WHO Issues Global Alert on Fake Ozempic, Similar Medications

The products could create health complications such as unmanaged weight or blood glucose levels, the World Health Organization warned.

The anti-diabetic medication Ozempic (semaglutide) made by Danish pharmaceutical company Novo Nordisk, in Paris, on Feb. 23, 2023. Joel Sage/AFP via Getty Images

The World Health Organization (WHO) issued a medical alert on June 20, warning that fake versions of semaglutide products such as Ozempic have been detected worldwide.

Semaglutide is used in medications for people with type 2 diabetes to reduce their blood sugar levels. It is an active ingredient in Denmark-based Novo Nordisk’s Ozempic.

The WHO alert was issued after three batches of fake Ozempic were detected in Brazil, the UK, and the United States last year, the health agency said in a June 20 statement.

The WHO’s Global Surveillance and Monitoring System has been investigating increased reports of fake semaglutide products since 2022. The current alert is the first official notice that the organization has issued after confirming some of these reports.

“WHO advises healthcare professionals, regulatory authorities and the public be aware of these falsified batches of medicines,” Dr. Yukiko Nakatani, assistant director-general for WHO’s essential medicines and health products, said in a statement. “We call on stakeholders to stop any usage of suspicious medicines and report to relevant authorities.”

The agency warned that fake semaglutide products can harm people’s health, leading to unmanaged weight or blood glucose levels. In some cases, the products contain undeclared ingredients such as insulin that can lead to an “unpredictable range of health risks or complications.”

The WHO stated that semaglutide is not part of any treatment regime the organization recommends for managing diabetes because of the high cost of the medications.

The agency advised people to only purchase semaglutide products such as Ozempic from licensed physicians and avoid buying from unknown sources.

Novo Nordisk had warned about counterfeit products being sold in the United States last year, citing a fake Ozempic pen sold in a retail pharmacy.

The counterfeit item was found containing another type of diabetes medication called insulin glargine injection that “reportedly led to an adverse reaction,” the company said in a statement.

“Patients prescribed semaglutide injectable products, FDA-approved and marketed under the brand names Ozempic and Wegovy, should be vigilant in checking their medicine to ensure they are taking an authentic, Novo Nordisk-produced version of the authorized drug and injection device,” the statement reads.

Fake Medicines

In December 2023, the Food and Drug Administration (FDA) stated that it was investigating the presence of counterfeit Ozempic injections in the U.S. drug supply chain and had seized “thousands of units of the product.” It advised retail pharmacies, health care practitioners, and wholesalers to avoid selling Ozempic with specific lot and serial numbers.

The FDA reported five adverse events from this lot of Ozempic products. However, it stated that none of the reactions were serious.

Since the needles from the samples were also found to be counterfeit, the agency could not confirm their sterility.

In October 2023, Austrian authorities reported that several people who took fake Ozempic were admitted to the hospital.

“The reported serious side effect with hypoglycemia and seizures is an indication that the product incorrectly contained insulin instead of the active ingredient semaglutide,” the Austrian Federal Office for Safety in Health Care stated at the time.

Hypoglycemia occurs when the blood sugar level is too low.

In the same month, authorities in the UK cautioned citizens about fake Ozempic after a few people were hospitalized following their use of the counterfeit products. Some patients suffered from hypoglycemic shock and coma.

On Oct. 18, 2023, the European Medicines Agency issued an alert about fake Ozempic pens identified at wholesalers in the European Union and the UK.

Compounded Semaglutide

In January, the FDA warned about compounded versions of semaglutide being sold in the United States. Compounded versions refer to alternate variants of a drug created by third parties mixing various ingredients.

The FDA stated that it received adverse event reports from people who used compounded semaglutide.

“Compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used [in] the approved drugs, which contain the base form of semaglutide,” the agency stated.

“The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C [Federal Food, Drug, and Cosmetic Act] requirements for types of active ingredients that can be compounded.”

The FDA stated that it has only approved three semaglutide products for use in the United States: Ozempic, Wegovy, and Rybelsus.