The first information reached law enforcement in West Tennessee about two months ago. Residents in the area were reportedly selling cheaper versions of Ozempic and other weight loss drugs.
West Tennessee Drug Task Force officials said the tipster believed the product could not be genuine because the price was so low. A 10-milligram vial of semaglutide, the active ingredient in Ozempic and Wigovy, retailed for about $100. For example, a 15 mg vial costs $140. Pharmaceutical company Novo Nordisk’s branded product sells for about $1,000 for a month’s supply.
Last week, authorities searched Emily Arnold’s home in Medina, Tennessee, and found more than 300 counterfeit vials of semaglutide and tirzepatide, ingredients in the weight loss drug Zepbound and the diabetes drug Munjaro, as well as drugs used to gain weight. They announced that they had discovered other drugs. loss. Syringes, alcohol preparations, mail and other items were also seized.
West Tennessee Narcotics Task Force
Authorities learned she was also suspected of supplying drugs to two medical spa clinics in the state. Officials said some people who used the counterfeit drugs reported rashes and other pain from the injections.
“We stumbled into a room that was set up like some kind of laboratory,” said Johnny Carter, director of the West Tennessee Drug Task Force. “We found three packages already packed and ready to use.”
“It was very shocking,” he added.
Arnold, 41, was charged with four felonies and misdemeanors, including impersonating a licensed professional, officials said. Her lawyer said she would plead not guilty.
As effective but expensive weight loss drugs grow in popularity in the United States, experts and public health officials warn that low-cost counterfeits are becoming increasingly common.
Counterfeit versions of Wegovy or Zepbound are different from synthetic weight loss drugs. Compounding is a legal practice monitored by the Food and Drug Administration. Compounded medications are essentially copies made by a licensed pharmacist and are typically prescribed by a doctor.
West Tennessee Narcotics Task Force
The FDA is allowing pharmacies to dispense combined versions of semaglutide and tirzepatide until the brand-name drug shortage is completely resolved. The FDA announced in October that compounding pharmacies could continue manufacturing their own versions of the drug after an industry group sued them, saying there was still a shortage of the drug. Combined versions of drugs tend to cost less and are popular in online pharmacies and medical spas.
On the other hand, counterfeit products are not approved. These are manufactured and packaged to look like genuine brand-name drugs, but often contain little or no actual drug.
Shabbir Safdar, executive director of the Partnership for Safe Medicine, an advocacy group that tracks counterfeit medicines, said fake GLP-1 drugs are the most common in the United States and other parts of the world that the organization is aware of. “This is the biggest fraud problem,” he said. now.
“It exploded,” Safdar said. “Over the years, I have never seen the amount of fraud and crime that is happening in this space right now. As excited as the market is for pharmaceuticals, so are the criminals.”
Safdar said packaging for counterfeit weight loss drugs can “look completely similar” to brand-name versions. At the same time, he said, they may contain the wrong or harmful ingredients, or they may contain too little, too much, or none of the active ingredient.
According to law enforcement officials in West Tennessee. What Mounjaro and Zepbound maker Eli Lilly tested after the raid One of the samples Arnold sold was just water, revealing that it could be dangerous if not properly sterilized.
“No one cares if you get hurt,” Safdar says. “They just want your money.”
The spread of counterfeit medicines
An FDA spokesperson said in a statement that the agency is aware of and investigating reports of counterfeit weight loss drugs being sold illegally in the United States.
“We closely monitor the internet for fraudulent and unapproved products and have issued warning letters to stop the distribution of illegally sold semaglutide and tirzepatide,” the spokesperson said.
The spokesperson added that FDA’s Office of Criminal Investigation will work with federal law enforcement authorities to pursue seizures, injunctions, and criminal prosecutions, as appropriate. Last year, the FDA announced that the agency had seized thousands of units of counterfeit Ozempic found in the U.S. drug supply chain, but noted that some may still be available for purchase.
An Eli Lilly spokesperson said in a statement that the company is pleased that Tennessee regulators have taken action to “stop one of the unscrupulous sellers of counterfeit tirzepatide.” Lilly received packages from China claiming to be tirzepatide packaged as dog food, tea, face masks or hidden inside T-shirt boxes, a spokesperson said.
“The proliferation of counterfeits and other unsafe and unapproved tirzepatide imitations is dangerous and must be stopped,” the spokesperson said.
Novo Nordisk said it is fighting counterfeit products and pursuing legal action against groups selling counterfeit medicines.
“Manufacturing and integrating counterfeit products into legitimate U.S. supply chains is illegal and puts patients at significant risk,” a Novo Nordisk spokesperson said in a statement.
Risks of counterfeit medicines
Dr. Daniela Hurtado Andrade, an endocrinologist at the Mayo Clinic in Jacksonville, Florida, said using counterfeit drugs can lead to dangerous complications.
“You never know what they’re mixing in,” Andrade said, outlining the dangers of counterfeit medicines. “There is a potential risk of mixing with electrolytes, which could pose a risk of causing arrhythmias, for example.”
In the case of counterfeit medicines, there is no way to know whether the medicine complies with health regulations.
“Putting contaminated material under your skin can certainly put you at risk for developing an infection,” she says. “These are local infections, but certain complications of local infections can become systemic infections.”
Who is most at risk from counterfeit medicines?
Anyone who purchases a GLP-1 drug without a prescription risks obtaining a counterfeit product.
The most vulnerable are those who don’t have adequate health insurance, don’t benefit from prescription drugs, or feel stigmatized about their weight and don’t seek medical attention. , said Timothy McKee, a professor of global health at the University of California, San Diego. Said.
Mr McKay, who studies counterfeit drugs, said the nature of weight loss drugs – the large number of people they target and their high prices – makes the problem even more difficult to control.
“This situation is a little different than previous counterfeit drug cases because there are probably so many people at risk,” he said. “And consumers believe they should be readily and conveniently available.”
Safdar, of the Partnership for Safe Medicines, said the best way for people to protect themselves is to always obtain branded products through a doctor’s prescription.
He acknowledged that others may not be eligible for the drug’s directed use and will explore alternatives.
“I’ve seen people say, ‘I was trying to lose those last 10 pounds and it paid off,'” Safdar says. “People are tapping into that market by finding telemedicine providers to write prescriptions for them. None of that is safe.”
