WHO Warns of Counterfeit Ozempic in the Global Supply Chain—Here’s What to Know

https://jamanetwork.com/journals/jama/fullarticle/2821502

The World Health Organization (WHO) is warning of counterfeit Ozempic discovered in 2023 in regulated supply chains in Brazil, the UK, and the US, amid an uptick in similar reports worldwide. Besides potentially being ineffective, fake versions of the drug pose a serious, perhaps life-threatening risk because they are injected under the skin, according to the alert.

Ozempic, a branded version of the drug semaglutide, is a once-weekly injection to treat type 2 diabetes and cardiovascular disease; it’s also prescribed for weight management off-label or at a different dose under the brand name Wegovy. Demand for these hugely popular glucagon-like peptide 1 (GLP-1) receptor agonists has often exceeded supply—at least 25 000 patients are starting Wegovy every week in the US, according to drug maker Novo Nordisk—and earlier this year, the WHO linked shortages of drugs like Ozempic to a rise in counterfeit versions sold though unregulated outlets including social media platforms.

The recent WHO warning is the first public alert to verify falsified Ozempic’s infiltration into legitimate drug supply chains in 3 different countries. It asks health care professionals, regulatory authorities, and the public worldwide to be on the lookout for suspicious medicines and to report any irregularities.

“WHO has received reports of falsified Ozempic detected in at least 14 countries across 4 different WHO regions,” Rutendo Kuwana wrote in an email to JAMA Medical News. Kuwana is the team lead for substandard and falsified medical products at WHO, which has been actively monitoring and responding to reports of counterfeit Ozempic since September 2022. WHO does not know how many people were affected or how many units were counterfeit in Brazil, the UK, or the US, he said.

According to Kuwana, no serious or uncommon adverse reactions were noted in the incidents reported to WHO. “WHO is however aware of media reports of adverse effects, especially when the incorrect active substance is used,” he added.

“Counterfeit drugs are illegal, and they could contain the wrong ingredients, other harmful ingredients, or contain too little, too much or no active ingredient at all,” Sangeeta Chatterjee, PharmD, deputy director of the US Food and Drug Administration (FDA) Office of Drug Security, Integrity, and Response, wrote in an email.

The WHO’s medical alert is a roundup and verification of previously reported fakes, which Ozempic manufacturer Novo Nordisk confirmed were falsified.

In December, the FDA reported:

• Thousands of units of counterfeit Ozempic (1 mg) with serial number 430834149057, lot NAR0074—a combination that does not correspond to genuine manufacturing records

• Needles from the lot were also counterfeit and of unknown sterility and read “NovoFine” rather than the authentic “NovoFine Plus.”

• Packaging and prescribing information were also falsified.

• Some of these counterfeit products may still have been available for purchase in December 2023.

 

In October, the UK Medicines and Healthcare products Regulatory Agency (MHRA) reported:

• Counterfeit prefilled Ozempic pens (1 mg) identified at 2 UK wholesalers that were bought from legitimate suppliers in Austria and Germany.

• Batch number MP5E511 of the pens is genuine but the product is counterfeit.

• Dose selectors protrude beyond the counterfeit pens when setting doses, unlike authentic Ozempic pens.

• None of the falsified pens were dispensed to patients, and there were no reports of harm.

 

Also, in October, Novo Nordisk informed Brazil’s national health surveillance agency about counterfeit Ozempic batch number LP6F832.

In the US, the regulated supply chain for drugs starts with a manufacturer like Novo Nordisk, and includes repackagers, wholesale distributors, third-party logistic providers, and pharmacies.

“The US has a very safe drug market, but it’s not unheard of that [counterfeits] happen,” said Kristina Acri, PhD, an economist at Colorado College who studies counterfeit medications.

A buyer at a midsize pharmaceutical distributor warehouse in New York purportedly found the fake batch, according to a Vanity Fair article, and the New York Times quoted a Novo Nordisk representative who said the falsified products were found in warehouses outside the company’s authorized supply chain. The FDA recommends that pharmacies only buy Ozempic through distributors authorized by Novo Nordisk.

As of March 2024, the FDA is aware of 9 adverse event reports for products with the lot number of the counterfeit Ozempic, Chatterjee wrote.

“The agency continues to monitor adverse event reports through MedWatch. However, we are not able to provide additional details about an ongoing investigation,” Chatterjee wrote in response to a request for information about the counterfeit products’ quality and safety and how they came into the legitimate supply chain.

The UK has a similarly regulated drug market to the US, Acri said, adding that some developing countries with less sophisticated markets can present more opportunities for counterfeit drugs to slip in.

“Producing counterfeit drugs and inserting them into the legitimate supply chain is an illegal activity and puts patients at considerable risk,” a spokesperson for Novo Nordisk said in an email.

In June 2023, Novo Nordisk reported that a counterfeit Ozempic pen, reportedly bought at a retail pharmacy in the US, actually contained insulin and led to an adverse reaction.

Novo Nordisk has filed 21 lawsuits as of May 2024 against businesses such as medical spas, weight loss clinics, and pharmacies selling compounded versions of semaglutide that could be harmful and deceptively marketed. A compounded version of a drug may be allowed when a commercially available drug appears on the FDA’s drug shortage list. Compounded drugs are not approved by the FDA, and the agency cannot verify their safety or effectiveness. Novo Nordisk said it does not directly or indirectly sell bulk semaglutide to compounding pharmacies.

A search of the FDA’s site showed that between last October and early July of this year, the agency sent warning letters to 6 online retailers selling unapproved or misbranded semaglutide or tirzepatide. The latter is a GLP-1 and glucose-dependent insulinotropic polypeptide agonist drug that works similarly to semaglutide to suppress appetite and delay gastric emptying. It’s sold by Lilly under the name Mounjaro for diabetes and as Zepbound for weight management.

Lilly has filed lawsuits against business purporting to sell products containing tirzepatide and in an open letter said it “is deeply concerned about the proliferation of online sales and posts on social media involving counterfeit, fake, compounded, and any other unsafe or untested versions of what they say is tirzepatide.”

John Buse, MD, PhD, a professor of medicine at University of North Carolina School of Medicine, said his patients with diabetes and obesity continue to intermittently struggle to fill prescriptions for semaglutide and tirzaptide, often calling dozens of pharmacies to find inventory. “It is driving doctors and patients crazy.”

Wegovy, Mounjaro, and Zepbound continue to be in short supply, according to the FDA. These shortages coupled with increasing demand has fueled the market for counterfeit Ozempic, Acri noted.

“It comes down to economics,” she said. “There is a tremendous amount of money that can be made in making and passing along counterfeit drugs, and that’s a great incentive for some really evil people.”

In addition to fighting counterfeits, drug manufacturers are trying to relieve shortages fueling the market for fakes. In late June, Novo Nordisk announced it plans to invest $4.1 billion in a North Carolina manufacturing facility to expand production of its obesity drugs and other medications, but the construction is not expected to be complete until between 2027 and 2029.

To avoid purchasing falsified medications, the FDA recommends that consumers only buy Ozempic from state-licensed pharmacies that require a valid prescription and that they check the packaging for signs of counterfeiting. Clinicians and consumers should report adverse effects to FDA’s MedWatch program by submitting an online report or downloading a report that they can fax to 1-800-FDA-0178.

Acri and Buse said consumers may never know if they used a counterfeit version of a drug unless they have an adverse reaction.

Buse said, “If someone is good at creating counterfeit material, unfortunately, I think it’s going to be very difficult for patients and pharmacists to know when they might have these bootleg products.”

 

Filed under: General Problems