Novo Nordisk files nine more lawsuits over compounded semaglutide

Novo Nordisk announced on May 30, 2024 that it filed nine new lawsuits against medical spas, weight-loss clinics, pharmacies and other sellers in Colorado, Florida, Illinois, Montana, Tennessee and Texas ^[1]. The company said these cases add to 12 earlier lawsuits, five of which have already ended in judgments barring the defendants from deceptive and illegal marketing tied to compounded versions of semaglutide ^[1].

Novo Nordisk is the only US company with FDA-approved semaglutide medications — Ozempic, Wegovy and Rybelsus — and it does not sell semaglutide for compounding ^[1]. The lawsuits claim the pharmacies, med spas and clinics unlawfully marketed and sold compounded products that claimed to contain semaglutide but did not meet that description ^[1].

The testing numbers

According to Novo Nordisk, lab testing of some compounded products found no semaglutide at all in certain samples, while others showed impurity levels as high as 24% ^[1]. The company said one defendant, an online retailer, sold "semaglutide" directly to patients without requiring a prescription ^[1]. Novo Nordisk also pointed to concerns about advertisements instructing people on how to make injectable semaglutide at home ^[1].

The company cited FDA Adverse Event Reporting System data as of March 31, 2024, showing 442 adverse event reports tied to compounded products claiming to contain semaglutide. Of those, 319 were classified as serious, including 99 hospitalizations and 7 deaths ^[1]. Doug Langa, an executive vice president at Novo Nordisk, said non-FDA-approved compounded drugs claiming to contain semaglutide with known and unknown impurities "pose significant risks to patients and may lead to serious and life-threatening reactions," and said the company would keep pursuing legal action against what it considers unsafe compounded products ^[1].

Why it matters for patients

Compounded semaglutide has become common at med spas and online clinics, often marketed as a cheaper alternative to brand-name Ozempic or Wegovy. The testing results Novo Nordisk cited raise a basic question for anyone considering these products: whether the injection actually contains the drug it claims to contain, and in what amount. A product with no active ingredient would not be expected to work as intended, and one with high impurity levels carries risks the FDA has not evaluated for these formulations ^[1].

The scale of the adverse event numbers — 442 reports, with 99 hospitalizations and 7 deaths as of the end of March 2024 — is tied specifically to compounded products claiming to contain semaglutide, according to Novo Nordisk's citation of FDA data ^[1]. The source does not say how many of those cases were confirmed to involve the impurity or purity problems described in the lawsuits, or how they compare with adverse event rates for FDA-approved semaglutide products. That distinction is not addressed in the available reporting.

The legal actions target the businesses selling these compounded products rather than individual patients, and the judgments so far have focused on stopping deceptive marketing rather than criminal penalties ^[1]. For people already using or considering compounded semaglutide, the lawsuits signal that questions about product content and sourcing are now the subject of active litigation in multiple states.

What happens next

The source notes that more lawsuits are likely as demand for semaglutide products continues to grow, though it does not specify dates for hearings or rulings in the nine new cases ^[1]. It is not yet known from available reporting how the remaining active lawsuits, beyond the five earlier judgments, will be resolved or what additional enforcement steps Novo Nordisk or regulators might take.