
WHO Issues Warning for Fake Semaglutide
Taking falsified semaglutide (Ozempic; Novo Nordisk) can lead to ineffective treatment due to incorrect dosing, contamination, and the use of unknown ingredients, the World Health Organization (WHO) is warning.
The World Health Organization (WHO) has released a
This alert pertains to 3 counterfeit batches of semaglutide medicines, specifically the Ozempic brand, which were found in Brazil and the UK in October 2023, and the US in December 2023. All 3 batches went through the regulated supply chain but were not manufactured by Novo Nordisk. The WHO Global Surveillance and Monitoring System (GSMS) has noted a rise in reports of fake semaglutide products across all regions since 2022. This marks the first official notice from WHO following the confirmation of some of these reports.
WHO said it does not recognize lot number LP6F832, which was identified in Brazil, and that lot number MP5E511 is genuine but the product itself is falsified, as identified in the UK in German packaging. The organization also said that in the US, the combination of lot number NAR0074 and serial number 430834149057 does not align with actual manufacturing records.
In the case of patients unknowingly using these fake products, WHO is advising them to seek medical advice from a health care provider. Additionally, health care professionals should report any and all adverse events, lack of effectiveness, and suspected falsification to the National Regulatory Authorities/National Pharmacovigilance Centre.
“WHO advises health care professionals, regulatory authorities, and the public to be aware of these falsified batches of medicines,” said Yukiko Nakatani, MD, PhD, assistant director-general for essential medicines and health products at WHO, in a
There are 4 ways to identify these fake batches of semaglutide.1 First, check the lot and serial numbers on the box. If these numbers match with those in the alert, do not distribute, sell, or use these products. The box may also have spelling errors on the front, with one such error including a missing space between “1” and “pen” in the quantity found at the bottom. Looking at the pen itself, fake batches may have a scale that extends out from the pen when setting the dose, and the label may appear lower quality and not adhere well to the pen.
“The use of falsified Ozempic may result in the ineffective treatment of patients due to incorrect dosage, contamination with harmful substances, or use of unknown or substituted ingredients,” the alert said. “It may pose other serious risks to health because of its subcutaneous injection administration that could be life threatening.”
This is not the first time a warning has been issued about falsified semaglutide. In
Following previous reports of patient harm, Lars Fruergaard Jørgensen, MSc, CEO of Novo Nordisk,
Due to the surging demand and limited supply, there is a growing concern over unregulated and counterfeit medicines. Novo Nordisk and authorities are testing suspicious products in affected countries.
References
- Medical product alert N°2/2024: falsified Ozempic (semaglutide). News release. WHO. June 19, 2024. Accessed June 20, 2024. https://www.who.int/news/item/19-06-2024-medical-product-alert-n-2-2024--falsified-ozempic-(semaglutide)
- WHO issues warning on falsified medicines used for diabetes treatment and weight loss. News release. WHO. June 20, 2024. Accessed June 20, 2024. https://www.who.int/news/item/20-06-2024-who-issues-warning-on-falsified-medicines-used-for-diabetes-treatment-and-weight-loss
- FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain. News release. FDA. December 21, 2023. Accessed June 20, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain
- AJMC staff. What we’re reading: crackdown on counterfeit Ozempic; ALS drug fails in clinical trial; cyberattack profit losses. AJMC. March 11, 2024. Accessed June 20, 2024. https://www.ajmc.com/view/what-we-re-reading-crackdown-on-counterfeit-ozempic-als-drug-fails-in-clinical-trial-cyberattack-profit-losses
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