FDA Warning: Fake Ozempic in U.S. Supply Chain
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.
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.
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
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.
Demand for 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
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 fake Ozempic in the U.S. supply chain highlights the need for patients and doctors to be vigilant when prescribing and using the medication. It is essential to ensure that the medication is obtained from authorized distributors and to check the packaging and labeling for any signs of tampering.
FAQs
Q: What is Ozempic, and what is it used for?
A: Ozempic is a diabetes medication that is also used off-label for weight loss.
Q: How can I identify fake Ozempic?
A: Check the packaging and labeling for any signs of tampering, and ensure that the medication is obtained from authorized distributors.
Q: What are the potential risks of using fake Ozempic?
A: The potential risks include adverse reactions, ineffective treatment, and harm from unknown ingredients.
Q: How can I report suspected counterfeit Ozempic?
A: Contact the FDA or Novo Nordisk to report any suspected counterfeit products.
Q: Is it safe to use compounded versions of Ozempic?
A: Compounded versions of Ozempic are allowed by the FDA under special circumstances, but it is essential to ensure that they are obtained from authorized compounding pharmacies.
