Novo Nordisk—manufacturer of diabetes and weight-loss drugs Ozempic and Wegovy—filed lawsuits against two pharmacies after tests concluded their products were impure, according to an announcement Thursday, the latest legal challenge by the Danish drugmaker against pharmacies selling their increasingly popular drugs.
The Danish drugmaker claims one pharmacy is adding a banned substance to its drugs.
Novo Nordisk said in a statement it has filed lawsuits against the Florida-based Wells Pharmacy Network and Brooksville Pharmaceuticals on Wednesday, alleging both pharmacies provided compounded drugs claiming to contain semaglutide—the generic name for Wegovy and Ozempic—that were up to 33% impure.
The unknown impurities “potentially pose safety risks” to consumers, including “possibly serious and life-threatening reactions” like anaphylaxis, Novo Nordisk said.
Novo Nordisk alleges Brooksville Pharmaceuticals was selling products that were at least 19% less effective than advertised.
Wells Pharmacy Network has “falsely and misleadingly” advertised an unapproved compounded drug that claims to contain the substance BPC-157, Novo Nordisk alleged, a substance banned by the Food and Drug Administration because there is insufficient evidence to know whether it is harmful to humans.
Wells Pharmacy Network allegedly claimed on the drug’s label that BPC-157 can “provide many benefits for the human body,” which is “likely to deceive” consumers into believing the FDA had approved the drug, according to the lawsuit.
Novo Nordisk is requesting both pharmacies stop selling products claiming to contain semaglutide, and wants Wells Pharmacy Network to be prevented from claiming its products with BPC-157 are approved by the FDA.
- That’s how many lawsuits Novo Nordisk has filed against medical spas, weight loss or medical clinics and pharmacies alleging the unlawful sale of unapproved drugs, according to the company. Of these, Novo Nordisk said it has received preliminary injunctions in six cases.
Novo Nordisk achieved success this year following the widespread adoption of the drugs Ozempic and Wegovy, which gained attention for their effectiveness in aiding weight loss. The FDA approved Wegovy for weight loss in 2021, while Ozempic is only FDA-approved for patients with type 2 diabetes and heart disease, though some doctors prescribe it off-label to help patients lose weight. It’s part of a boom in weight loss drugs: Zepbound—manufactured by Eli Lilly—was approved by the FDA earlier this month for adults who are obese or are overweight with at least one weight-related condition, like high blood pressure. Eli Lilly has filed similar lawsuits against pharmaceutical companies for selling drugs they claim contained tirzepatide. The U.S.-based drugmaker sued 11 online pharmacies last month, alleging the pharmacies falsely advertised unapproved drugs, including one product that was “nothing more than sugar alcohol,” according to Reuters.
There are 38 reports of counterfeit semaglutide in the FDA’s Adverse Events Reporting System between 2020 and October 5. Of these, 25 are listed as serious cases—resulting in adverse events like miscarriage, loss of consciousness, acute kidney injury and pancreatitis—and two resulted in death. There are 12 reports of fake tirzepatide—the generic name for diabetes and weight loss drugs Mounjaro and Zepbound—between 2020 and September.
Novo Nordisk Finds Compounded Wegovy Up To 33% Impure, Sues Florida Pharmacies (Reuters)