Fda Adds Warning of Intestinal Blockages to Ozempic Label

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Sept. 28, 2023 – Subsequent additional than a dozen experiences of intestinal blockages amongst men and women making use of the diabetic issues drug Ozempic, the Food and drug administration introduced that the probably life-threatening affliction will be outlined on the drug’s label.

The professional medical expression for intestinal blockage is “ileus,” and 18 scenarios of it in persons having Ozempic have been described to the Fda. 

The Fda has received more than 8,500 experiences of gastrointestinal difficulties between men and women taking remedies like Ozempic and Wegovy, the latter of which is permitted for fat decline. Ileus is stated in 33 instances, together with two deaths, of people today taking medication containing semaglutide, which is the lively ingredient in Ozempic, Wegovy, and a different extensively utilised excess weight decline drug called Mounjaro. 

Semaglutide is effective by mimicking a hormone named glucagon-like peptide-1 (GLP-1) that targets brain locations that control hunger and food ingestion. The labels for Mounjaro, Ozempic, and Wegovy presently point out that delayed abdomen emptying can come about. Important body weight reduction is affiliated with using semaglutide, generally in the selection of 15% of overall body weight.

The Food and drug administration stopped short of declaring there is a direct connection in between Ozempic and intestinal blockages.

“Because these reactions are described voluntarily from a populace of unsure dimension, it is not usually probable to reliably estimate their frequency or build a causal romantic relationship to drug exposure,” the Fda said in its acceptance of the label update.

The identical warning for the risk of intestinal blockages is currently outlined on the labels for Mounjaro and Wegovy.

The label adjust will come soon after a Louisiana woman filed a lawsuit in August that promises she was “severely injured” soon after using Mounjaro and Ozempic and that the pharmaceutical firms failed to disclose the drugs’ possibility of triggering vomiting and diarrhea owing to irritation of the belly lining, as effectively as the threat of belly paralysis (recognised as gastroparesis.)

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