Eli Lilly (LLY) has issued a public warning about potential safety risks associated with compounded tirzepatide mixed with vitamin B12.
Lilly tested compounded products and found “significant levels of an impurity” that results from a chemical reaction between the vitamin and tirzepatide, the active ingredient in the drugmaker’s blockbuster weight-loss drug Zepbound.
“People receiving tirzepatide-B12 products from compounders, telehealth companies, medspas, or anyone else should be aware that they may be using a potentially dangerous product with unknown risks,” the drugmaker said, citing possible toxicity and immune reactions. The company urged the FDA to recall all compounded tirzepatide products combined with untested additives.
Lilly (LLY) also warned that some compounders are mixing tirzepatide with other substances, including glycine, pyridoxine, niacinamide, and carnitine, in attempts to circumvent restrictions. The company said these additives have no proven clinical benefit for patients taking tirzepatide and could introduce additional safety risks.
Like its rival Novo Nordisk, Eli Lilly (LLY) is facing pressure from cheaper copycat versions of its obesity and diabetes injections that bypass the strict regulatory approval process required for branded or generic drugs.
These compounded medications were initially permitted in the U.S. to address supply shortages during the early surge in demand for weight-loss injections. However, the U.S. Food and Drug Administration has since declared the shortage resolved, meaning the lower-cost compounded versions are no longer allowed.
The FDA also recently said it plans to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers (HIMS) and other compounding pharmacies, as similar alternatives to FDA-approved drugs.
LLY shares were down -0.18% premarket, while HIMS soared +6.4% and NVO -0.3%.
Hims & Hers (HIMS) has been on the rise after a deal with Novo Nordisk (NVO) to offer Novo’s GLP-1 weight loss drugs and discontinue marketing its compounded GLP-1 products.