FDA reports adverse effects of off-brand Ozempic amid ‘shortage’

The Food and Drug Administration is warning consumers not to use off-brand weight-loss drugs containing semaglutide, the active ingredient in Ozempic and Wegovy.

On Wednesday, officials warned about the dangers of drug compounding — which involves mixing or altering ingredients to create medication — after receiving reports of adverse effects after patients used compounded semaglutide.

The FDA said it received reports that drug compounds may be using salt forms of semaglutide, which contain different active ingredients than Ozempic or Wegovy.

“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,” officials wrote online, providing a letter addressed to the National Association Board of Pharmacy regarding the issue.

Semaglutide, meant for patients with type 2 diabetes, is a glucagon-like peptide-1 receptor agonist, meaning that it mimics the GLP-1 hormone released in the GI tract to signal fullness, helping people shed excess weight.

However, the semaglutide salts may not have the same effect as the prescription.

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

Compounded drugs are not FDA-approved, officials said, which means they have not been vetted for safety in humans.

“Patients should not use a compounded drug if an approved drug is available to treat a patient,” the FDA wrote. “Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”

But if there is a shortage of a particular drug, a compounded version could be produced if it meets certain FDA requirements.

As of Thursday, the agency listed both Ozempic and Wegovy as “currently in shortage.”

Officials warned people that products advertising semaglutide may not contain the same ingredients as FDA-approved drugs like Ozempic and Wegovy.

“Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA,” the agency stated, cautioning against purchasing drugs online from “unregulated, unlicensed sources,” as they could prove dangerous to consumers.

The FDA’s stark warning coincides with Hollywood’s Ozempic craze that has snowballed in recent months, as researchers concoct rival weight-loss injectables amid growing demand.

But the once-weekly jab comes at a hefty cost to patients’ wallets — to the tune of about $1,300 — prompting people to seek cheaper alternatives.

On TikTok, users are advertising Ozempic-like recipes to people eager to slim down before summer, while some swear by herbal supplements.

Dubbed “nature’s Ozempic,” a plant-derived supplement called berberine has captivated wellness enthusiasts, despite experts’ criticism that it’s a product of “diet culture” and potentially harmful.