The U.S. Meals and Drug Administration (FDA) up to date the label for Ozempic, a sort 2 diabetes drug that’s typically used for weight reduction, to now word the potential aspect impact of intestinal blockage.
In a sequence of labeling modifications for Ozempic, the FDA stated the remedy will now embody a warning of elevated reviews of ileus, or the blockage of intestinal contents, based on the Nationwide Institute of Well being.
Whereas the FDA acknowledged reviews of opposed reactions from semaglutide, an energetic ingredient of Ozempic, the regulator didn’t particularly cite Ozempic or its producer, Novo Nordisk, as the reason for these reviews.
“As a result of these reactions are reported voluntarily from a inhabitants of unsure measurement, it’s not at all times attainable to reliably estimate their frequency or set up an informal relationship to drug publicity,” the FDA wrote in final week’s replace.
Weight reduction drug Wegovy, which is made by the identical producer of Ozempic, additionally has a warning on reviews of ileus on its label.
The change comes lower than two months after a Louisiana girl introduced a lawsuit towards Novo Nordisk and Eli Lily, which manufactures the favored weight reduction drug Mounjaro, alleging the drug makers didn’t warn sufferers concerning the danger of extreme gastrointestinal issues.
The lawsuit, filed in August, claims the producers “downplayed the severity of the gastrointestinal occasions” prompted by their drugs, together with gastroparesis or abdomen paralysis, and gastroenteritis or abdomen irritation.
Each Ozempic and Mounjaro have been created to handle blood sugar ranges in adults with Kind 2 diabetes, however have gained recognition for his or her off-label use for weight reduction.
The Hill has reached out to the FDA and Novo Nordisk for remark.
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