“The European medicines agency EMA has been informed by national authorities that pre-filled pens falsely labeled as the diabetes medicine Ozempic* (semaglutide 1 mg, solution for injection) have been identified at wholesalers in the EU and the UK “. And the communication with which the EMA alerts patients and healthcare workers of the area. The pens, which according to the German label should have contained the drug which has become famous also because the active ingredient has proven effective for losing weight, came from wholesalers based in Austria and Germany.
AIFA alert: growing dangers for beauty and anti-diabetes products purchased online 08 September 2023
Fake Ozempic: batch numbers and barcodes
The intercepted products have unique batch numbers, 2D barcodes and serial numbers from original Ozempic packaging, the EMA informs in the notice. “Each package of medicine in the EU – explains the European regulatory body – has a unique 2D barcode and serial number so that it can be traced in an electronic system at Union level. When the packages of falsified Ozempic were scanned, but the serial numbers were found to be inactive, thus alerting operators to a potential forgery.”
The images released by the German Medicines Agency with the difference between the original packaging (top) and the counterfeit one (bottom)
The differences between the original drug and the counterfeit one
There are differences in appearance between the fake pen and the original. The German Medicines Agency published an image of the falsified version” as an example, but the EMA points out that there may also be falsified pens with other characteristics in circulation. “There is no evidence that these falsified pens were dispensed to patients by legal pharmacies and there is no are reports of harm to patients in relation to the falsified medicine”, the EMA informs. “The matter is currently under investigation by the EU medicines agencies and the police. And the EMA is assisting national authorities in their investigations. Wholesalers and pharmacies in the affected countries have been alerted to suspicious offers of Ozempic” received from some wholesalers. “And parallel distributors across the EU have been alerted.”
“Meanwhile, the German and Austrian regulatory authorities have issued declarations of non-compliance with good distribution practices to affected wholesalers in their countries” from the case of the counterfeit Ozempic pens “for not following the required procedures, including compliance with safety”, continues the EMA which is now “carefully monitoring the situation and will provide appropriate updates”.
The latest reports of falsification come in the wake of a surge in demand for Ozempic, riding on the drug’s popularity, which has also led to a shortage situation. “Further reports cannot be ruled out”, specifies the regulatory body in the text of the notice with which it alerts patients, inviting them not to use suspicious pens, because “this could lead to serious health consequences”. Anyone who has one of these pens that does not have the original characteristics is therefore invited to “immediately return them to the pharmacy and follow the advice of the national drug agency”. Another appeal is to “buy medicines online only from legal pharmacies”.
Wholesalers and pharmacies are advised “to exercise caution when purchasing Ozempic from suppliers and check the packaging in the verification system. Any suspicions should be reported immediately to the competent national authority.” Patients are also encouraged to be advised on how to identify counterfeit packaging. Health workers should also remind patients to buy medicines only in legal pharmacies and also notify the authorities in case of suspicious situations, the EMA reiterates.