The European Medicines Agency (EMA) has reported that EU national authorities have notified that Fake labeled pre-filled pens have been detected like medicine for diabetes ‘Ozempic‘ (semaglutide, 1 mg, solution for injection) at wholesalers in the EU and UK. According to the EMA, the latest reports of counterfeiting come after an increase in demand for the drug – widely used especially for its effectiveness in losing weight – which has also caused a shortage situation.
The pens, with labels in German, came from wholesalers in Austria and Germany. The EMA has explained that the pens have lot numbers, barcodes 2D and unique serial numbers from authentic ‘Ozempic’ packaging. In the EU, each medicine container carries a unique 2D barcode and serial number so that it can be tracked in an EU-wide electronic system.
When the counterfeit ‘Ozempic’ containers were scanned, the serial numbers appeared inactive, alerting operators to a possible falsificationreport from the EMA.
The agency has assured 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 them. “There is no evidence that counterfeit pens have been dispensed to patients from legal pharmacies and there are no reports of harm to patients in relation to the counterfeit medicine,” the EMA points out.
The matter is being investigated by EU medicines regulatory authorities and police. The EMA has assured that is assisting national authorities in their investigations. Wholesalers and pharmacies in the affected countries have been warned of suspicious offers of ‘Ozempic’ to wholesalers. In addition, parallel distributors throughout the EU have been alerted.
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Meanwhile, German and Austrian regulatory authorities have issued statements of failure to comply with good distribution practices to affected wholesalers in their countries for not following required procedures, including compliance with safety measures. The EMA is closely monitoring the situation and will provide updates as appropriate.
‘Ozempic’ contains the active substance semaglutide and is approved for the treatment of type 2 diabetes. Lastly, the European Medicines Agency warns against using ‘Ozempic’ pens that are suspected of having been falsified, since “it could have serious consequences for health.