Eli Lilly has warned that compounded tirzepatide mixed with vitamin B12 may pose patient safety risks.
Testing of compounded products marketed in the U.S. that combine tirzepatide with B12 found significant levels of an impurity caused by a chemical reaction between the two ingredients, the company said in a March 12 news release.
According to Lilly, the impurity is concerning because its effects in humans are unknown, adding that dangers include potential toxicity, immune reactions and interactions with GLP-1 and GIP receptors. The company said it notified the FDA of the findings and urged patients using compounded tirzepatide-B12 products from compounders, telehealth companies or medspas to consult their physicians about treatment options.
The Alliance for Pharmacy Compounding questioned Lilly’s claims in a March 12 statement. Scott Brunner, CEO of the organization, said the drugmaker has not provided enough information about the source or handling of the sampled products or the nature and level of the reported impurity to allow outside experts to evaluate the findings.
Mr. Brunner said the APC would take any verified safety risk seriously but urged Lilly to share additional data with regulators and the public, adding that the announcement “raises more questions than it answers.”
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