The U.S. Food and Drug Administration has updated the Ozempic label to acknowledge complaints of blocked intestines in some people who have taken the medication.
The semaglutide drug is designed for people with Type 2 diabetes but has become widely used as a weight-loss remedy.
Ozempic works by mimicking a natural hormone, GLP-1, which slows down the passage of food through the stomach and intestines, making people feel full for longer.
However, issues start 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 intestinal blockage.
“The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of OZEMPIC. 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 FDA noted on their website now officially listing ileus as a possible adverse reaction.
The labels of similar medications, including Wegovy and Mounjaro, already acknowledge reports of the condition. Ileus is just one of a long list of unwanted side effects users have reported from this category of medications.
The FDA update comes as the federal agency has received more than 6,100 reports of an array of gastrointestinal disorders from Ozempic users, including gastroparesis or “stomach paralysis.”
The manufacturers of Ozempic and Mounjaro are being sued over claims that the companies “downplayed the severity of the gastrointestinal events” from using the drugs.
In response to the lawsuit, a representative for Novo Nordisk told The Post, “Semaglutide has been extensively examined in robust clinical development programs, large real-world evidence studies and has cumulatively over 9.5 million patient years of exposure.”
They noted that “gastrointestinal (GI) events are well-known side effects of the GLP-1 class.”
“Patient safety is Lilly’s top priority, and we actively engage in monitoring, evaluating and reporting safety information for all our medicines,” Eli Lily and Co. told The Post in a statement regarding the lawsuit.
The weight-loss drug craze kicked off so quickly in the last few years that the FDA announced shortages as the medication flew off the shelves.
But some experts have warned that Ozempic and other similar medications have not been available long enough to study the long-term effects — including potentially leading to suicide — and are likely being misused by some as a quick way to shed a few pounds.