Novo Nordisk files 11 more compounded semaglutide lawsuits, bringing total to 34

Novo Nordisk filed 11 new lawsuits in August 2024 against medical spas, weight-loss clinics and telehealth companies that advertise compounded semaglutide, the molecule sold as Ozempic, Wegovy and Rybelsus. The filings bring Novo's total to 34 legal actions against compounders, six of which have resulted in permanent injunctions ^[1].

The new cases were filed in California, Florida, Michigan, New Jersey, Oklahoma, Pennsylvania and Washington ^[1].

Eli Lilly, which makes the tirzepatide drugs Mounjaro and Zepbound, told investors that samples it collected from compounding labs often did not contain its drug at all. Dan Skovronsky, Lilly's chief scientific and medical officer, said on an August 8, 2024 earnings call: "We often are able to secure samples from these kinds of compounding labs and analyse them in our own labs. And what we found for the most part, in most instances, is this isn't [our] kind of tirzepatide at all." He said compounders are "purchasing either other chemicals entirely, which we often find, or make [products] of tirzepatide that [are] often full of impurities [and] sometimes contaminated by bacteria" ^[1].

Lilly said it found compounded products advertised as tirzepatide that contained bacteria or high impurity levels, were pink rather than colourless, or had a completely different chemical structure from its approved medicines. In at least one instance, the company said, the product was nothing more than sugar alcohol ^[1].

What regulators have reported

Between August 2021 and mid-July 2024, the FDA reviewed 288 reports of patients having bad reactions to compounded semaglutide and 108 such reports for compounded tirzepatide, the agency told the Washington Post. Some patients required hospitalisation ^[1].

In July 2023, the FDA issued a warning after receiving several reports of adverse effects from people who used compounded semaglutide, including dosing errors. Some patients sought medical attention or required hospitalisation after a medication error ^[1]. Since late 2023, the FDA has issued 10 warning letters over misbranded, adulterated or illegal sales of semaglutide and tirzepatide. The recipients included US Chem Labs, Synthetix Inc. (doing business as Helix Chemical Supply), AnuMed International, and the websites gorillahealing, semaspace, Ozempen and dashpct; none of those facilities was registered as a human drug compounding outsourcing facility under section 503B of the Federal Food, Drug and Cosmetic Act ^[1].

Compounding is a long-established practice that allows dosing, formulation and delivery method to be tailored to an individual patient, and it can be cheaper than FDA-approved products in some situations. The FDA allows compounders to make their own version of a drug when it is in shortage. Ozempic and Wegovy were both placed on the FDA's drug shortage list in May 2023, and shortages have lessened since then ^[1].

Other countries have acted. On May 21, 2024, the Australian government announced a complete ban on compounded tirzepatide and other compounded diabetes and weight-loss medicines, citing "increasing reports of patients coming to harm from [compounded versions] including the hospitalisation of a patient in Australia due to a serious adverse event" ^[1]. Scott Gottlieb, a former FDA commissioner, said many compounded GLP-1 versions are a "salt" formulation that is likely more soluble and does not provide the extended release of the weekly brand versions, so "they won't deliver the expected benefit" ^[1].

Why it matters for patients

Compounded drugs do not undergo pre-market review for safety, effectiveness or quality, which the FDA says makes them a higher risk to patients than approved products ^[1]. Problems found in tested samples include too little, too much or no active ingredient, the wrong or harmful ingredients, bacterial contamination and impurities ^[1].

That matters most for people who turn to compounding because of cost, insurance coverage or trouble finding a brand-name product during a shortage — the same group the FDA says it recognizes has substantial interest in compounded semaglutide ^[1]. A product that is a different chemical, a different formulation or nothing but sugar alcohol would not be expected to work the same way as the approved drug ^[1].

How many people in the US currently use compounded semaglutide or tirzepatide has not been reported, and the outcomes of the 11 new lawsuits have not been disclosed ^[1]. Novo's cases to date have produced six permanent injunctions out of 34 actions ^[1].