Introduction
The World Health Organization (WHO), through its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, has issued an alert against falsified batches of Ozempic.
Manufactured by Novo Nordisk, Ozempic’s active ingredient, semaglutide, has been the subject of numerous falsification claims and reports of undesirable effects.
The WHO has identified the United States, Brazil, and the United Kingdom as regions where these falsified products have been detected.
These are not the only affected areas.
In December last year, the South African Health Products Regulatory Authority (SAHPRA) raised an alarm about counterfeit Ozempic products infiltrating the South African market, noting that many online pharmacies purported to have the product despite genuine ones being out of stock, suggesting these were likely falsified.
What is Ozempic?
Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) agonist that works by binding to GLP-1 receptors, resulting in decreased blood sugar levels.
It is used to manage Type 2 diabetes and lower the risk of cardiovascular events like heart attacks and strokes. Additionally, Ozempic reduces appetite, which has led to its controversial off-label use for weight loss.
RELATED: Counterfeit Medicines : 3 Ways Africa Can Win The Fight (II) (africanpharmaceuticalreview.com)
Which Batches Have Been Falsified?
The WHO defines falsified medical products as those that deliberately or fraudulently misrepresent their identity, composition, or source. In this instance, the detected batches of Ozempic meet this criterion as they were not manufactured by Novo Nordisk. This is evidenced by the labeling discrepancies: batch number LP6F832 is not recognized, the combination of batch number NAR0074 and serial number 430834149057 does not match genuine manufacturing records, and although batch number MP5E511 is legitimate, the associated product has been found to be falsified.
Reason for Alert & Impact on Health
Falsified medicines pose significant health risks, particularly for a drug like Ozempic used to manage chronic conditions. These counterfeits may lead to ineffective treatment, resulting in further complications and potentially death.
How to Identify the Falsified Ozempic Batches
The WHO urges regulatory authorities, healthcare providers, and the public to remain vigilant in detecting and withdrawing these falsified batches of Ozempic. The global health body advises confirming the batch numbers and serial numbers against those listed, examining the pen for a scale extending out when setting the dose, assessing the label quality as it might be poor and not adhere well, and checking for spelling mistakes on the front of the carton.
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