The injectable drug Ozempic is proven in Houston on July 1, 2023.
David J. Phillip/AP
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David J. Phillip/AP
The Meals and Drug Administration is warning individuals to be looking out for counterfeit Ozempic, the diabetes drug that many individuals use off-label for weight reduction.
The federal company and Novo Nordisk, the Danish pharmaceutical big that makes Ozempic, said this week that that they had discovered about “a number of hundred models” of the drug that made it onto the market outdoors of the corporate’s authorized provide chain.
Ozempic, made by Novo Nordisk, is a part of a category of medication often known as GLP-1 agonists. The medication are used to deal with sort 2 diabetes and weight problems.
The FDA stated it was notified by Novo Nordisk in regards to the counterfeit medication on April 3 and that it seized the recognized merchandise on April 9.
Nonetheless, each the company and the corporate urged customers, sellers and medical professionals to double-check their Ozempic available. The counterfeit merchandise have each the lot quantity PAR0362 and a serial quantity beginning with 51746517. The lot quantity is genuine, however the serial numbers should not, the corporate stated.
The Meals and Drug Administration is warning to not distribute, use or promote Ozempic merchandise labeled with lot quantity PAR0362 and serial quantity beginning with the primary eight digits 51746517.
The Meals and Drug Administration
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The Meals and Drug Administration
Novo Nordisk reported six antagonistic occasions associated to this lot of remedy, which included each genuine and counterfeit doses. The antagonistic occasions seem like related to genuine Ozempic, and the unwanted effects had been these you may usually see with the drug, in line with an organization spokesperson, although they didn’t element the particular unwanted effects skilled in these circumstances.
This is not the primary public warning about counterfeit Ozempic. In 2023, the FDA alerted the public to hundreds of counterfeit doses that had gotten into circulation.
A spokesperson for Novo Nordisk declined to remark Wednesday on the place the counterfeit medication originated and whether or not they had been associated to the 2023 warning. The FDA didn’t reply to a request for remark.
Dave Moore, Govt Vice President of Novo Nordisk’s U.S. Operations, stated in a press release that the corporate is taking the “rising variety of incidents involving counterfeit variations of Ozempic” critically.
“It’s gravely regarding, and we do all we will to alert sufferers, healthcare professionals, wholesalers, and retail pharmacies, about counterfeit incidents once they come up,” Moore stated in a press release.
Novo Nordisk said Monday that an investigation of the counterfeit Ozempic models, together with chemical testing, was underway.
“Accordingly, neither Novo Nordisk nor FDA can verify the contents or high quality of the counterfeit product, which can current a security threat for sufferers who use the counterfeit product,” the corporate stated in a press launch.
The FDA stated Monday that it and Novo Nordisk had been testing the seized merchandise however “don’t but have details about the id, high quality or security of those medication.”
Novo Nordisk instructed sufferers to not use any Ozempic with the corresponding lot and serial numbers, and it inspired retail pharmacies to solely buy the drug from the corporate’s approved distributors.
