January 17, 2024

FDA Issues Respective Warnings for Compounded and Counterfeit Semaglutide

The FDA has recently issued two separate communications regarding semaglutide – a drug gaining strong popularity for weight loss – noting concerns with compounded semaglutide, as well as reports of counterfeit semaglutide products.

Semaglutide is currently available as the brand drugs Ozempic and Wegovy, both of which are injectables, as well as Rybelsus, an oral tablet. Semaglutide was originally approved for the treatment of type 2 diabetes, but was found to assist with weight loss, leading to greater utilization for the treatment of obesity, in combination with diet and exercise.

The significance of semaglutide’s rising popularity cannot be understated, as the drug has received public endorsement from public figures such as Oprah and Elon Musk, with the TikTok hashtag for Ozempic receiving over 273 million views. Drug shortages have even been reported for semaglutide products.

Regarding compounded semaglutide, the FDA has received adverse event reports after patients used compounded semaglutide, including reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. These salt forms are different active ingredients than what is used FDA-approved semaglutide products, which contain the base form of semaglutide.

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.

The FDA also warned consumers about counterfeit Ozempic found in the U.S. drug supply chain. Thousands of units have been seized so far, with the FDA advising wholesalers, retail pharmacies, health care practitioners and patients to check the products they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057.

Some of these counterfeit products may still be available for purchase.

FDA and Novo Nordisk (the manufacturer of Ozempic) are testing the seized products and do not yet have information about the drugs’ identity, quality, or safety.

Additionally, analysis found the needles from these samples are counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.

Adverse events tied to this lot of counterfeit products include nausea, vomiting, diarrhea, abdominal pain and constipation.

Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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