Patients and healthcare professionals warned of fake insulin pens

Patients and healthcare professionals are being alerted to reports of falsified insulin pens, which have been identified at wholesalers in the EU and the UK.

The European Medicines Agency (EMA) has been notified by competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution for injection) have been identified at wholesalers in the EU and the UK.

With labels in German, the pens originated from wholesalers in Austria and Germany.

The pens have batch numbers, 2D barcodes and unique serial numbers from genuine Ozempic packs.

Operators were alerted of the potential falsification when the pens’ barcodes were scanned.

According to the EMA, there is no evidence that any falsified pens have been dispensed to patients from legal pharmacies and there are no reports of harm to patients in relation to the falsified medicine. 

“The issue is currently being investigated by EU medicines regulatory authorities and the police. EMA is assisting national authorities in their investigations. Wholesalers and pharmacies in the impacted countries have been warned about the suspicious offers of Ozempic to wholesalers. In addition, parallel distributors across the EU have been alerted,” ESA commented.

“In the meantime, the German and Austrian regulatory authorities have issued statements of non-compliance with good distribution practices (GDP) to the concerned wholesalers in their countries for not following required procedures, including compliance with security measures. EMA is monitoring the situation closely and will provide updates as appropriate.”

According to the organisation, the latest reports of falsification come in the wake of an increase in demand for Ozempic pens, which has led to a shortage situation.