Be cautious of mixing Taipot peptide with other ingredients! Lilly (LLY.US) warns that cheap diet pills may contain hidden risks.
Lei warned that there are impurities in the weight loss drug, mentioning possible toxic and harmful overactive immune responses that may affect health. The latest tests also found other key safety issues, such as bacterial contamination and high levels of toxic components endotoxins.
Leading player in the American healthcare industry, Eli Lilly and Company (LLY.US) has issued a warning that the core active ingredient of its heavyweight weight loss drug, Zepbound, may pose significant risks to patient health when mixed with Vitamin B12. This combination is currently being sold by a US pharmaceutical compounding agency.
In a statement on Thursday, Eli Lilly stated that the company had tested the compounded products and found them to contain "significant levels of some impurities" which resulted from a chemical reaction between the vitamin and the active ingredient of Eli Lilly's weight loss drug, tirzepatide.
The American pharmaceutical manufacturer stated, "Anyone obtaining tirzepatide-B12 products from pharmaceutical compounding agencies, telemedicine companies, medical aesthetics institutions, or any other channel should be aware that they may be using a product that poses potential risks to human health." The company also mentioned the possibility of toxic and harmful overactive immune reactions.
Similar to its strongest competitor in the weight loss drug field, Novo Nordisk A/S Sponsored ADR Class B, Eli Lilly is facing pressure from cheaper generic and compounded versions of weight loss and diabetes injection drugs. These replicated versions bypass the strict regulatory approval process required for branded or generic drugs.
These generic and compounded drugs were allowed to be sold in the US market for a period to address the early supply shortages of weight loss injections. However, the Food and Drug Administration (FDA) soon declared the shortage over, meaning these discounted compounded and generic drugs are no longer allowed to be sold officially.
Despite this, some generic and compounding agencies continue to exploit a regulatory loophole to sell their products, allowing them to customize drug formulations - for example, slightly adjusting doses or adding other ingredients such as Vitamin B12.
It is understood that Eli Lilly has been urging the FDA to recall all compounded versions of tirzepatide products that have been mixed with additives not officially tested.
Eli Lilly stated that the latest tests also revealed other critical safety issues, such as bacterial contamination and high levels of toxic endotoxins.
Eli Lilly stated that these compounded weight loss drug versions are creating a range of new untested combinations by mixing tirzepatide with chemicals like alanine, pyridoxine, niacinamide, and carnitine. The company is urging the FDA to recall all compounded drugs containing untested additives.
The FDA had previously issued warnings to more than 30 telemedicine companies for misleading advertising of compounded GLP-1, aligning their enforcement focus with brand drug manufacturers.
In terms of sales and performance growth expectations, Eli Lilly's safety warning on the "tirzepatide + B12" compounded weight loss drug may signal a skew towards positive for its brand weight loss drug sales outlook, especially for Zepbound's share in the US cash market. For Eli Lilly, if the FDA recalls these untested compounded products, it signifies that the demand previously diverted to low-cost compounded tirzepatide may potentially flow back to compliant brand channels. However, as the American weight loss drug market is also experiencing price reductions and cash payment competition, this may not immediately lead to a significant increase in demand.
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