FDA Points Alert on Pretend Ozempic—Learn how to...

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

The FDA and Ozempic producer Novo Nordisk collectively issued an alert in regards to 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 singular security threat 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 in regards to the counterfeit medicine on April 3, which had been distributed outdoors 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 could 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 permitted to deal with kind 2 diabetes. For the reason that approval of Novo Nordisk’s Wegovy—a better dose formulation of the identical energetic ingredient (semaglutide) permitted for weight problems— in 2021, Ozempic has grow to be a preferred off-label remedy for weight reduction as properly.

The FDA has obtained six hostile occasion experiences linked 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 identification 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 nations reported the same 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 truly contained insulin, and several users were hospitalized with insulin overdoses because of this. The FDA additionally famous in 2023 that the needles used to inject these medicine had been counterfeit as properly, elevating the chance 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 steer clear of these fake merchandise.

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