Sept. 28, 2023 – Following greater than a dozen reviews of intestinal blockages amongst folks utilizing the diabetes drug Ozempic, the FDA introduced that the doubtless life-threatening situation can be listed on the drug’s label.
The medical time period for intestinal blockage is “ileus,” and 18 circumstances of it in folks taking Ozempic have been reported to the FDA.
The FDA has acquired greater than 8,500 reviews of gastrointestinal points amongst folks taking medicines like Ozempic and Wegovy, the latter of which is authorized for weight reduction. Ileus is talked about in 33 circumstances, together with two deaths, of individuals taking medicine containing semaglutide, which is the energetic ingredient in Ozempic, Wegovy, and one other broadly used weight reduction drug referred to as Mounjaro.
Semaglutide works by mimicking a hormone referred to as glucagon-like peptide-1 (GLP-1) that targets mind areas that regulate urge for food and meals consumption. The labels for Mounjaro, Ozempic, and Wegovy already point out that delayed abdomen emptying can happen. Important weight reduction is related to taking semaglutide, usually within the vary of 15% of physique weight.
The FDA stopped in need of saying there’s a direct hyperlink between Ozempic and intestinal blockages.
“As a result of these reactions are reported voluntarily from a inhabitants of unsure dimension, it isn’t at all times attainable to reliably estimate their frequency or set up a causal relationship to drug publicity,” the FDA mentioned in its approval of the label replace.
The identical warning for the danger of intestinal blockages is already listed on the labels for Mounjaro and Wegovy.
The label change comes after a Louisiana lady filed a lawsuit in August that claims she was “severely injured” after utilizing Mounjaro and Ozempic and that the pharmaceutical firms did not disclose the medicine’ threat of inflicting vomiting and diarrhea because of irritation of the abdomen lining, in addition to the danger of abdomen paralysis (often called gastroparesis.)