Ozempic Craze Spawned Inaccurate Black Market, FDA Warns

The Food and Drug Administration warns people to stay away from suspicious 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 compounding drug-made semaglutide. Also, some of these pharmacies produce different forms of semaglutide that have not been tested for their safety and effectiveness.

Semaglutide is a synthetic and longer-acting version of glucagon-like peptide 1 (GLP-1) developed by the company Novo Nordisk. GLP-1 and similar hormones help regulate hunger and metabolism, often by affecting the release of other hormones such as insulin. Accordingly, based on GLP-1 drugs, Pleases 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 treatments for obesity. In clinical trials, people taking semaglutide lost up to 15 percent of their baseline weight in one year, well above the typical weight loss seen with other medications or lifestyle changes alone.

The FDA approved Novo Nordisks Wegovy in June 2021 for the treatment of obesity. But production problems and exceeded expectations the demand soon led to shortages of the drug. This demand has also led to a shortage of Ozempic, the low-dose brand of semaglutide approved for diabetes, as doctors have begun prescribing it off-label for weight loss.

Semaglutide\’s immense popularity, coupled with both brands\’ low supply and high list price (without insurance, Wegovy can cost as much as $1,500 a month), has fueled a black market for it. And one of the most common sources of sketchy semaglutide comes from compounding pharmacies.

These pharmacies are typically used to create custom medicines for patients with special needs, such as medicines that are free from certain allergens. But some direct-to-consumer companies or pharmacies themselves now sell compound semaglutide simply to make money. These drugs tend to be sold at much lower prices than Wegovy and often come packaged with other ingredients, such as vitamin B2. But the manufacturing of the compound semaglutide is completely unregulated and patients can\’t even be sure they\’re getting the real deal.

Novo Nordisk has predictably disavowed the use of the compound semaglutide, stating that they do not sell the active ingredient to these pharmacies. On Tuesday, the FDA issued its own warningstating that he recently received reports of adverse events after patients used the compound semaglutide.

The FDA does not go into the details of these reports in its announcement. And just because someone experiences adverse effects after taking a drug, it 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. Continuing semaglutide shortages could provide narrow justification for compounding pharmacies to produce their own versions, but using these forms of salt to do so is unauthorized, 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 saline formulations, the FDA said in its advisory. 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 Ozempico and Wegovy has gotten better lately. And similar drugs (including a oral version of semaglutide) will likely receive FDA approval soon, providing more options for patients. But Novo Nordisk still expects partial deficiencies of Wegovy will continue through at least September 2023 and its list price will remain high for the foreseeable future. So it\’s likely that the compound semaglutide will continue to be enticing for some people to roll the dice at.