On Thursday, Eli Lilly, the maker of tirazepate, issued a warning to the public. The company claims it has identified “significant levels of impurity” in combination medicines combining tirazeptide with vitamin B12. Health officials have previously advised people to stay away from these adapted versions of GLP-1s.
“People obtaining tirazeptide-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 company said.
mixed risk
Compounded medications are custom-made formulations of existing medications that can be produced by pharmacies under certain circumstances.
For a time, pharmacies were given wide latitude to make GLP-1 drugs such as semaglutide (Ozempic and Vegovy) and tirazeptide, which were in shortage. People have not turned to compound GLP-1 simply because they are available. They are significantly cheaper out of the pocket than the official versions, which are often not covered by private or public insurance carriers (Wegovi’s list price was initially around $1,400 per month). However, this shortage has long since ended.
Some compounding pharmacies and distributors claim that they can still sell these products if they are adapted to the specific health needs of customers (this is actually the normal practice of compounding pharmacies). Often, these outlets claim to produce personalized GLP-1 by combining it with vitamins such as B12 or other ingredients, some even marketing them as enhanced versions.
However, the FDA is not accepting that justification, and has tried to put a stop to the continued and potentially illegal mass marketing and distribution of mixed GLP-1s. Both Eli Lilly and Novo Nordisk (makers of semaglutide) have also taken legal action against several compounder distributors, with several lawsuits still pending in the courts.
As part of Eli Lilly’s campaign against mixed GLP-1s, the company tested marketed products containing tirazepate and B12. In these products, it reportedly identified impurities that may have resulted from a chemical reaction between the two ingredients. The company said it has sent its results to the FDA.
While B12 is a common addition to compound GLP-1s, it is far from the only one.
“A large number of compounders and so-called ‘personalizers’ are combining tirazeptide with glycine, pyridoxine, niacinamide, carnitine or other chemicals to circumvent the law, creating a range of new and untested combination drugs,” the company said in its warning Thursday.
What to make of mixed GLP-1s?
Obviously, Eli Lilly has a vested interest in eliminating any unauthorized imitations of its extremely popular weight loss drugs. But this does not mean that the company is wrong to do so.
While compounding pharmacies have their place in medicine, they certainly were not intended to serve as gray market offshoots for FDA-approved drugs — drugs that have to go through a lengthy process to test their safety and effectiveness. This process is not necessarily perfect, but it has many more safety measures than compounded medications.
The FDA notes that it has collected reports of compounded GLP-1 not being adequately refrigerated or being made with poor quality ingredients. In some cases, people have received labeled compounded GLP-1 coming from pharmacies that did not actually compound the drug or seemingly did not exist. According to the FDA, adverse events associated with compounded GLP-1 include injection site redness, swelling, pain, and a red lump at the injection site.
Earlier this week, the company Himes, perhaps the best-known source of compounded GLP-1s, announced that it would stop marketing these drugs as part of a cease-and-desist formed with Novo Nordisk. This new agreement may signal the beginning of the end for compounded GLP-1, due to legal pressure from the FDA and GLP-1 manufacturers, as well as a steady decline in list prices for authorized products, which are now finally close to the prices of compounded versions.
Taking these medications over the real thing is always a gamble. Soon, it may become very difficult to even achieve them in the first place.
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