The Food and Drug Administration is warning people to stay away from suspect sources of semaglutide, the active ingredient in popular weight loss drugs Wegovy and Ozempic. The agency has received reports of adverse effects from people using semaglutide created by compounding pharmacies. Additionally, some of these pharmacies are producing different forms of semaglutide that haven’t been tested for their safety and effectiveness.
Semaglutide is a synthetic and longer-lasting version of glucagon-like peptide 1 (GLP-1) developed by the company Novo Nordisk. GLP-1 and similar hormones help regulate our hunger and metabolism, often by affecting the release of other hormones such as insulin. As a result, GLP-1-based drugs, like semaglutide, have been used for over a decade to help people manage their type 2 diabetes. But more recently, it has emerged as the first in a new generation of obesity treatments. In clinical trials, people taking semaglutide have lost up to 15% of their baseline weight over a year’s time—well above the typical weight loss seen with other medications or lifestyle changes alone.
The FDA approved Novo Nordisk’s Wegovy in June 2021 to treat obesity. But production problems and higher-than-expected demand soon led to shortages of the drug. This demand has also led to shortages of Ozempic, the lower-dose brand of semaglutide approved for diabetes, as doctors began to prescribe it off-label for weight loss.
The immense popularity of semaglutide, coupled with the low supply and high list price of either brand (without insurance, Wegovy can cost upwards of $1,500 a month), has fueled a black market for it. And one of the most common sources of sketchy semaglutide has come from compounding pharmacies.
These pharmacies are typically used to create custom-made drugs for patients with special needs, such as drugs free of certain allergens. But some direct-to-consumer companies or the pharmacies themselves are now selling compounded semaglutide simply to make a buck. These drugs tend to be sold at far lower prices than Wegovy and will often be packaged with other ingredients, like vitamin B12. But the production of compounded semaglutide is completely unregulated and patients can’t even be sure that they’re getting the real deal.
Novo Nordisk has predictably disavowed the use of compounded semaglutide, stating that they do not sell the active ingredient to these pharmacies. On Tuesday, the FDA issued its own warning, stating that it has recently gotten adverse event reports after patients used compounded semaglutide.
The FDA doesn’t go into any detail about these reports in its announcement. And just because someone experiences adverse effects after taking a drug, that doesn’t necessarily mean that the drug was the cause. But the agency has also received reports of pharmacies using salt forms of semaglutide to create their drugs, as opposed to the base form used by Novo Nordisk. The ongoing shortages of semaglutide might provide a narrow justification for compounding pharmacies to produce their own versions, but using these salt forms to do so isn’t authorized, according to the FDA. Local pharmacy regulators have also expressed their disapproval of the practice.
“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations,” the FDA said in its warning published Tuesday. “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”
The availability of Ozempic and Wegovy has gotten better lately. And similar drugs (including an oral version of semaglutide) will likely soon receive FDA approval, providing more options for patients. But Novo Nordisk still expects partial shortages of Wegovy to continue on through September 2023 at the very least, and its list price will remain high for the foreseeable future. So it’s likely that compounded semaglutide will continue to be tempting for some people to roll the dice on.