Novo Nordisk Files 9 Lawsuits Related to Counterfeit Semaglutide

At the very end of May 2024, pharmaceutical manufacturer Novo Nordisk announced the filing of 9 new lawsuits against medical spas, weight loss clinics, pharmacies, and others in Colorado, Florida, Illinois, Montana, Tennessee, and Texas.

The Lawsuits

The 9 new lawsuits are in addition to 12 prior lawsuits filed so far, 5 of which have ended in judgments barring the defendants from deceptive and illegal marketing practices related to the sale of compounded versions of Novo Nordisk’s semaglutide.

Novo Nordisk is currently the only US company with FDA-approved medications containing semaglutide, and it does not sell the product for use in compounding. Novo Nordisk makes the semaglutide medications Ozempic, Rybelsus, and Wegovy.) The new lawsuits claim that the pharmacies, medical spas, and weight loss clinics were unlawfully marketing and selling compounded products claiming to contain semaglutide.

Novo Nordisk alleges that the pharmacies, spas, and medical clinics that are purporting to sell compounded semaglutide are a great danger to the public. According to Novo Nordisk, testing of the compounded medications from pharmacies revealed no semaglutide at all, as well as up to 24% impurities, which could expose patients to significant health risks.

The drug manufacturer claims that one defendant–an online retailer–was selling “semaglutide” directly to patients without requiring a prescription. The company pointed out the latest statistics from the FDA Adverse Event Reporting System data–as of March 31, 2024, there were 442 cases of adverse events associated with compounded medications claiming to contain semaglutide. Of those, 319 were classified as “serious” adverse events with 99 hospitalizations, and 7 deaths.

The company has also expressed concerns over “potentially dangerous advertisements by retailers on how to make your own injectable semaglutide at home.”

“Non-FDA approved compounded drugs claiming to contain semaglutide with high levels of known impurities and unknown impurities pose significant risks to patients and may lead to serious and life-threatening reactions,” said Doug Langa, executive vice president, North America Operations, and president of Novo Nordisk. Mr Langa vowed to continue to pursue legal action against potentially unsafe compounded semaglutide products.

The Takeaway

It is highly likely that we will be seeing many more of these cases as the demand for semaglutide products grows. Patients should use caution when encountering compounded semaglutide products.

Reference

Novo Nordisk escalates legal actions to safeguard patients from potentially harmful compounded “semaglutide” drugs. News release; Novo Nordisk. May 30, 2024. Accessed June 14, 2024. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=168519