On November 30, Novo Nordisk said that it found up to 33% of impure compounded Wegovy, a well-known weight loss medication.
As a result, the company initiated a lawsuit against one compounding pharmacy and reactivated a case against another.
The Danish pharmaceutical company reported discovering contaminants in all the drugs it examined from Brooksville Pharmaceuticals and Wells Pharmacy in Florida. When Novo Nordisk first sued Brooksville in July, they detected BPC-157 in Wells' sample material.
In September, the U.S. Food and Drug Administration (FDA) prohibited the use of BPC-157 in compounded medications, stating that there was insufficient data to determine if it was toxic to people but that it might trigger serious immune system responses.
On November 29, both suits were filed in Florida. On November 30, the pharmacies have yet to respond to an email requesting comments.
The compounded forms of Wegovy tested from Brooksville were less potent than advertised, with one sample being at least 19% weaker than reported.
The concern with compounded products is that their efficacy, quality, and safety are not the same as drugs that are FDA-approved, leaving the consumer at odds with a health risk.
According to Novo Nordisk, the lawsuits are intended to stop the two pharmacies from selling goods that purport to contain semaglutide, which is the active ingredient in Ozempic and Wegovy, as well as to stopping Wells Pharmacy from asserting that BPC-157 has health benefits or that its products are FDA-approved without disclosing to consumers any potential safety risks.
The pharmaceutical company has already brought twelve lawsuits against medical spas, weight-loss centers, and compounding pharmacies that sell goods purportedly containing semaglutide.
The business added that to prevent six of them from falsely representing that their products are genuine, FDA-approved, or connected to Novo Nordisk, it has acquired interim orders against them.
Several medical spas, weight-loss clinics, and compounding pharmacies have been sued by Novo Nordisk’s main competitor in the obesity drug market, Eli Lilly, this year to prevent them from offering products that appear to contain tirzepatide, which is the active ingredient in Novo Nordisk’s diabetes medication Mounjaro and the recently approved weight-loss medication Zepbound.
The U.S. District Court's Middle District of Florida, Ocala division, received the lawsuit against Wells, while the Middle District of Florida, Tampa division, received the action against Brooksville.
Between 2020 and October 5, the FDA's Adverse Events Reporting System had 38 complaints of counterfeit semaglutide.
Of these, 25 are classified as dangerous instances; they include side effects such as pancreatitis, acute renal damage, loss of consciousness, and miscarriage. Two of these cases are associated with mortality.
Twelve cases of fake tirzepatide, the generic name for the diabetic treatments Zepbound and Mounjaro, were reported between 2020 and September.