Compounded weight-loss drugs that include vitamin B12 and the same main ingredient found in Zepbound from Eli Lilly and Company may pose health risks to consumers because of a previously unidentified impurity that can occur during preparation, the U.S. drugmaker said in a public letter released on Thursday.
The letter, based on the company’s testing of samples of compounded products, marks Lilly’s latest action against drug compounders that it says are selling illegal copies of Zepbound and its diabetes drug Mounjaro. Both medications contain the same active ingredient, Tirzepatide.
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Eli Lilly and Company has filed lawsuits against compounders, wellness centers, and other businesses that are selling products claiming to contain Tirzepatide.
Compounders, however, argue that their products are legal under a limited provision of U.S. federal law that allows drug compounding when patients need customized treatments for medical reasons, such as adding vitamins or providing dosage strengths that are not available in branded medicines.
According to a public letter and a scientific manuscript shared with Reuters, Lilly tested products obtained from compounding pharmacies, medspas, and telehealth networks and discovered “significant levels of an impurity” caused by a chemical reaction between tirzepatide and Vitamin B12.
The impurity was identified in all 10 samples it tested, the company said.
“FDA warns that compounded products can be risky for patients because they are not reviewed for safety, effectiveness, or quality,” Eli Lilly Chief Medical Officer David Hyman said in a statement. “Adding a reactive substance like vitamin B12 without clinical testing or FDA review introduces additional unknown risks.”
Lilly said it notified the U.S. Food and Drug Administration of its findings and called for a nationwide recall of products containing both ingredients.
Scott Brunner, CEO of the lobby group Alliance for Pharmacy Compounding, said Lilly’s findings were concerning but that the company would need to provide details of its sampling process, how the tested samples were obtained and other specifics to fully assess any health risks to consumers.
“Based on what I’ve read so far, Lilly isn’t telling us enough to make that determination,” Brunner said.
The U.S. Food and Drug Administration issued warning letters in September to 30 telehealth companies for making false or misleading claims about compounded versions of weight-loss drugs.
The agency also warned that it could take action against “illegal copycat drugs” after Hims & Hers Health announced in February that it planned to sell its own version of Novo Nordisk’s weight-loss pill Wegovy.
Soon after, Hims & Hers withdrew its plan for the compounded pill and announced this week that it would instead sell Novo Nordisk’s Wegovy and Ozempic on its platform.
