FDA Adds New Side Effect Warning to Ozempic Label
Popular semaglutide injectable Ozempic will now have a warning about intestinal blockage after the Food and Drug Administration accepted manufacturer Novo Nordisk’s proposed changes to the drug’s packaging.
Semaglutide mimics the body’s GLP-1 hormone, which regulates sugars and can decrease appetite. While the drug was originally approved for diabetes patients, its side-effect of weight loss quickly made it a desirable option online. As of Sept. 2023, Ozempic is still considered to be on national shortage by the FDA, which has driven up prices and in some cases, pushed desperate patients to seek out illegal generic versions. Ozempic manufacturer Novo Nordisk has continued to file lawsuits in an attempt to curb the growing market for semaglutide knockoffs in the U.S. but has been unable to stop the desire for the drug.
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The addition now includes Ozempic in the full group of GLP-1 medications that can cause ileus. Prior to this update, the Novo Nordisk produced Wegovy as well as Eli Lilly’s Mounjaro already carried the warning. According to the Mayo Clinic, ileus is another way to describe intestinal obstructions, blockages that can keep food from continuing on its path through the small and large intestine. If left untreated, ileus can cause parts of the intestine to die, leading to major problems or death for patients.
While the reaction is new to Ozempic packaging, gastrointestinal side effects are common for GLP-1 medicines. Earlier this year, CNN reported that at least two Ozempic users experienced stomach paralysis from taking the drug, while a larger majority reported stomach issues like constipation, nausea, and diarrhea. According to the FDA’s Adverse Events Reporting System public dashboard, 33 Ozempic patients this year have reported experiencing ileus after taking the drug. “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 FDA said in its update.
In a statement to Rolling Stone, Novo Nordisk said that patient safety is a top priority, and the updated labeling was in coordination with the FDA to monitor the safety profile of the drug.
“Novo Nordisk stands behind the safety and efficacy of Ozempic and all of our medicines when used consistent with the product labeling and the approved indications,” a spokesperson said. “For Ozempic, the most commonly reported side effects include: nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.”
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