Friday, December 22, 2023

FDA: "FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain"

 Via FDA's website: 

FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured below. Some counterfeit products may still be available for purchase.

FDA and Novo Nordisk (manufacturer of Ozempic) are testing the seized products and do not yet have information about the drugs’ identity, quality, or safety.

Additionally, analysis found the needles from the samples are counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton. 

FDA is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain and constipation.

It seems to me that this sort of thing is to be expected with such a revolutionary drug. It seems to me that the only thing that Novo could have done was to ensure a plentiful supply of Ozempic from the start, but I'm not sure there was enough fill-and-finish capacity available, especially with them surely competing with every vaccine manufacturer for available lines... 

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