Ozempic Manufacturer Sues Florida Pharmacies Over ‘Impure’ Weight Loss Drug Copies
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Ozempic manufacturer Novo Nordisk is taking legal action against Florida pharmacies for allegedly selling impure semaglutide compounds. This development follows FDA warnings about unapproved semaglutide use and highlights issues surrounding patient safety and pharmaceutical regulation.
Novo Nordisk holds the exclusive patent for semaglutide, the active ingredient in its popular Type 2 diabetes drug, and says it doesn’t distribute the ingredient to other entities. This exclusivity has led to uncertainties regarding the products that compound pharmacies market to consumers. Novo Nordisk examined products offered as semaglutide by two pharmacies in Florida, Wells Pharmacy and Brooksville Pharmaceuticals.
According to their findings and subsequent legal claims, a sample from Wells Pharmacy contained 33% of “unidentified impurities.” Meanwhile, the sample from Brooksville Pharmaceuticals showed a lower amount of the active ingredient than specified on the product label and also contained impurities.
With health care professionals already divided over the use of compounded drugs, the legal outcomes of these new lawsuits could shift market dynamics away from the compounding option popular with patients using semaglutide off-label for weight loss.
Recent Semaglutide Warnings
In September, the FDA warned Ozempic users of a potentially deadly illness associated with the popular weight loss and diabetes drug.
Ileus, marked by severe pain and potential intestinal blockage, have been reported many times to the U.S. Food and Drug Administration’s Adverse Event Reporting System.
“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 in Peabody, Mass., told Consumer Notice.
At least 20 people have reported ileus while using Ozempic as a serious adverse event to the FDA, with two reported deaths, according to Forbes. The ileus warning is also applicable to other glucagon-like peptide-1 (GLP-1) receptor agonist drugs Wegovy and Mounjaro.
Following the warnings, the FDA required Novo Nordisk to add ileus as an adverse reaction in the Postmarketing Experience section of Ozempic’s prescribing information.
Ozempic Lawsuits Filed Over Gut Paralysis
The surge in popularity of semaglutide medicines is accompanied by a rise in other serious gastrointestinal issues linked to the prescription medicine.
“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.”
Earlier this year, Wegovy and Ozempic users began reporting gastroparesis, which occurs when the stomach slows to a stop and becomes paralyzed. Early signs of gastroparesis include abdominal pain and bloating. Severe cyclical vomiting has also been reported.
People who developed gastroparesis after taking Ozempic can consult an attorney about filing a lawsuit and seeking compensation. New Ozempic lawsuits are currently being filed and lawyers are still actively taking clients.