About two months ago, law authorities in West Tennessee received their first tip: a local person was selling inexpensive versions of Ozempic and other weight-loss medications.
West Tennessee Drug Task Force officials claim that because of the products’ unusually cheap cost, the tipster thought they couldn’t be real: For instance, the active ingredient in Ozempic and Wegovy, semaglutide, costs approximately $100 for a 10-milligram vial and $140 for a 15-milligram vial. The pharmaceutical company Novo Nordisk sells the brand-name versions for about $1,000 for a month’s supply.
More than 300 vials of fake semaglutide, tirzepatide, the ingredient in the weight-loss medication Zepbound, and the diabetic medication Mounjaro, along with other weight-loss medications, were discovered during a raid on Emily Arnold’s Medina, Tennessee, home last week, according to officials. Mailers, alcohol preparation supplies, syringes, and other items were also seized.
She allegedly supplied the medications to two med spa clinics in the state, according to information obtained by officials.According to investigators, some users of the fake medications complained of rashes and other discomforts from the injections.
As stated by 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.” Three shipments that were already packaged and prepared for delivery were even discovered by us.
“It was shocking,” he continued.
Arnold, 41, has been accused of 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 oversees the legal practice of compounding.In essence, a certified pharmacist makes copies of pharmaceuticals that are often recommended by a physician.
Until the scarcity of the name-brand medications is completely addressed, the FDA is permitting pharmacies 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 said that compounding pharmacies could continue producing their own versions. Online pharmacies and med spas frequently sell compounded versions of the medications because 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.
Fake GLP-1 pharmaceuticals are currently the top fraud issue that the Partnership for Safe Medicines, an advocacy group that monitors counterfeit drugs, is seeing in the United States and other countries, according to Shabbir Safdar, executive director of the organization.
According to Safdar, it has detonated. The amount of criminality and fraud occurring in this area at the moment is unprecedented in my years of observation. The criminals have been just as active as the market’s enthusiasm for the drugs.
According to Safdar, the packaging of fake weight-loss medications might closely resemble that of the original brands. However, he added, they can have the wrong or dangerous components, or they might have too little, too much, or no active substance at all.
According to West Tennessee law enforcement officials, testing conducted following the raid by Eli Lilly, the manufacturer of Mounjaro and Zepbound, showed that one of the samples Arnold sold was simply water, which might be hazardous if improperly sterilized.
“If you’re hurt, nobody will care,” Safdar remarked. All they want is your money.
The proliferation of counterfeit drugs
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.
The spokeswoman stated, “We have sent warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide and we keep a close eye on the internet for fraudulent or unapproved products.”
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 Ozempicfound units had been found in the US medicine supply chain, some might still be on the market.
In a statement, an Eli Lilly representative expressed the company’s satisfaction that Tennessee officials had taken action to prevent one of the dishonest individuals from selling counterfeit tirzepatide. According to the spokeswoman, Lilly has received shipments from China purporting to contain tirzepatide that are concealed inside a box of T-shirts or packed as dog food, tea, and face masks.
The representative stated that it is critical to curb the spread of fake and other harmful, unlicensed tirzepatide knockoffs.
Novo Nordisk stated that it is combating fake goods and bringing legal action against organizations that distribute fake medications.
A Novo Nordisk representative said in a statement that it is illegal to produce fake goods and introduce them into the legal U.S. supply chain, putting patients at serious danger.
The risks of counterfeit drugs
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 risks of fake medications, Andrade stated, “You never know what they are mixing them with.” The possibility exists that they may be combined with electrolytes, which could increase the risk of cardiac arrhythmias, for instance.
There is no way to verify that counterfeit medications adhere to health regulations.
“You can definitely be at risk of getting infections if you are putting a contaminated substance under your skin,” she warned. These infections are local in nature, however they may develop into systemic infections due to specific problems.
Who is most at risk of counterfeit drugs?
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 drug 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 drugs, the nature of weight loss medications makes it difficult to regulate the issue because so many individuals are eligible for them and because of their high cost.
He claimed that because so many individuals are potentially at risk, this situation differs slightly from previous instances of counterfeit medications. Additionally, customers think they ought to be easily accessible.
The best 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 medicine as prescribed and might look for other options.
“I got it because I was trying to lose those last 10 pounds,” Safdar remarked. People are searching the market for telehealth providers who will write that prescription. That’s not safe at all.
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