On December, Drew, a 36-year-old resident of San Antonio, Texas, traveled over 250 miles to Mexico to purchase inexpensive Ozempic for weight loss. Upon returning home, he inspected the pens and noticed they appeared unusual, prompting him to share images online. The conclusion: they were counterfeit.

Several Reddit users remarked that Drew’s item resembled insulin. “If that’s the case, it could be hazardous to use,” one commenter noted. An insulin surge can drastically decrease blood sugar levels, leading to dizziness, seizures, or even death.

This situation highlights a broader issue in the production of highly desired medications, allowing criminal enterprises to distribute potentially deadly counterfeits through fake drug batch numbers.

Pharmaceutical firms like Novo Nordisk, the maker of Ozempic, verify drug batches using unique combinations of letters and numbers displayed on the packaging, which are utilized to trace the product within specific regions.

The counterfeit pens Drew purchased bore the batch, or lot, number MP5B060, making them appear legitimate. For Novo, this number indicated a shipment of diabetes medication intended for Egypt.

Drew’s decision to buy them in Mexico indicated something was amiss — a fact he wasn’t aware of as a consumer.

The underlying issue, aimed at ensuring drug traceability and safety, is worsened by inconsistent regulation from health authorities worldwide.

By the time Drew purchased his pens, counterfeits with the batch number MP5B060 had appeared in at least ten countries, from Azerbaijan to North Macedonia, as shown by a Reuters assessment of announcements from drug regulatory bodies and documents obtained through Freedom of Information Act (FOIA) requests.

The World Health Organization (WHO) issued a caution in July 2023 regarding products labeled with batch number MP5B060, while Interpol warned last year that insulin pens were being repackaged and labeled to mimic Ozempic. Some nations banned items with that number; others did not.

Mexico’s drug regulatory authority did not respond to a request for comment for this article.

In at least four countries, these counterfeit products have led to hospitalizations.

In the U.S., Nigeria, and Iraq, the fake Ozempic injections resembled insulin pens, according to Reuters’ document review and announcements from regulators. In Iraq, one individual fell into a coma after his blood sugar plummeted to half of normal levels following use, but later recovered, as reported by Reuters.

A Billion-Dollar Industry

Criminals may obtain batch numbers through corrupt links at a pharmaceutical company’s production facility, or simply by purchasing the medication and utilizing scanning technologies to replicate the packaging and inserts, explained Sam Louis, a former U.S. Department of Justice attorney focused on healthcare fraud.

With at least 890 million individuals grappling with obesity worldwide, as per WHO estimates, demand is immense. The active ingredient in Ozempic, called semaglutide, can result in an average weight loss of 15%. It belongs to a group of medications that minimize food cravings and slow stomach emptying.

Novo’s division for Ozempic and Wegovy, a semaglutide-based weight loss drug, generated nearly $19 billion in net sales in the previous year. The company stated it is collaborating with authorities in various countries to combat counterfeit products.

Anne Devaud, Novo’s head of global product security, informed Reuters that the company possibly identified a source linked to the batch number from the counterfeit Drew purchased, which it also suspects of distributing fake versions of other companies’ injectable medications.

The firm chose not to disclose further information.

The frequent appearance of the same batch number implies a potential global counterfeiting ring, suggested five anti-counterfeiting specialists and a WHO official.

“Our experience indicates that consistent batches and labeling likely point to the same individuals or several minor distributors acquiring from a larger source,” stated Rutendo.

Kuwana, who leads the WHO team focusing on incidents involving substandard and counterfeit medicines.

Falsified batch numbers and repackaged insulin are just part of the ongoing issue: criminals can hijack or steal medications from hospitals or medical facilities before putting on fake labels and packaging. Alternatively, they might just fill a vial with any liquid or create pills and place them in imitation packaging, shared a representative from Novo.

“These various potential sources, often connected to organized crime networks operating across different regions, pose significant challenges for those working to combat these crimes,” the spokesperson mentioned.

However, since the beginning of last year, at least 18 distinct batch numbers have been identified on counterfeit Ozempic pens across 14 countries, as evidenced by reports on adverse events and statements from health regulators.

The solution to this problem is complex. A legitimate Ozempic batch has a total of 280,000 pens; some countries decide to ban all products linked to a batch number after encountering fakes using it, while others refrain from doing so, arguing that withdrawing an entire batch due to a few counterfeits could worsen shortages.

Jared Davis, who previously worked as an agent with the U.S. Food and Drug Administration and Homeland Security, and now advises on counterfeiting matters at the law firm Oberheiden, noted the difficulty government agencies face in curtailing the spread of counterfeit medications when there is such a high demand.

“Most nations won’t remove an entire product line simply because one organization or a few individuals decided to run a counterfeit scam targeting a specific batch number,” Davis expressed.

A Dangerous Imitation

Counterfeit Ozempic contributes to the larger problem of fake pharmaceuticals that claim approximately a million lives annually, according to the WHO. A report from the U.S. CDC in September 2023 indicated that the use of suspected phony pills, such as Oxycontin, resulted in nearly 55,000 deaths in the U.S. alone in 2021.

Fakes of Ozempic in various forms have been detected in around 30 nations, as reported by Reuters. These counterfeit products have been associated with more than two dozen severe health incidents globally and two fatalities in the United States.

In the U.S., Ozempic can cost over $1,000 for a multi-dose pen meant to last a month. Drew mentioned he heard the drug could be purchased for less in the Mexican border town of Nuevo Progreso.

“I called a few pharmacies ahead of time to see if they had it, and they said yes, giving me prices around $200 per pen. I thought this would be great,” he explained to Reuters.

“Once I arrived, though, most pharmacies actually quoted much higher, and the one I found was the cheapest,” he added, noting that the store was also a restaurant. Drew ended up paying about $350 per pen.

Transporting medications across the border into the United States is illegal. Drew, who prefers to only use his first name, stated he didn’t utilize the pens, report the purchase to authorities, or submit the product for examination.

He admitted he couldn’t recall the name of the store he purchased from and after initially talking to Reuters, he deleted his social media post regarding the matter.

Repackaging insulin to mimic Ozempic is a highly lucrative operation. Like several insulin varieties, Ozempic is available in a blue prepackaged autoinjector. Outside the U.S., insulin can be obtained for as low as $8.81 per unit, according to a RAND Corporation report regarding global drug pricing.

Upon opening the boxes he purchased, Drew noticed that the autoinjectors had Ozempic labels, but they were slimmer and a darker shade of blue compared to those he’d previously encountered, as evidenced by his photos.

An insulin product from French manufacturer Sanofi, known as Apidra Solostar, comes in a similar prepackaged blue autoinjector with a clipped lid akin to that of Ozempic.

Sanofi confirmed awareness of misbranded Apidra pens being misrepresented as Ozempic, stating it has been collaborating with partners to safeguard patients. However, the company declined to comment on whether it has tried to distinguish its product from Novo’s.

When approached by inquiries about making Ozempic pens more distinctive, Novo responded that it is unlikely any single change would effectively prevent counterfeiting, as counterfeiters adapt quickly.

To Ban or Not to Ban

Azerbaijan was the first to report counterfeit products with batch number MP5B060 in December 2022.

The WHO issued a warning after three additional cases of severe hypoglycemia were reported involving fake Ozempic pens sharing the same Egyptian batch number: a woman in Britain who acquired her autoinjector from a beauty salon, a man in Serbia who bought his in the UAE, and a woman in Lebanon, as documented in separate reports sent by Novo Nordisk to the FDA and reviewed by Reuters.

In the United States, a 39-year-old female experienced critical hypoglycemia and needed emergency care after using what she believed to be Ozempic associated with that batch number, as noted in a U.S. FDA report. The outcome for her remains unknown.

Some countries, including Poland and Ukraine, have declared a ban on the importation and sale of drugs labeled with counterfeit batch numbers identified by international agencies. However, regulatory bodies in Britain, Finland, Ireland, and Sweden informed Reuters that they have not implemented such bans.

The health ministry of Ireland stated it found no counterfeits under the batch numbers flagged by the European Union, thus only alerted wholesalers and others to be cautious when purchasing Ozempic. It noted other preventive controls in place to block falsified packages, including scanning the barcodes on them.

In response to a FOIA request made in May, it was revealed that officials decided to concentrate on the visible differences between the pens, such as their colors and construction materials, instead of eliminating batch numbers. When asked about this decision in July, they explained that prohibiting batch numbers could potentially lead to shortages of legitimate medications.

The regulatory bodies in Britain and Ireland did not provide feedback on whether not prohibiting batch numbers might facilitate the distribution of counterfeit products.

Enormous Earnings

Reports indicate that there have been more counterfeits of Ozempic compared to those of Eli Lilly’s Mounjaro, a newer competitor. However, instances of counterfeit Mounjaro are also increasing.

A report from the U.S. FDA, reviewed by Reuters, documented the case of a 61-year-old woman in the U.S. who was admitted to the hospital with severe stomach pain and seizures after experiencing vomiting 70 times within four hours, following the use of a counterfeit version of Mounjaro sold to her in a vial by an unnamed health consultant. By early May, she was reported to be partially recovered.

Lilly has expressed serious concerns about the rise of counterfeit and unsafe or untested versions of its medication and highlighted the importance of having tools that assist users in verifying the authenticity of Lilly products.

Nonetheless, Lilly urged authorities to enhance their efforts against those distributing counterfeit drugs.

According to U.S. Homeland Security special agent Rana Saoud, sophisticated international counterfeiting networks can generate massive profits from these illicit products and are often adept at avoiding detection. The National Institutes of Health (NIH) has estimated that the overall counterfeit drug market could be worth as much as $431 billion each year, based on the insights of analysts.

Identifying the leaders behind such supply chains presents significant challenges. A woman from New York, Isis Navarro Reyes, was charged in May for smuggling counterfeit Ozempic and other weight loss drugs into the U.S., subsequently using TikTok to market these products. Attempts to contact Reyes have been unsuccessful.

“Until we have clear details, we can’t determine whether this is an isolated incident or linked to a larger criminal network,” stated Homeland’s Saoud. “However, it generally indicates an organization focused on making a profit.”

(Reported by Patrick Wingrove in New York; with additional contributions from Louise Breusch Rasmussen in Copenhagen and Anna Koper in Warsaw)