FDA issues new warning about counterfeit Ozempic

U.S. Food and Drug Administration

Here’s how to spot the fake product

The U.S. Food and Drug Administration (FDA) reports an increase in counterfeit Ozempic in the U.S. supply chain.

The diabetes drug, made by Novo Nordisk, has been in short supply for most of 2023 because so many consumers are using it to lose weight. Because of the shortage, the FDA warns that counterfeiters have stepped in with a look-alike product that may not be safe or effective.

The agency says it has seized thousands of units of the product. It advises wholesalers, retail pharmacies, health care practitioners and patients to check the products they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057. The FDA says some counterfeit products may still be on the market.

Risky needles

There may also be a risk from the needles used in the counterfeit Ozempic products. Since the needles are also counterfeit, their sterility 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 said it 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.

Novo Nordisk first issued a warning about fake Ozempic in August, saying  the counterfeit product appears to have contained another type of diabetes medication that works differently than Ozempic, and has reportedly led to adverse reactions.

According to Novo, here’s how to tell the difference between real and fake Ozempic:

Genuine

  • Genuine Novo Nordisk Ozempic pens do not extend or increase in length when setting the dose.

  • The dose dial window only shows intended doses:

    • On the pen intended to deliver 0.25/0.5 mg doses, it only shows -0-, 0.25 and 0.5 once dialed up to the intended doses

    • On the pen intended to deliver 1 mg dose, it only shows -0- and 1 mg once dialed up to the intended dose

    • On the pen intended to deliver 2 mg dose, it only shows -0- and 2 mg once dialed up to the intended dose

  • Authentic Ozempic pens are currently available in the following configurations:

    • 0.25/0.5 mg pen

    • 1 mg pen

    • 2 mg pen

  • The box containing authentic Ozempic will include 4 needles which attach directly onto the pen, except the Ozempic 0.25/0.5 mg dose carton which has 6 needles.

Counterfeit

  • A counterfeit pen may be identified based on scale extending out from the pen when setting the dose.

  • The label on a counterfeit pen could be of poor quality and may not adhere well to the pen.

  • A counterfeit carton may have spelling mistakes on the front of the box (i.e., 1 pen and 4 doses without space between ‘1’ and ‘pen’).

  • A counterfeit carton may not include the tamper resistant/perforation.

  • The batch number printed on a counterfeit box may not correspond to the product strength stated on the same box and pen.

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