Introduction to the FDA Warning
The Food and Drug Administration on Monday urged patients and doctors to check that their Ozempic prescriptions are legitimate after the agency seized several hundred units of fake versions of the diabetes drug in the U.S., NBC News reported.
The Discovery of Counterfeit Ozempic
Novo Nordisk, the maker of Ozempic and the weight loss drug Wegovy, told the FDA on April 3 that counterfeit 1-milligram injections were being distributed outside its authorized supply chain in the U.S., the agency said in a news release. That means it likely entered the market through unofficial means, like unauthorized distributors or resellers.
Details of the Seized Counterfeit Products
The FDA said it seized the counterfeit products — labeled with lot number PAR0362 and serial numbers starting with the first eight digits 51746517 — on April 9.
FDA was notified by Novo Nordisk on April 3 that several hundred units of counterfeit Ozempic (semaglutide) injection 1 mg were in the U.S. drug supply chain. (FDA)
Adverse Event Reports and Safety Concerns
The agency said it’s aware of six adverse event reports linked to the lot — however, none of them appear to be associated with the counterfeit product. The agency and Novo Nordisk are testing the fake products to identify whether they’re safe. Genuine Ozempic can come with side effects, including stomach problems, so it’s not clear whether the adverse events were caused by typical use.
The Rise of Counterfeit Ozempic
The fake versions underscore the soaring popularity and demand for the diabetes drug Ozempic, which is often used “off label” for weight loss, as well as similar GLP-1 drugs. In December 2023, the agency said it seized thousands of units of fake Ozempic and warned that some may still be available for purchase.
Compounded Versions of Ozempic
The fake products are different from compounded versions of the drug, which have also grown in popularity across the U.S. The FDA allows compounded versions that are “essentially a copy” of commercially available drugs under special circumstances such as shortages. In February, the agency said a shortage of Ozempic and Wegovy had been resolved in the U.S., effectively ending the sale of the less expensive compounded versions of the drugs.
Conclusion
The discovery of counterfeit Ozempic in the U.S. supply chain highlights the need for patients and doctors to be vigilant when prescribing and using the medication. With the rise of counterfeit products, it is essential to ensure that medications are obtained from authorized distributors to avoid potential health risks.
FAQs
- Q: What is the lot number of the seized counterfeit Ozempic products?
A: The seized counterfeit products are labeled with lot number PAR0362. - Q: How can I identify if my Ozempic prescription is legitimate?
A: Check the packaging and labeling for any signs of tampering or inconsistencies, and verify the serial numbers with the manufacturer or FDA. - Q: Are compounded versions of Ozempic safe?
A: The FDA allows compounded versions of Ozempic under special circumstances, but it is crucial to obtain them from authorized compounding pharmacies to ensure safety and efficacy. - Q: What are the potential health risks associated with counterfeit Ozempic?
A: Counterfeit medications can contain incorrect or harmful ingredients, which can lead to adverse health effects, including allergic reactions, overdose, or underdose.
