Tyler Patchen
News Reporter
The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.
The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.
Novo Nordisk’s Ozempic and Wegovy, both of which contain semaglutide, are approved to treat type 2 diabetes and obesity, and demand for the drugs has soared over the last two years, given the ability of both therapies to help people lose weight. That demand has created a supply crunch, with both medications on the FDA’s shortages list.
Though compounding medications is legal when drug shortages occur, the compounded versions of drugs need to follow requirements set out in the Food, Drug, and Cosmetic Act.
“The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded,” the regulator said.
The FDA said it contacted the National Association of Boards of Pharmacy last month, stating its concerns with compounding pharmacies using the salt forms of semaglutide.
“We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal law requirements that limit the types of active ingredients that can be used in compounding,” the FDA wrote in an April 27 letter.
The Alliance for Pharmacy Compounding (APC), an advocacy group for the compounding industry, said it’s aware that pharmacies may be distributing compounded drugs that contain the salt version of semaglutide.
“Until more is known about whether or not semaglutide sodium is an active pharmaceutical ingredient used in either of the FDA-approved drug products, it is APC’s current position that compounding with semaglutide sodium technically is not eligible to be used in a compounded medication,” the APC said.
Novo Nordisk is also aware of instances of compounded semaglutide, and the Danish drugmaker has said it’s issued cease-and-desist letters to compounding pharmacies, weight loss clinics, and medical spas that are selling or offering products claiming to contain semaglutide, a company spokesperson told Endpoints News in an email.
“Novo Nordisk is actively monitoring and taking action (including but not limited to issuing cease-and-desist letters) against these entities that are engaging in the unlawful sale of compounded semaglutide, disseminating false advertising and infringing its trademarks,” the spokesperson said.
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