The agency is looking into reports of counterfeit Ozempic and other semaglutide medications, as well as potentially harmful issues associated with compounded versions of these weight-loss drugs.
Ozempic, Wegovy, and other semaglutide-based medications have become extremely popular for weight loss, with a notable 300% increase in sales between 2020 and 2022. Earlier this year, Ozempic and Wegovy manufacturer Novo Nordisk halted advertising of the drugs due to high consumer demand.
Now, the demand for these diabetes/weight loss drugs has led to an uptick in fraudulent activity — specifically, an increase in fake Ozempic and other money-making schemes.
In a recent alert letter to its members, the Pharmaceutical Cargo Security Coalition (PCSC) said the FDA is currently investigating a range of fraudulent activity involving Ozempic, semaglutide, and tirzepatide. The Coalition says the FDA Office of Criminal Investigations (OCI) has identified cases where licensed and unlicensed wholesalers have offered Ozempic at significant discounts to retailers.
However, in some instances, purchasers paid for Ozempic but did not receive the product. Even more concerning, some of the Ozempic came from foreign countries or were counterfeit.
Moreover, the PCSC says this illicit activity has been detected at distributor and pharmacy levels.
This wasn’t the first Ozempic counterfeit warning
In June of this year, Novo Nordisk warned the public about a counterfeit Ozempic pen found in the United States. The faux pen contained insulin glargine injection, a diabetes medication that works differently than Ozempic, and caused an adverse reaction.
According to the PCSC, the FDA is investigating these and other reports of counterfeit semaglutide and tirzepatide products sold via online retailers. This investigation follows previous reports involving illegal sales of these weight-loss drugs on social media platforms.
Also on the FDA's radar are compounded semaglutide products. Although the agency allows compounding pharmacies to make medications like Ozempic, the FDA issued a postmarket drug safety letter in May after receiving adverse event reports from people using compounded versions of these drugs.
The May safety letter also warned that compounders may be using salt forms of semaglutide, which are not the same active ingredients found in FDA-approved medications.
How to tell if your Ozempic is fake
According to Novo Nordisk, counterfeit Ozempic pens may have these characteristics:
- The pen will have a scale extending out from the pen when setting the dose.
- The label might be of poor quality and may not adhere to the pen.
- The carton may have spelling mistakes on the front of the box.
- A tamper-resistant/perforation may be missing from the carton.
- The batch number printed on a counterfeit box may not correspond to the product strength stated on the same box and pen.
Novo Nordisk says they've received no reports of fake Wegovy pens in the U.S. However, the company recommends visiting semaglutide.com to help determine whether a product is authentic or counterfeit.
- Novo Nordisk. Novo Nordisk warns of counterfeit Ozempic® (semaglutide injection) pen found in US.
- FDA. Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss.
- Pharmaceutical Cargo Security Coalition. Fraud Alert Pertaining to the Distribution of Ozempic, Semaglutide, and Tirzepatide.