FDA Adds Warning of Intestinal Blockages to Ozempic Label
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Sept. 28, 2023 – Following extra than a dozen reviews of intestinal blockages among people the exercise of the diabetes drug Ozempic, the FDA announced that the per chance lifestyles-threatening condition shall be listed on the drug’s label.
The medical term for intestinal blockage is “ileus,” and 18 cases of it in people taking Ozempic comprise been reported to the FDA.
The FDA has obtained extra than 8,500 reviews of gastrointestinal considerations among people taking medicines relish Ozempic and Wegovy, the latter of which is authorized for weight loss. Ileus is talked about in 33 cases, including two deaths, of people taking medication containing semaglutide, which is the active ingredient in Ozempic, Wegovy, and each other widely historical weight loss drug known as Mounjaro.
Semaglutide works by mimicking a hormone known as glucagon-relish peptide-1 (GLP-1) that targets brain areas that retain watch over appetite and meals consumption. The labels for Mounjaro, Ozempic, and Wegovy already level out that delayed belly emptying can occur. Predominant weight loss is associated with taking semaglutide, in general in the vary of 15% of body weight.
The FDA stopped wanting announcing there is an instantaneous link between Ozempic and intestinal blockages.
“Because these reactions are reported voluntarily from a inhabitants of dangerous size, it’s miles no longer continually possible to reliably estimate their frequency or put a causal relationship to drug publicity,” the FDA talked about in its approval of the label change.
The equivalent warning for the danger of intestinal blockages is already listed on the labels for Mounjaro and Wegovy.
The label switch comes after a Louisiana lady filed a lawsuit in August that claims she turn out to be “severely injured” after the exercise of Mounjaro and Ozempic and that the pharmaceutical corporations didn’t squawk the medication’ possibility of causing vomiting and diarrhea due to the inflammation of the belly lining, as nicely as the danger of belly paralysis (identified as gastroparesis.)
