FDA updates Ozempic label with potential blocked intestines aspect impact, additionally reported with Wegovy and Mounjaro
The label for the diabetes drug Ozempic — which has change into popular for weight loss — now acknowledges reviews of blocked intestines following use of the medication. The change comes after the Meals and Drug Administration greenlighted a series of updates from drugmaker Novo Nordisk for its product.
Ozempic now joins different merchandise on this booming class of so-called GLP-1 agonist medicines which acknowledge elevated reviews of what doctos name ileusor a blockage within the intestines.
Weight reduction drug Wegswhich can also be an injection of semaglutide manufactured by Novo Nordisk, acknowledges reviews of ileus on its label as nicely, as does Mounjaroa diabetes remedy from Eli Lilly.
Nevertheless, the FDA stopped wanting straight blaming the doubtless life-threatening situation on 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 reads.
The FDA has obtained 8,571 reviews of gastrointestinal issues after use of semaglutide medicines, which incorporates each Ozempic and Wegovy, in accordance with data printed by the regulator by way of June 30.
Ileus is particularly talked about as a response in 33 instances listed on the FDA’s dashboard of individuals taking semaglutide, together with two deaths.
Each Novo Nordisk and Eli Lilly are additionally going through a lawsuit over claims that the medicines could cause the same situation referred to as gastroparesis, or paralysis of the stomachwhich stops meals from reaching the small gut regardless of there being no blockage.
“Although there is some overlap in the terms, ileus and gastroparesis, they are not synonymous,” FDA spokesperson Chanapa Tantibanchachai mentioned in a press release.
Tantibanchachai famous that labels for Ozempic and related medicines already point out that they trigger “delay of gastric emptying.” However the regulator is continuous to observe “reports of gastroparesis and other related terms” in real-world use of the drug.
“If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data,” she mentioned.
A spokesperson for Novo Nordisk didn’t instantly reply to a request for remark.
