FDA updates Ozempic label to mention intestinal blockage side effect

The label for Novo Nordisk's weight loss drug Ozempic now acknowledges some users' reports of ileus, or intestinal blockage. 

In its update, however, the FDA said it's difficult to confirm a causal relationship between the side effect and the drug. 

"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 says. 

Wegovy and Mounjaro, also GLP-1 agonist medications, already acknowledge reports of ileus on their labels. Novo Nordisk is the maker of both Ozempic and Wegovy, which both use an injection of semaglutide. 

In a statement to CNN, Novo Nordisk said, "Gastrointestinal events are well-known side effects of the GLP-1 class," adding, "For semaglutide, the majority of GI side effects are mild to moderate in severity and of short duration. GLP-1's are known to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea and vomiting are listed as side effects."

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars