FDA Points Alert on Faux Ozempic—Learn how to Inform If Yours Is Actual

Purchaser beware. The Meals and Drug Administration is warning folks to be careful for shipments of counterfeit Ozempic which might be presently flooding the market.

The FDA and Ozempic producer Novo Nordisk collectively issued an alert concerning the fakezempic final week. A number of hundred models of the counterfeits are thought to have entered the drug provide chain. It’s not clear whether or not these models current a novel security danger at this level, however regardless, the FDA is telling sufferers, pharmacies, and medical doctors to not use or distribute them if recognized.

In response to the alert, Novo Nordisk first notified the FDA concerning the counterfeit medicine on April 3, which have been distributed exterior the corporate’s approved provide chain within the U.S. The FDA says it managed to grab a few of these medicine on April 9. The merchandise will be recognized by a mix of the lot quantity PAR0362 (an genuine lot) and a serial quantity beginning with the primary eight digits 51746517 (not genuine).

The counterfeits are particularly labeled as 1 milligram doses of Ozempic, which is authorised to deal with kind 2 diabetes. Because the approval of Novo Nordisk’s Wegovy—a better dose formulation of the identical lively ingredient (semaglutide) authorised for weight problems— in 2021, Ozempic has turn into a well-liked off-label medicine for weight reduction as effectively.

The FDA has obtained six antagonistic occasion reviews related to this particular lot of Ozempic (all submitted by Novo Nordisk), however none have concerned the counterfeit merchandise. Each the FDA and Novo Nordisk are testing the seized counterfeit merchandise, however they don’t but have any data on the standard, security, or id of the merchandise.

This isn’t the primary time that counterfeit Ozempic has reached the general public. In 2023, the FDA and well being companies in different international locations reported an identical counterfeit downside, with the FDA seizing 1000’s of models that entered the U.S. provide chain that 12 months. In no less than some instances, the fake merchandise really contained insulin, and several users were hospitalized with insulin overdoses consequently. The FDA additionally famous in 2023 that the needles used to inject these medicine have been counterfeit as effectively, elevating the danger of improper sterilization. Final 12 months, the World Well being Group sent out its own alert after being notified of counterfeit batches being bought in Brazil, the UK, and the U.S.

Then as now, the FDA is warning folks to not take any possibilities and to keep away from these fake merchandise.

“The company advises sufferers, wholesalers, retail pharmacies and well being care professionals to verify the Ozempic merchandise they’ve obtained and never use, distribute or promote merchandise” recognized as counterfeit, the FDA mentioned in its alert.