Eli Lilly amplified its calls on the Food and Drug Administration to crack down on companies making compounded versions of its obesity shot Zepbound, saying Thursday that formulations that include vitamin B12 may be “dangerous” to patients.
Since the FDA declared an end to the shortages that gave compounders cover to sell copycat forms of Zepbound and Novo Nordisk’s Wegovy, these companies have exploited legal loopholes by marketing “personalized” versions containing vitamins or other additives.
In a “public warning” on Thursday, Lilly said its own testing has unearthed potential safety issues in personalized forms of tirzepatide, the active ingredient in Zepbound. According to Lilly, those experiments found “significant levels of an impurity” that results from a chemical reaction between tirzepatide and B12. That impurity is “concerning because nothing is known about its short- or long-term effects in humans,” Lilly added, warning that users “should be aware that they may be using a potentially dangerous product with unknown risks.”
The Indiana-based drugmaker asked the FDA to order a recall of all compounded tirzepatide containing personalized additives, which include other vitamin B and dietary supplements.
“The continued widespread distribution of untested compounded drugs is an unacceptable risk for patients,” Lilly said. “Our testing results of these so-called “personalized” compounded tirzepatide products show they may pose even greater risks to patients than previously known.”
Lilly and Novo have spent billions of dollars boosting their manufacturing capabilities, which has enabled them to better meet the widespread demand for the FDA approved versions of Zepbound and Wegovy. Still, compounders have continued to claim market share, denting sales of both products.
Both companies have taken legal action, headlined by a high-profile battle between Novo and telehealth company Hims & Hers. Last month, Hims & Hers attempted to launch a version of Novo’s Wegovy pill before quickly changing course amid a lawsuit from the Danish company and threats from the FDA. Now, the two companies have negotiated a truce, enabling Hims to sell Novo’s obesity medicines on its platform.
Amid the spat between Hims and Novo, the FDA declared plans to take “decisive steps” against compounders. Lilly praised the effort, and added, “we urgently call on other regulators and law enforcement to do the same.”
