Eli Lilly and Company Issues Open Letter Warning About Potential Patient Safety Risks of Tirzepatide Compounded with Vitamin B12
Lilly is issuing a public warning about potential safety risks associated with compounded tirzepatide mixed with vitamin B12. As part of our commitment to patient safety, Lilly tested compounded products being marketed to Americans that contain tirzepatide combined with B12 (sometimes referred to as methylcobalamin, hydroxocobalamin, or cyanocobalamin). Our testing has uncovered significant levels of an impurity that results from a chemical reaction between tirzepatide and B12.
The impurity caused by the interaction between B12 and compounded tirzepatide is concerning because nothing is known about its short- or long-term effects in humans, the potential impact on the drug’s interaction with the GLP-1 and GIP receptors, toxicity, immune reactions, or how it is absorbed, distributed, metabolized and eliminated. The risks to patients are unknown because tirzepatide has never been studied in combination with B12 and the compounders making these combination drugs are not required to monitor or report adverse events.
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. Lilly has notified the U.S. Food and Drug Administration (FDA) about these findings and recommends that people using these untested products contact their physicians for advice and discussion on alternative treatment options.
Lilly has repeatedly expressed grave concerns about the safety of mass-compounded knockoffs of our tirzepatide medicines, Mounjaro® and Zepbound®, and we applaud the FDA’s recent announcement of its intent to take decisive action against the mass distribution of illegally compounded anti-obesity drugs. Even before its recent announcement, the FDA has consistently warned patients that compounded products “pose a higher risk” than FDA-approved medicines, because the FDA does not review compounded drugs’ safety, effectiveness or quality.
Although the FDA and a federal court have confirmed that mass-compounding of tirzepatide must stop, some entities continue to do it, claiming to offer “personalized” versions by adding untested additives, such as B12, to compounded tirzepatide. In reality, these products are not “personalized” at all. Most sellers put the same untested additives in all their tirzepatide knockoffs to try to evade FDA regulations. Our testing results of these so-called “personalized” compounded tirzepatide products show they may pose even greater risks to patients than previously known.
The potential for dangerous interactions between tirzepatide compounded with other additives remains unknown
Our discovery of this new impurity created when tirzepatide is compounded with B12 highlights the risks to patients of haphazardly mixing untested additives with complex molecules like tirzepatide without rigorous testing, clinical trials and FDA approval. B12 is just one of the many untested additives used in the mass production of compounded GLP-1s under the guise of “personalization.” Mass compounders and supposed “personalizers” seeking to circumvent the law are also mixing tirzepatide with glycine, pyridoxine, niacinamide, carnitine, or other chemicals, creating a range of new and untested combination drugs.
These additives have no proven clinical benefit for patients taking tirzepatide, and the resulting combinations introduce unknown risks for patients. We also continue to find other critical safety issues in compounded tirzepatide knockoffs, including bacterial contamination, high endotoxin levels, and other impurities that are not present in Lilly’s FDA-approved medicines.
The continued widespread distribution of untested compounded drugs is an unacceptable risk for patients. The FDA’s recent actions are an important step to enforce the law and protect patients, and we urgently call on other regulators and law enforcement to do the same. We also urge the FDA to continue taking action against unlawful mass compounding of tirzepatide that puts the American public at risk, including by requesting a recall of all compounded tirzepatide combined with untested additives like B12.
Source Link:https://www.lilly.com/news/press-releases
