Novo Nordisk Cracks Down on Unsafe Compounded “Semaglutide” with New Wave of Lawsuits

Novo Nordisk has filed 14 new lawsuits aimed at protecting patients from unapproved and potentially unsafe compounded drugs marketed as containing “semaglutide.” The lawsuits target entities accused of misleading patients into believing these compounded products are FDA-reviewed or comparable in safety and efficacy to Novo Nordisk’s approved semaglutide medications. Novo Nordisk asserts that these compounded products are unauthorized copies made with unverified foreign active pharmaceutical ingredients and lack proven safety or effectiveness.

132 Lawsuits Filed Across 40 States Targeting Pharmacies and Telehealth Companies 

Novo Nordisk has intensified its legal efforts to safeguard patient health by filing 132 complaints in federal courts across 40 states. These lawsuits target companies whose marketing and business practices allegedly violate the law and jeopardize patient safety. The latest round of lawsuits builds upon previous legal victories and broadens the company’s focus to include two new areas of concern.

The expanded legal actions now address pharmacies that produce unapproved compounded “semaglutide” drugs under the false pretense of personalized care, allegedly in violation of state regulations. Additionally, Novo Nordisk is pursuing telehealth companies that it claims improperly influence treatment decisions by directing patients toward compounded versions of “semaglutide.” These practices, the company argues, are carried out under misleading claims of personalization and contravene California law by allowing corporations rather than licensed medical professionals to guide patient care.

To date, courts have granted 44 permanent injunctions in related cases, barring defendants from unlawfully compounding or misrepresenting compounded “semaglutide” as FDA-approved or equivalent to authorized Novo Nordisk medications such as Wegovy and Ozempic. Some rulings have also required companies to relinquish profits gained through these practices, underscoring the legal system’s efforts to curb unsafe and deceptive activities in the pharmaceutical space.

“Patients deserve safe, effective treatments from companies they can trust. No one should have to gamble with their health by using knockoff drugs made with ingredients that lack oversight and safety standards,” said Dave Moore, Executive Vice President, US Operations of Novo Nordisk Inc. “Novo Nordisk is addressing this issue through education, advocacy, and legal action against businesses that mislead Americans and jeopardize their health with unsafe and unapproved knockoffs. We urge regulators to enforce laws designed to protect public health.”

FDA Alerts Safety Risks Linked to Compounded Semaglutide Made with Unregulated Chinese Ingredients

The U.S. Food and Drug Administration (FDA) has issued several safety alerts, most recently, warning healthcare professionals and patients about the dangers of compounded “semaglutide” made with unregulated foreign active pharmaceutical ingredients (API). These warnings follow reports of serious adverse events, including accidental overdoses involving five to 20 times the intended dosage, in some cases leading to hospitalization. The FDA has emphasized the risks associated with these unapproved knockoff products.

Independent investigations have further highlighted the safety concerns. A Brookings Institution report revealed that many compounded “semaglutide” products rely on synthetic API imported from Chinese facilities lacking FDA oversight or quality assurance. Notably, 60% of the Chinese manufacturers exporting this API have yet to receive authorization to distribute it for human use in China. FDA data shows that since June 2023, all semaglutide used for compounding in the U.S. has originated from Chinese suppliers. This raises concerns about the quality and safety of these substances.

In response, Novo Nordisk has launched public education initiatives to inform patients of the risks. Campaigns like “Check Before You Inject” and “Choose The Real Thing” aim to help patients identify and avoid counterfeit and compounded semaglutide products. The company also established semaglutide.com, offering guidance on how to access FDA-approved medications like Wegovy and Ozempic. 

Author

Denisse Sandoval

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