The European Medicines Agency (EMA) reported that the EU national authority reported that counterfeit pre-filled pens labeled with the diabetes medicine ‘Ozempic’ (semaglutide, 1 mg, solution) were found. injectable) to wholesalers in the EU and UK.
The pens, with German labels, come from wholesalers in Austria and Germany. EMA explained that the pens have batch numbers, 2D barcodes and serial numbers that are unique to genuine ‘Ozempic’ packaging. In the EU, each container of medicine has a unique 2D barcode and serial number so that it can be tracked in an EU-wide electronic system.
When counterfeit ‘Ozempic’ containers were scanned, the serial numbers appeared inactive, thus alerting operators to possible counterfeiting, the EMA reported.
The agency assures that there are differences in appearance between the counterfeit pen and the original pen. The German medicines agency has published an image of the counterfeit pen so that patients and professionals can compare it. “There is no evidence that the fake pens given to patients come from legitimate pharmacies and there are no reports of harm to patients in relation to fake medicine,” the EMA pointed out.
Suspicious offers
The matter is being investigated by the EU medicines regulatory authority and the police. The EMA assured that it is assisting the national authorities in their investigations. Wholesalers and pharmacies in the affected countries are warned of suspicious offers of ‘Ozempic’ to wholesalers. In addition, parallel distributors throughout the EU have been alerted.
Meanwhile, the German and Austrian regulatory authorities have issued declarations of non-compliance with good distribution practices to the affected wholesalers in their countries for failing to follow the required procedures, including compliance on safety measures. EMA is closely monitoring the situation and will provide updates as appropriate.
‘Ozempic’ contains the active ingredient semaglutide and is approved for the treatment of type 2 diabetes. According to the EMA, the latest fake reports come after an increase in demand for ‘Ozempic’ which has also caused shortages.
Finally, the European Medicines Agency warns that ‘Ozempic’ pens suspected of being counterfeit should not be used, as “they may have serious health consequences.”
