WHO warns against Ozempic fraud in Europe and USA

Ozempic synthetic products appeared in a German warehouse in October 2023, as reported by Medscape Medical News. Recently, the World Health Organization (WHO) reported on three other synthetic Ozempic groups that were found at the end of 2023 in Brazil, the United Kingdom, and the United States, with an unknown number of unreported cases.

Manufacturer Novo Nordisk has confirmed that the batches in question are not original products. Pens may not work or contain harmful ingredients. Toxicology results are currently unknown. Such counterfeit products easily enter additional markets through drug dealers or exporters.

Supply Shortage

Semaglutide is approved for the treatment of type 2 diabetes (Ozempic) or obesity (Wegovy), and Ozempic is used off-label for obesity. Considering the state of the market, it is not surprising that such products have become the target of counterfeiters.

“Sustained high demand for Ozempic exceeds production capacity,” wrote Novo Nordisc. “To ensure the supply of Ozempic 1 mg, especially to people who are already being treated with Ozempic for type 2 diabetes, the focus is on providing Ozempic 1 mg in agreement with the authorities.”

Therefore, in the second half of 2024, the starting dose of Ozempic 0.25 mg will not be given, and Ozempic 0.5 mg will be given with restrictions. In other words, the product cannot be introduced to new patients. To reduce side effects, the first subcutaneous dose of 0.5 mg is administered weekly and eventually increased to 1 mg weekly.

Identifying Artificial Products

Yukiko Nakatani, MD, PhD, WHO deputy director-general for access to medicines and health products, advises doctors and pharmacists to be especially careful with these products. WHO has identified the following characteristics of artificial packaging:

• Batch number LP6F832 is missing.
• The combination of batch number NAR0074 and serial number 430834149057 does not match production records.
• The batch number MP5E511 is correct, but the product is counterfeit.

Businesses in all countries should observe the following practices when dispensing medicines:

• WHO advises against offering products labeled with dubious numbers listed on the internet.
• Ozempic synthetic pens, unlike the original, may have a scale that protrudes from the pen when the user adjusts the measurement.
• The label may not adhere well or at all to the pen.
• Spelling errors may occur on the front of the box.

Enhanced Security in Germany

In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for safe medical treatment. “In addition to what is known as a fake drug Ozempic 1 mg (product code: 04150153985573, serial number: 1946483405690, and batch: MP5E511), there are no other packages with a counterfeit or fake serial number which have other serial numbers.

However BfArM advises entrepreneurs to open the second package before dispensing the medicine and check the original package for authenticity. The boxes usually look real, but there is a difference between the pens.

In addition, in Germany, the securPharm system is available as another effective tool for detecting counterfeit drugs. Manufactured in accordance with the European Union (EU) Falsified Medicines Directive (2011/62/EU).

Each drug package receives a unique serial number, product code, batch number, and expiration date in the form of a Data Matrix code on the package before it is delivered to the factory. Manufacturers enter serial numbers and other product information into a database managed by securPharm. Throughout the supply chain (for example, in multiple stores or pharmacies), employees check the package and verify the code. If the serial number has already been used or is missing from the database, the software issues a warning, and the medication will not be dispensed.

In addition to the Data Matrix code, the package has invisible seals to ensure that the package is not opened unattended.

This story is translated from Medscape German Edition using several editing tools, including AI, as part of the process. Human editors have reviewed this content before publication.