Novo Nordisk Sues Pharmacies Compounding Contaminated Semaglutide

The drug manufacturer Novo Nordisk has announced that it is taking legal action against compounding pharmacies and medical spas offering copycat versions of medications claiming to contain semaglutide, the active ingredient in Novo Nordisk’s diabetes drugs Ozempic, Wegovy, and Rybelsus. Diabetes medications have become incredibly popular among the public for their weight loss properties and are in high demand, leading some compounding pharmacies to take matters into their own hands.

Novo Nordisk is suing 2 Florida compounding pharmacies – Wells Pharmacy and Brooksville Pharmaceuticals – alleging that the pharmacies are compounding contaminated versions of Novo Nordisk’s medication. In a statement, the company expressed concerns about the significant health risks the adulterated products could cause. “Following several analyses of compounded drugs claiming to contain semaglutide, 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 patients’ health at risk,” said Jason Brett, Executive Director, Medical Affairs at Novo Nordisk. “Our priority is to protect patient safety and to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines.”

The company announced that testing of the products from the 2 compounding pharmacies revealed alarming findings, including products containing a peptide (BPC-157), which in September 2023 the FDA announced cannot be used in compounding due to significant safety risks; the presence of unknown impurities (up to 33% in one sample); and peptide-related impurities in the products that have the potential to stimulate an immunological reaction. Also noted was that the strength of the compounded products was inaccurate, including a sample that was at least 19% less than the labeled strength. Novo Nordisk is seeking a court order preventing the pharmacies from compounding the product and providing false information to the public.

In the same statement, the company announced that it had now filed a total of a dozen legal actions against compounding pharmacies (5), and medical/weight-loss spas (7). Novo Nordisk has so far obtained preliminary injunctions against six medical spas, preventing them from misinforming patients into believing that their compounded drugs are genuine, FDA-approved, or associated in any way with Novo Nordisk.

Reference

Novo Nordisk takes additional legal actions to help protect US patients from potentially unsafe and ineffective compounded drugs claiming to contain semaglutide that are not FDA approved. Novo Nordisk. Published November 29, 2023. Accessed January 5, 2023. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=166352