With the weight loss drug industry expected to be worth $100 billion by 2030, coupled with the ongoing supply crisis, time-consuming production processes, high prices, and the lack of generic alternatives, it's no surprise that injectable weight loss pills are a prime target for the counterfeit drug trade. Several people in Austria have reportedly been hospitalized for using counterfeit Ozempic (simaglutide) obtained from doctors, and now international authorities and pharmaceutical companies have issued new warnings against counterfeit medicines.
The patients developed serious health problems, including hypoglycemic shock and coma, leading the UK Medicines and Healthcare products Regulatory Agency (MHRA) to believe that the counterfeit drug contained insulin instead of Ozempic's active ingredient, simaglutide.
"We advise all members of the public not to use any pre-filled slimming pens they may have purchased online and instead report them to us so that we can investigate and take any necessary action," the MHRA said in a statement. "
Since January 2023, the MHRA has seized 369 Ozempic pens that are believed to be counterfeit. There have been no reports of counterfeit medicines before this year, but authorities are predicting an increase in the illegal trade.
Will Quince, the UK health secretary, said: "No one should put profit ahead of the needs of patients, but fraudsters selling black market medicines like this are extremely dangerous and can endanger people's health." The medical advice is clear: patients should only use medicines such as Ozempic or Saxenda if they are prescribed by a legitimate source, such as a GP or other legal prescriber. We fully support the MHRA in its fight against these illegal online providers to ensure that patients are protected. "
Marcaglutide belongs to the glucagon-like peptide-1 (GLP-1) receptor agonist class of drugs, which was initially used to treat diabetes but is now increasingly used for weight loss. The two brands of drugs currently on the market – Ozempic and Wegovy – are manufactured by the Danish company Novo Nordisk and have been in a global supply shortage for most of 2023. Novo Nordisk also produces a similar GLP-1 drug, liraglutide, which is sold in the UK as a weight loss drug, Saxenda.
A third drug, tizaparatide (marketed by Eli Lilly and Company under the name Mounjaro) has been on the market since 2022 for the treatment of type 2 diabetes, but there has also been a severe supply shortage after it was recently approved for weight loss prescriptions. It activates the same hormone receptor as Ozempic as well as another related receptor. (Triple agonists that activate three receptors are under development).
Compounding the supply problem is the production process of the drug. Ozempic requires specialized equipment and a unique environment, so scalability beyond existing measures is not straightforward.
"Buying products like Ozempic or Saxenda from suppliers who trade illegally without a prescription greatly increases the risk of receiving counterfeit medicines or using them without a license," said Dr. Alison Cave, MHRA's Chief Safety Officer. "
The German Federal Institute for Medicines and Medical Devices (BfArM) has also stepped up its investigation and issued a new warning after the discovery of a 1mg Ozempic pen in a German package at the wholesale link.
In a statement, BfArM indicated the serial number of the counterfeit product. "However, the possibility of counterfeit drugs entering the legal sales chain in Germany cannot be ruled out. It is difficult or impossible to distinguish a drug from the original product on the outer packaging, however, a counterfeit drug can be easily and visually identified from the main packaging."
The German Federal Institute for Medicines and Medical Devices has issued a warning about counterfeit pens and has included this comparison image in its public service message
As a result, pharmacies must open all boxes and inspect them before they can dispense prescription drugs to patients.
In the United States, drug shortages and high prices have discouraged many consumers, leading to the prevalence of so-called compound simaglutide, which is sold through compound pharmacies.
Combination drugs are mixed, combined, or altered in composition to tailor the drug to the patient's different needs, such as removing an allergen from a FDA-approved drug or changing its form (liquid instead of tablet). About 1-3% of prescription drugs are combination formulations.
Combination formulations can keep the supply chain of certain drugs running when demand is insufficient, but semaglutide is not approved to change in this way.
"Patients should be aware that some products marketed under the name 'semaglutide' may not contain the same active ingredient as FDA-approved semaglutide products, and may instead be salt formulations," the FDA said in June. Products containing these salts, such as sodium simaglutide and marmaglutide acetate, have not been proven to be safe and effective. "
"Purchasing medicines online from unregulated, unlicensed sources may expose patients to potentially unsafe products that have not been properly evaluated or approved or do not meet quality standards," the FDA said. If you choose to use an online pharmacy, the FDA's BeSafeRx campaign resources and tools can help you make safer, more informed decisions when purchasing prescription drugs online. "
In June and July, Novo Nordisk launched a series of lawsuits against compound pharmacies and "health" centers for using their product trademarks on drugs that have not been approved by the FDA.
Doug Langa, Executive Vice President and President of North American Operations at Novo Nordisk, said, "These actions directly reflect our priority to ensure that patients have safe and aggressive access to our FDA-approved semaglutide drug. We believe it is important to provide more tools and education to support the proper use of our approved products and to provide a broad public awareness of the differences between our FDA-approved drugs and other products labeled as simaglutide. "
At the same time, Eli Lilly, the maker of Mounjaro, followed suit in September, taking action to "protect patient safety and stop medical spas, wellness centers, and drug pharmacies from illegally marketing and selling non-FDA-approved combination products that falsely claim to be Mounjaro (teizepatide)."
All cases are still pending.
In the last quarter of 2022, Ozempic had more than 9 million prescriptions. Novo Nordisk is currently the most profitable company in Denmark and expects profits to grow by 40%-46% this year in the latest financial figures to be released.