FDA warns against off-brand versions of Wegovy, Ozempic

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As the U.S. continues to face a shortage of semaglutide medications like Wegovy, Ozempic and Rybelsus, many consumers have turned to compounding pharmacies for off-brand versions of the popular diabetes and weight loss drugs.

However, the U.S. Food and Drug Administration is warning patients that these modified medications could potentially be unsafe and said it has received several “adverse event reports” associated with some forms of compounded semaglutide.

The FDA did not say what types of health issues or risks it was informed of, but reminded patients and doctors in a May 31 notice that compounded versions of medications are neither FDA-approved or evaluated for safety, effectiveness or quality.

Under federal law, compounding pharmacies are permitted by the FDA to prepare compounded versions of medications currently listed in short supply, which is the case with Ozempic and Wegovy, two popular drugs made by Novo Nordisk.

“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. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective,” agency officials said.

The federal agency also emphasized that there are currently only three FDA-approved semaglutide products – injectables Ozempic and Wegovy and Rybelsus, which is an oral tablet – all are available only with a prescription, and that “there are no approved generic versions.”

“FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements,” the agency added.

Consumers should only use drugs containing semaglutide with a prescription from a licensed health care provider and obtained from a state-licensed pharmacy or other facilities registered with the FDA, the agency said.

Going viral

Ozempic is a treatment for adults with Type 2 diabetes that is self-injected under the skin and was approved by the FDA in 2017. The drug works by mimicking a natural hormone the body releases when a person eats, potentially causing weight loss as a secondary effect.

On the other hand, Wegovy was authorized in June 2021 specifically for chronic weight management in adults who are obese or overweight with at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

Wegovy was on the market for about six months when Novo Nordisk announced it was in short supply, attributing the shortage to an issue with its contracted manufacturer. After that, many physicians reportedly shifted to off-label prescriptions for semaglutide diabetes drugs Ozempic and Rybelsus for patients who needed or wanted to lose weight but could not access Wegovy.

This trend intensified under the influence of social media campaigns promoting semaglutide as a quick fix for weight loss, eventually leading to shortages, as well, and prompting the company to take a multipronged approach to recover supply levels.

After becoming aware that “several compounding pharmacies, weight loss clinics and medical spas are claiming to sell or offer compounded products purporting to contain semaglutide,” 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 company said in a statement to NJBIZ.

The drugmaker – which has its U.S. headquarters to Plainsboro – also said, “Compounded products do not have the same safety, quality, and effectiveness assurances as our FDA-approved drugs, and may expose patients to health risks.”

It went on to note that Novo Nordisk is the only company in the U.S. with FDA-approved products (Wegovy, Ozempic and Rybelsus) and that regulators have yet to sign off on any generic versions of semaglutide.

As for the off-brand products “claiming to contain semaglutide that are not one of our own branded products,” Novo Nordisk said it cannot validate their safety and effectiveness nor does it sell semaglutide for the purposes of compounding.