Purchaser beware. The Meals and Drug Administration is warning individuals 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 in regards to the fakezempic final week. A number of hundred items of the counterfeits are thought to have entered the drug provide chain. It’s not clear whether or not these items 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 keeping with the alert, Novo Nordisk first notified the FDA in regards to the counterfeit medicine on April 3, which have been distributed exterior the corporate’s licensed provide chain within the U.S. The FDA says it managed to grab a few of these medicine on April 9. The merchandise might 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 accepted to deal with kind 2 diabetes. Because the approval of Novo Nordisk’s Wegovy—the next dose formulation of the identical energetic ingredient (semaglutide) accepted for weight problems— in 2021, Ozempic has turn out to be a preferred off-label remedy for weight reduction as effectively.
The FDA has obtained six antagonistic occasion stories 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 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 an analogous counterfeit drawback, with the FDA seizing hundreds of items that entered the U.S. provide chain that yr. In not less than some instances, the fake merchandise truly 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 yr, the World Well being Group sent out its own alert after being notified of counterfeit batches being offered in Brazil, the UK, and the U.S.
Then as now, the FDA is warning individuals 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.
