WHO warns against counterfeit Ozempic in Europe and the United States

 

The World Health Organization (WHO) recently reported three counterfeit batches of Ozempic that were discovered in late 2023 in Brazil, the United Kingdom, and the United States, with an unknown number of unreported cases. Counterfeits Ozempic products appeared Germany's official supply chain in October 2023. Novo Nordisk, the manufacturer has confirmed that the batches in question were not original products. The pens can be ineffective or contain harmful ingredients. Toxicology results are currently unknown.

Ozempic (not its counterfeit) contains the active substance semaglutide, which is used in the treatment of type 2 diabetes. Semaglutide (product name Wegovy) is also approved for the treatment of obesity. Both products have the same active substance and therefore Ozempic is used to reduce weight.

"Sustained high demand for semaglutide exceeds production capacity," Novo Nordisk reports. Given the market situation, it is not surprising that such products have become a target of counterfeiters. Counterfeit products easily enter other markets through importers or reimporters.

 

WHO has identified the following characteristics of counterfeit packaging:

• The batch number LP6F832 does not exist.
• The combination of batch number NAR0074 with serial number 430834149057 does not match manufacturing records.
• The batch number MP5E511 is correct, but the product is counterfeit.

 

Pharmacists in all countries should pay attention to the following criteria when dispensing medicines:

• The WHO advises against dispensing products labeled with suspicious batch numbers listed online.
• Counterfeit Ozempic pens, unlike the originals, may have a scale protruding from the pen when the user adjusts the dose.
• The label may not adhere well or at all to the pen.
• Spelling errors may be present on the front of the box.

 

Increased security in Germany

In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for secure pharmacotherapy. "In addition to the known counterfeit of the drug Ozempic 1 mg (product code: 04150153985573, serial number: 1946483405690, and batch: MP5E511), no further packets with the counterfeit serial number or counterfeits with other serial numbers have been identified," a statement reads.

The BfArM nevertheless advises pharmacists to open the secondary packaging before dispensing the drug and to check the primary packaging for authenticity. The boxes often appear genuine, but there are differences in the pens.

 

Due to the proximity of the Czech and German markets, the National Medicines Verification Organization (Národní organizace pro ověřování pravosti léčiv, NOOL) recommends that increased attention have to be paid when dispensing Ozempic and the package has not be given to the patient if a counterfeit is suspected (verification alert). Furthermore, NOOL recommends following the rules using the Alert Management System (CZAMS).

 

Source: WHO, Medscape Medical News, NOOL