(Bloomberg) -- Novo Nordisk A/S is suing two more compounded pharmacies over knock-off versions of Ozempic, including products found to contain a peptide that US regulators have deemed unsafe.
“We have seen concerning levels of unknown impurities as high as 33 percent and lower levels of strength than labeled in the compounded products, which could potentially put patient’s health at risk,” Jason Brett, executive director of medical affairs for Novo’s US affiliate, said in a statement released Thursday.
Novo has filed a total of 12 legal actions against medical spas, weight-loss clinics and compounding pharmacies selling dupes of its popular weight-loss and diabetes drugs. Rival drugmaker Eli Lilly & Co. has taken similar action against businesses hawking knock-offs of its blockbuster diabetes drug Mounjaro.
Products made by Wells Pharmacy Network, which is now facing lawsuits from both Novo and Lilly, were found to contain a peptide called BPC-157 that the US Food and Drug Administration has deemed unsafe, Novo said.
The FDA warned consumers about BPC-157 in September and said it would consider taking legal action against compounding pharmacies for using it in products. The World Anti-Doping Agency has also banned the substance, which it says hasn’t been sufficiently studied.
“Compounded drugs containing BPC-157 may pose risk,” according to the FDA. “We lack sufficient information to know whether the drug would cause harm when administered to humans.”
The FDA doesn’t have the same oversight of compounded drugs as it has with traditional prescription ones. It has warned consumers about complaints of safety issues with compounded semaglutide, the active ingredient in Novo’s Ozempic and Wegovy, saying that “patients should not use a compounded drug if an approved drug is available to treat a patient.”
Novo is also suing Brooksville Pharmaceuticals, a compounding pharmacy based in Florida.
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