As the Ozempic craze pushes advancements in weight-management medicine forward, pharmaceutical company Novo Nordisk, the company behind the so-called “miracle-drug,” is continuing to crack down on off-brand semaglutide products they say put patients in danger. The drug company announced Wednesday it has filed 12 legal actions in all against medical spas and compounding pharmacies they accuse of selling drugs with FDA-banned chemicals — and will continue to seek injunctions through the court until the practice stops.
Novo Nordisk is the parent company behind Ozempic, Rybelsus, and Wegovy, three of the most popular semaglutide products on the market. Semaglutide, which first became available in 2018, is a medicine that mimics the body’s naturally occurring GLP-1 hormone. It regulates sugar levels in the body, which is why semaglutide was originally developed and approved for diabetes patients. But the medication also works as an appetite suppressant, which quickly made it a desirable option as a weight-loss drug. The drug has seen such a dramatic increase in popularity that it’s been placed on a national shortage list by the Food and Drug Administration, and has remained there since May 2023. But with demand continually on the rise, patients have turned to telehealth companies and compounding pharmacies, who provide drugs mixed and tailored by a pharmacist but not manufactured by name-brand companies.
The two most recent lawsuits were filed against Wells Pharmacy and Brooksville Pharmaceuticals. In them, Novo Nordisk alleges that the compounding pharmacies are selling injectables marketed as semaglutide, which they claim is both misleading branding and potentially injurious to patients. The suit states that tests of the compounded semaglutide found “unknown impurities and impurities with amino acid additions and deletions not found in the pharmaceutical-grade semaglutide.” (Defendants Wells Pharmacy and Brookville Pharmaceuticals did not respond to Rolling Stone’s request for comment.)
“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 patient’s health at risk,” Jason Brett, Executive Director of Medical Affairs at Novo Nordisk Inc said in a press release Wednesday. “Our priority is to protect patient safety and to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines.”
According to Novo Nordisk, one of the pharmacies also was selling products that contained the peptides BPC-157, which both the FDA and the World Doping Organization have banned over a lack of information of its effects on humans.
Much of continued demand for compounded versions of semaglutide can be attributed to the high cost of the name brand medication and the lack of knowledge surrounding the purpose of compounding pharmacies in the U.S pharmacy system. Compounded drugs are not FDA-approved but the agency does acknowledge that they “can serve an important patient need,” most commonly used in cases where a patient has an allergy to an ingredient or needs it in a different form, like a liquid or injection instead of a pill. And semaglutide has remained on the FDA shortage list since 2022. But Novo Nordisk maintains that the safest way for patients to take semaglutide is through the FDA-approved versions of the drug.
“Patient safety is a top priority for Novo Nordisk,” Novo Nordisk adds. “And we continue to take action to protect patients and encourage responsible use of our FDA-approved semaglutide medicines.”