About two months ago, police officials in West Tennessee received their first tip: a local person was selling inexpensive versions of Ozempic and other medications used for weight reduction.
West Tennessee Drug Task Force authorities claim that because of the items’ relatively cheap cost, the tipster thought they couldn’t be real: For instance, the active component in Ozempic and Wegovy, semaglutide, costs around $100 for a 10-milligram vial and $140 for a 15-milligram vial. A month’s supply of the brand-name versions, which are produced by Novo Nordisk, cost about $1,000.
When authorities raided Emily Arnold’s Medina, Tennessee, home last week, they reportedly discovered over 300 vials of fake semaglutide and tirzepatide, which are ingredients in the weight-loss medication Zepbound and the diabetic medication Mounjaro, as well as other weight-loss medications. Mailers, alcohol preparation supplies, syringes, and other items were also seized.
She reportedly supplied the medications to two med spa clinics in the state, according to information obtained by officials. According to investigators, several users of the fake medications complained of rashes and other discomforts following the injections.
According to Johnie Carter, the director of the West Tennessee Drug Task Force, “we stumbled into one room that was set up, sort of like a lab.” “We even discovered three packages that were prepared and ready to be shipped.”
Arnold, 41, has been accused with four crimes and one misdemeanor, including impersonating a certified professional, according to officials. According to her lawyer, she will enter a not guilty plea.
Experts and public health officials caution that low-cost counterfeit versions of weight reduction medications are becoming more prevalent as the expensive but highly effective medications gain popularity in the United States.
Compound weight loss medications are not the same as counterfeit copies of Wegovy or Zepbound. The Food and Drug Administration keeps an eye on the legal activity of compounding. In essence, compounded drugs are duplicates created by a certified pharmacist and typically recommended by a physician.
Until the scarcity of the name-brand medications is completely addressed, the FDA is permitting pharmacists to prescribe compounded forms of tirzepatide and semaglutide.
After a compounding trade organization sued the FDA in October, claiming that the medications were still in low supply, the FDA stated compounding pharmacies may continue producing their own versions. Online pharmacies and med spas frequently sell compounded versions of the medications since they are typically less expensive.
Conversely, counterfeits lack a license. Although they are produced and marketed to resemble genuine brand-name drugs, they frequently contain little or no active ingredient.
False GLP-1 pharmaceuticals are “the No. 1 fraud issue” that the Partnership for Safe Medicines, an advocacy group that monitors counterfeit drugs, is now witnessing in the United States and other countries, according to Shabbir Safdar, executive director of the organization.
Safdar exclaimed, “It has exploded.” The amount of criminality and fraud occurring in this area at the moment is unprecedented in my years of observation. Criminal activity has kept pace with the market’s enthusiasm for the medications.
According to Safdar, the packaging of fake weight reduction medications might “look like a perfect look-alike” to the name-brand ones. However, he added, they can have the incorrect or dangerous components, or they might have too little, too much, or no active substance at all.
Following the search, Eli Lilly, the company that makes Mounjaro and Zepbound, tested one of the samples that Arnold sold and found it to be nothing more than water, which might be hazardous if not properly sterilized, according to West Tennessee law enforcement officials. “If you’re hurt, nobody will care,” Safdar declared. “All they want is your money.”
The spread of fake medications
According to a statement from an FDA spokeswoman, the agency is aware of and looking into claims of fake weight-loss medications being sold illegally in the United States.
“We have issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide, and we diligently monitor the internet for fraudulent or unapproved products,” the spokeswoman stated.
The FDA’s Office of Criminal Investigations will collaborate with federal law enforcement authorities to continue seizures, injunctions, and criminal prosecutions if necessary, the spokeswoman continued. Although the FDA stated last year that thousands of counterfeit Ozempic units had been recovered from the U.S. medicine supply chain, some could still be on the market.
In a statement, an Eli Lilly representative expressed the company’s satisfaction with the Tennessee regulators’ efforts to “stop one of the bad actors selling knockoff tirzepatide.” According to the spokeswoman, Lilly has received shipments from China purporting to contain tirzepatide that are concealed within a box of T-shirts or packed as dog food, tea, and face masks.
“It is imperative to curb the spread of fake and other dangerous, unapproved tirzepatide knockoffs,” the representative stated.
Novo Nordisk stated that it is battling fake goods and bringing legal action against companies who distribute fake medications.
A Novo Nordisk representative stated in a statement that it is unlawful to produce fake goods and introduce them into the legal U.S. supply chain, putting patients at serious danger.
The dangers of fake medications
According to Dr. Daniela Hurtado Andrade, an endocrinologist at the Mayo Clinic in Jacksonville, Florida, using a fake drug can result in harmful side effects.
Speaking broadly about the perils of fake medications, Andrade stated, “You never know what they are mixing them with.” “There is a chance that they are combined with electrolytes, which could increase the risk of cardiac arrhythmias, for instance.”
There is no way to verify if counterfeit medications adhere to health requirements.
“You can definitely be at risk of getting infections if you are putting a contaminated substance under your skin,” she stated. “These are local infections, but there is a chance that some of their complications could develop into systemic infections.”
Who is most vulnerable to fake medications?
Anyone purchasing a GLP-1 medication without a prescription runs the danger of receiving a fake one.
Timothy Mackey, a professor of global health at the University of California, San Diego, stated that those who lack prescription medication benefits or proper health care coverage, or who feel stigmatized by their weight and refuse to see a doctor, are the most at risk.
According to Mackay, who investigates counterfeit pharmaceuticals, the characteristics of weight reduction medications—many individuals qualify for them and they are expensive—make the issue increasingly harder to manage.
“There are probably a lot more people at risk in this case than in previous instances of counterfeit medications,” he stated. “And customers feel that they ought to be easily accessible.”
The greatest defense, according to Safdar of the Partnership for Safe Medicines, is to always obtain the brand-name medication with a prescription from a physician.
He admitted that some patients might not be able to utilize the medication as prescribed and might look for other options.
‘I got it because I was trying to lose that final 10 pounds,’ I’ve seen people say,’ Safdar added. After locating telehealth providers who can write that prescription, people are experimenting with the market. That’s not safe at all.
