European authorities identified counterfeit Ozempic pens at wholesalers in the EU and UK, allegedly originating from Germany and Austria.
On October 18, the European Medicines Agency (EMA) issued a statement warning healthcare professionals and consumers to be on the lookout for fake Ozempic pens, one of several semaglutide-based medications for weight loss and diabetes treatment.
The agency issued the statement after reports emerged of counterfeit Ozempic pens found at wholesalers in the European Union (EU) and the United Kingdom (UK).
The counterfeit Ozempic pens, bearing labels in the German language, are believed to have originated from wholesalers in Austria and Germany.
According to the statement, the fake Ozempic pens come complete with batch numbers, 2D barcodes, and unique serial numbers, all seemingly identical to those found on genuine Ozempic packaging.
However, during a routine barcode scan, the serial numbers were inactive on fraudulent Ozempic packs, immediately raising suspicion among operators, the EMA says.
To help identify these counterfeit products, the German medicines agency has published an image of one of the fake Ozempic pens. However, the EMA notes that counterfeit versions with varying features may also be circulating.
Currently, no evidence suggests that these counterfeit Ozempic pens have reached consumers through legitimate pharmacies, and the EMA has received no reports of harm to patients related to the fake medicine.
Nonetheless, EU medicines regulatory authorities and law enforcement agencies have initiated an investigation into the situation. The EMA has also alerted wholesalers and pharmacies in the affected countries to be aware of suspicious sales of Ozempic by wholesalers.
In addition, regulatory authorities in Germany and Austria have taken a stern stance with the wholesalers in question by issuing statements of non-compliance with good distribution practices (GDP). This non-compliance includes their alleged failure to adhere to required procedures, including security measures, which may have contributed to the distribution of fake Ozempic pens.
Until authorities rectify the situation, the EMA urges people in the EU who use Ozempic to check the patient information leaflet in genuine Ozempic packaging to determine what a genuine product looks like. The agency also suggests that people should only buy their medication through legal online or brick-and-mortar pharmacies and report any suspicious Ozempic pens to their national medicines agency.
The EMA says the circulation of fake weight loss jabs comes at a time when there is an increase in demand. As a result, the supply chain for drugs like Ozempic and Wegovy has led to a shortage. Now, people relying on the drug may be in harm's way and putting their health at risk.
- European Medicines Agency. EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens.