FDA seizes ‘thousands of units’ of counterfeit Ozempic as demand surges

The U.S. Food and Drug Administration has warned patients of counterfeit Ozempic that is circulating through wholesalers, retail pharmacies and health care practitioners as Novo Nordisk’s drug remains in high demand.

The federal agency said it had seized “thousands of units” of counterfeit Ozempic and advised patients to check the product they received and throw it away if it was labeled with lot number NAR0074 and serial number 430834149057.

“Some counterfeit products may still be available for purchase,” the FDA said in a warning issued Thursday.

The FDA said five people have become ill from the products, though none of the cases are serious. The agency said the counterfeit Ozempic also claims to have the same adverse reactions as the real thing, such as nausea, vomiting, diarrhea, stomach pain and constipation.

The regulator assured that it was testing the seized products with Novo Nordisk, but “does not yet have information about the identity, quality or safety of the drugs.” The FDA said the pen label, carton, information for patients and health care professionals, and the needles that come with the injector are also counterfeit.

“The sterility of the needles cannot be confirmed, increasing the risk of infection in patients who use counterfeit products,” the FDA said.

Shares of Novo Nordisk, which are up 48% this year, were recently down 0.9%.

The U.S. Food and Drug Administration warned wholesalers, retail pharmacies, and health care practitioners about counterfeit Ozempic, noting that counterfeit semaglutide injections contained defective needles. reuters
The FDA shared this photo of the counterfeit product, which was initially created to treat type 2 diabetes but has since gained widespread popularity for its weight loss effects.

Ozempic – which is not even approved by the FDA as a weight loss solution – is initially a once-weekly shot to treat type 2 diabetes.

However, it has gained immense mainstream popularity this year for its miraculous pound-shedding effects, as evidenced by celebrities like Amy Schumer, Chelsea Handler and Tracy Morgan, and has been endorsed by Oprah, whose Weight Watchers company Recently acquired Sequence, a tele-health subscription. Service that prescribes Ozempic.

When The Post asked for comment from the Denmark-based pharmaceutical giant behind the blockbuster drug, a spokesperson pointed to a statement on its site saying it is in the “active fight against counterfeit Novo Nordisk products.”

The statement addressed adverse effects, and clarified that it is still unclear whether “these incidents involve legitimate products or counterfeit products.”

Ozempic injection contains semaglutide, a type of strong drug that mimics the actions of the GLP-1 hormone that the pancreas releases after eating to make people feel full.

Semaglutide is the same drug in Vegovy, a drug manufactured by Novo Nordisk that was initially intended to treat diabetes but was approved by the FDA in 2021 for chronic weight management.

The FDA is not the first regulator to raise concerns about so-called faux-Zempic. The Danish Medicines Agency said in a statement released on 31 October that authorities were aware of 26 websites illegally claiming to contain Ozempic and Wegovi.

According to the FDA, the injections with lot number NAR0074 and serial number 430834149057 were affected.

The European Medicines Agency also warned in October against counterfeit Ozempic pens, which the organization said incorrectly labeled the diabetes drug Ozempic with 1 mg of semaglutide for injection on labels in German.

The bizarre side effects that have emerged since Ozempic and Vegovy took effect haven’t stopped Hollywood and non-celebrities from getting prescriptions for insulin-regulated semaglutide injections — so much so that Novo Nordisk said it fears a shortage. The medicines will continue till 2024.

Adverse effects include Ozempic butt, where users are claiming their stomachs have become flattened, as well as Ozempic finger, where the size of the finger and wrist were also shrinking rapidly, leading women to fear that their engagement The rings will fall.

Among the latest and much more serious side effects patients have reported are the drugs causing thoughts of suicide and self-harm.

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Image Source : nypost.com

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