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The Food and Drug Administration has approved changes to the labeling for the popular weight-loss drug Ozempic after acknowledging reports of intestinal blockages following use of the medication.
The FDA approved label updates to include the gastrointestinal disorder ileus, which is a blockage of the intestine, as a possible adverse reaction.
The FDA did not go so far as to affirm a causal link between semaglutide, the active ingredient in Novo Nordisk’s Ozempic, and ileus, however.
“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 states.
According to the FDA, the agency has received 8,571 reports of gastrointestinal disorders after use of semaglutide medications, including Ozempic and Wegovy, which is also manufactured by Novo Nordisk. The Eli Lilly-made diabetes medication Mounjaro also contains semaglutide and warns of ileus on its label.
At least two deaths are associated with reported ileus following use of semaglutide according to data compiled by the FDA.
Ozempic received an additional label change, warning patients who take it in combination with insulin or an insulin secretagogue such as sulfonylurea. of possible adverse reactions.
“OZEMPIC stimulates insulin release in the presence of elevated blood glucose concentrations. Patients receiving OZEMPIC in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia,” the updated label reads.
Per reports, the agency is also monitoring reports of possible gastroparesis, or paralysis of the stomach, which blocks food from reaching the intestine. The Ozempic label already warns the drug may cause a “daly of gastric emptying.”
Novo Nordisk and Eli Lilly are each facing a lawsuit over claims that semagutide cause gastroparesis. Attorneys Paul Pennock and Jonathan Sedgh with the firm Morgan and Morgan have said they are investigating hundreds of reports from clients in connection with the lawsuit.
TMX contributed to this article.