Dangerous Counterfeits: The Ozempic Crisis

By Patrick Wingrove

In December, Drew, a 36-year-old man from San Antonio, Texas, drove more than 250 miles (400 km) to Mexico to buy cheap Ozempic to help him lose weight. On his way home, he checked the pens and noticed they looked unusual, so he shared photos on social media. The verdict: they were fakes.

Three people on Reddit mentioned that Drew’s product resembled insulin. “If so, it would be dangerous to use,” said one. A surge of insulin can cause a sharp drop in blood sugar, leading to dizziness, seizures, and death.

This incident highlights a larger issue in the manufacturing of highly sought-after drugs, allowing criminal organizations to circulate potentially lethal fakes through forged drug batch numbers.

Pharmaceutical companies, like Ozempic-maker Novo Nordisk, authenticate drug batches with a combination of letters and numbers printed on the packaging. This system helps track the product within a specific country.

The fake pens that Drew bought had lot number MP5B060, which was linked to a shipment of diabetes drugs intended for Egypt. Drew’s purchase in Mexico indicated something was wrong; however, he was unaware as a consumer.

The flaw, born from efforts to ensure drug traceability and safety, is worsened by inconsistent regulation by health authorities worldwide. By the time Drew purchased these fakes, they had been identified in at least ten countries from Azerbaijan to North Macedonia, according to a review of drug regulator announcements.

The World Health Organization (WHO) issued a warning in July 2023 about products with batch number MP5B060. Interpol had also warned about insulin pens being relabeled to look like Ozempic. While some countries banned these products, others did not.

In at least four countries, the fakes resulted in hospitalizations. In the U.S., Nigeria, and Iraq, counterfeit Ozempic shots looked like insulin pens. In Iraq, a man fell into a coma after using one before recovering.

Multi-Billion-Dollar Market

There is a massive demand for Ozempic, with over 890 million people suffering from obesity worldwide. The active ingredient, semaglutide, leads to an average weight loss of 15% and is part of a drug class that reduces food cravings and slows stomach emptying.

Novo’s franchise for Ozempic and Wegovy generated almost $19 billion in net sales last year. The company is working with authorities globally to combat counterfeits.

Experts believe the extensive recurrence of the same batch number suggests a global counterfeiting operation is at play. Often, when the same batches and labels appear, it indicates a unified source or network.

Criminals may access batch numbers through corrupt connections at drug manufacturing facilities or simply by purchasing the drug, copying the packaging, or using scanning technology, leading to serious challenges in fighting these crimes.

Despite a wide range of counterfeits emerging globally, stopping the spread is complicated due to high demand. Jared Davis, a former FDA agent, mentioned that pulling a whole line due to a small number of counterfeits could exacerbate legitimate shortages.

A Deadly Resemblance

Fake Ozempic contributes to a high volume of counterfeit pharmaceuticals that claim around a million lives annually, as estimated by the WHO. A 2023 report indicated suspected fake pills resulted in nearly 55,000 deaths in the U.S. alone in 2021.

Reports of Ozempic fakes have been identified in nearly 30 countries, linked to over two dozen serious harms and two deaths in the U.S. The drug can cost more than $1,000 for a month’s multi-dose pen. Drew mentioned he had heard of a cheaper price in Mexico, around $200 per pen; however, he ended up paying approximately $350.

Drew did not use the pens he purchased, did not report the buy to authorities, or hand in the product for testing.

Counterfeiting Operations

Rebadging insulin to mimic Ozempic is lucrative due to price differentials, and counterfeiters can easily adjust packaging to evade detection. The WHO’s alerts on the MP5B060 batch followed instances of severe hypoglycemia linked to counterfeit pens bought globally.

Some countries have banned the importation of drugs with counterfeit batch numbers, while others opted for visual checks over banning numbers to avoid shortages.

Counterfeits of Ozempic have surfaced more than Eli Lilly’s Mounjaro but that product’s counterfeits are increasing too. Serious complications related to fake Mounjaro have also emerged, underscoring the broader safety concerns.

Criminal organizations profit significantly from counterfeits, which may have an annual value of up to $431 billion. Identifying leaders of these supply chains presents a challenge.

In a notable case, Isis Navarro Reyes was charged in May for smuggling and selling fake Ozempic using TikTok. Determining if such cases stem from individual actors or broader criminal organizations remains complex, but evasion tactics often involve organized crime.