic® and all of our medicines when used in accordance with product labeling and approved indications,” the company said.

The labels of Wegovy and a diabetes drug called Mounjaro confirm reports of a condition called ileus, or intestinal blockage, in some people who use them. Ozempic’s label has been updated to say the same.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure,” the label reads.

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Some people using Ozempic and Wegovy have also reported developing a condition called gastroparesis, or stomach paralysis. These cases are considered rare, experts say, and may not be a direct result of the drugs themselves. Drug maker Novo Nordisk told CNN in July in response to these claims that GLP-1 agonists have been widely studied and used for years.

“Gastrointestinal (GI) events are known adverse events of the GLP-1 class,” Novo said in a statement. “With semaglutide, most gastrointestinal side effects are mild to moderate in severity and short-lived. GLP-1 is known to delay gastric emptying, as noted on the package insert for each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects.”

A Louisiana woman is suing Novo Nordisk and Eli Lilly over alleged “serious gastrointestinal illnesses” she developed as a result of taking Ozempic and Mounjaro, which resulted in serious injuries.

CNN’s Meg Tirrell contributed to this report.