Ozempic Falsifications: BfArM starts Investigation

Recommendation

23/24 October 2024

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Requirements, Challenges & Solutions

The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. This means that the lead now no longer lies with the state authorities concerned. In the case of the drug Ozempic® from the pharmaceutical manufacturer Novo Nordisk A/S, counterfeits had been identified at the wholesale level in packages of the strength 1 mg in German presentation. At present, it cannot be ruled out that other packages with other strengths may also be affected.

Current Measures

Ozempic® is approved in Germany as a diabetes drug. However, it is also used "off-label" to lose weight. Due to the potential significant health risk posed by the counterfeits, affected packages must not be used. So far, counterfeits have been identified at the wholesale level for 1 mg strength packs of two batches. As these are two original batches of the medicinal product, not all packages of the batches are affected. However, at present, it cannot be ruled out that other packages with a different batch number and serial number or with a different potency may be affected.

The BfArM advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care. Packages that trigger an alarm in the securPharm system, which was originally introduced to protect against falsified medicines, or are conspicuous in any other way must not be dispensed. They must be quarantined immediately and the responsible competent authorities must be informed.

From the outer packaging of the drug it is difficult or impossible to distinguish the fake from the original. However, the counterfeit can be easily recognized visually from the primary packaging (pictures are provided on the BfArM website). All pharmacies are therefore urged, until further notice, to open all packages before dispensing and to compare the primary packaging with the photos provided.

The investigations into this case are ongoing and the police authorities have been informed. The BfArM continues to be in close contact with the state authorities responsible for monitoring the movement of medicinal products in Germany and with the authorities abroad as well as with the European Medicines Agency (EMA).