Novo Nordisk Sues Florida Compounding Pharmacies Over Semaglutide Impurities
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As Novo Nordisk, the Danish manufacturer of Ozempic, struggles to meet the global demand for its blockbuster drug, compounding pharmacies have stepped in to address the supply shortage.
But earlier this summer, the FDA warned some pharmacies were using the salt forms of semaglutide, the active ingredient in Ozempic and Wegovy, which had not been properly approved.
In response to ongoing issues, Novo Nordisk filed a lawsuit against a compounding pharmacy and refiled legal proceedings against a second. The lawsuits were prompted by the discovery of impurities in the weight-loss drugs supplied by Wells Pharmacy and Brooksville Pharmaceuticals, both based in Florida, according to Reuters.
Novo Nordisk’s findings revealed impurities in all the tested drugs, some containing as much as 33% impurity from the standard.
“Compounded products do not have the same safety, quality and effectiveness assurances as FDA-approved drugs, and adulterated and misbranded injectable compounded drugs may expose patients to significant health risks,” Jason Brett, a Novo Nordisk executive, said in a statement to Reuters.
Brooksville Pharmacy disputed the allegations and plans to file a motion to dismiss, managing partner Terry Myers told Reuters.
Recent Boxed Warnings and Ongoing Ozempic Lawsuits
The FDA is warning Ozempic users of a potentially deadly illness associated with the popular weight loss and diabetes drug. The illness, called ileus, can result in intestinal blockage requiring surgery or other medical intervention.
In September, the U.S. Food and Drug Administration required Novo Nordisk to add ileus as an adverse reaction in the Postmarketing Experience section of the drug’s prescribing information.
At least 20 people have reported ileus as a serious adverse event to the FDA and two people have died, according to Forbes. The ileus warning is also on other glucagon-like peptide-1 (GLP-1) receptor agonist drugs Mounjaro and Wegovy.
“Ileus is the slowing down of the peristaltic action of the gut that is needed to move food along the GI tract so it can be absorbed,” Dr. Barry Sears, president of the Inflammation Research Foundation, told Drugwatch.
When a patient contracts ileus, it slows down the constant movement of the intestines, which could cause severe pain and complications like blockage or kinking, Sears said.
Since the semaglutide drug skyrocketed in popularity earlier this year, the FDA has received hundreds of reports of gastrointestinal issues linked to the drug.
“Ozempic at high concentrations slows down that movement and this contributes to part of its appetite suppression actions,” Sears said. “In severe cases, Ozempic can cause gut paralysis.”
Semaglutide, the main ingredient in Ozempic, is known to slow digestion, but should not stop it from occurring.
While it’s rare, some people have experienced gut paralysis, formally called gastroparesis, after taking Ozempic and have filed lawsuits. When this occurs, the stomach slows to a near stop and can cause many problems.
Early signs of gastroparesis include abdominal pain, bloating, feeling full after eating a very small amount of food or vomiting undigested food hours after eating.
The Ozempic lawsuits are still in the early stages and lawyers expect more cases to be filed.
