Novo Nordisk has initiated legal action against two compounding pharmacies in Florida, alleging the sale of impure and “potentially unsafe” drugs falsely claiming to contain semaglutide, the active ingredient in Novo Nordisk’s weight loss treatment Wegovy and diabetes medication Ozempic. The Danish drugmaker, the sole patent holder of semaglutide, does not supply the ingredient to external entities, raising concerns about what is being sold by compounding pharmacies.
Novo Nordisk found that products tested from Wells Pharmacy Network and Brooksville Pharmaceuticals were impure, containing unknown and unauthorized substances beyond semaglutide, with one product showing 33% unknown impurities. The impurities pose potential safety risks to consumers, including “possibly serious and life-threatening reactions,” according to Novo Nordisk’s lawsuits. The company is not seeking monetary damages but aims to prevent the pharmacies from selling their products.
Novo Nordisk has filed a total of 12 legal actions against compounding pharmacies, medical spas, and weight loss clinics for allegedly selling duplicates of Wegovy and Ozempic, securing preliminary injunctions in six cases. Rival Eli Lilly has taken similar action against businesses selling imitations of its diabetes drug Mounjaro.
Novo Nordisk’s new suit against Wells Pharmacy Network alleges the presence of a substance called BPC-157, banned by the FDA in September. The FDA cited insufficient data on its safety for humans but noted potential dangerous immune system reactions. The lawsuit against Brooksville Pharmaceuticals contends that its products had lower semaglutide levels than advertised, putting patients at risk of taking less effective drug products.
Novo Nordisk emphasizes that compounded products lack the same safety, quality, and effectiveness assurances as FDA-approved drugs, exposing patients to significant health risks. The FDA had previously warned about the safety risks of unauthorized versions of Ozempic and Wegovy, prompting several states to threaten legal action against compounding pharmacies distributing unapproved variations of Novo Nordisk’s treatments.
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