Falsified Ozempic Batches Trigger WHO Warning
This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.
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Three falsified batches of the type 2 diabetes and obesity drug Ozempic, the increasingly popular brand name of a semaglutide class of medicines, were the subject of a medical product alert issued by the World Health Organization (WHO) on June 19, 2024. WHO said the falsified semaglutides were detected in Brazil and the United Kingdom in October 2023, and in the United States in December 2023 (1).
Worldwide reports of falsified semaglutide products have been circulating since 2022 and have been observed by WHO’s Global Surveillance and Monitoring System, but WHO said confirmation of some of these reports—specifically the three batches identified—have now resulted in this first official notice being issued.
Because of their high cost, semaglutides are not currently recommended by WHO for diabetes management. These drugs’ tendency to suppress appetite has led to them being prescribed as weight loss medications in some countries (1).
“WHO advises healthcare professionals, regulatory authorities, and the public be aware of these falsified batches of medicines,” Yukiko Nakatani, MD, PhD, WHO assistant director-general for access to medicines and health products, said in a WHO press release (1). “We call on stakeholders to stop any usage of suspicious medicines and report to relevant authorities.”
According to the medical product alert, the falsified products misrepresent their identities and sources in several ways, which expose that they were not manufactured by Novo Nordisk. For one, batch number LP6F832 is not recognized; two, the combination of batch number NAR0074 and serial number 430834149057 does not correspond to legitimate manufacturing records; and three, the product with batch number MP53511 is falsified, even though the batch number is genuine (2).
These pieces of evidence are similar to those cautioned by the European Medicines Agency in October 2023, when the agency said that pre-filled, 1-mg solution pens labeled as Ozempic, and found at wholesalers throughout the UK and European Union, contained genuine information from Ozempic packs—such as batch numbers, 2D barcodes, and unique serial numbers—but that the serial numbers came up as inactive when scanned (3).
In this latest round of falsified products, WHO provided an annex of batch number labels that should not be sold, distributed, or used.
Using falsified Ozempic could result not only in the ineffective treatment of patients, but also contamination with harmful substances, the interactions of unknown or substituted ingredients, or serious and potentially life-threatening health risks because of the subcutaneous nature of the injection (2).
Other telltale signs of a falsified product include a scale extending out from the pen while setting the dose, a poor-quality label with poor adhesion, or spelling mistakes on the box, according to WHO (2).
Legitimate injectable semaglutides should always be stored in a refrigerator, and packaging and expiration dates should be checked by the consumer (1). A notification of a falsified medicine can be emailed to WHO at rapidalert@who.int.
References
- WHO. WHO Issues Warning on Falsified Medicines Used for Diabetes Treatment and Weight Loss. Press Release. June 20, 2024.
- WHO. Medical Product Alert N°2/2024: Falsified OZEMPIC (Semaglutide). Press Release. June 19, 2024.
- Haigney, S. EMA Warns About Falsified Ozempic Pens. PharmTech.com, Oct. 18, 2023.
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