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.
Shabbir Safdar, the executive director of the Partnership for Safe Medicines, an advocacy group that tracks counterfeit drugs, said fake GLP-1 medications are the No. 1 fraud issue that group is seeing in the U.S. and other parts of the world right now.
According to Safdar, it has detonated. I ve never seen the quantity of fraud and crime that is happening in this space right now in anything for years. The criminals have been as active as the market excitement about the medicines are.
The packaging of the counterfeit weight loss drugs can appear like a perfect look-alike to the brand-name versions, Safdar said. At the same time, he said, they could contain wrong or harmful ingredients, or contain too little, too much or no active ingredient at all.
West Tennessee law enforcement officials saidthat testing by Eli Lilly, the maker of Mounjaro and Zepbound, after the raidrevealed that one of the samples sold by Arnold was nothing more than water, which could be dangerous if not properly sterilized.
“If you’re hurt, nobody will care,” Safdar remarked. They just want your money.
The proliferation of counterfeit drugs
The FDA is aware of and investigating reports of counterfeit weight loss drugs being illegally marketed in the U.S., an agency spokesperson said in a statement.
We vigilantly monitor the internet for fraudulent or unapproved products and have issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide, the spokesperson said.
If needed, the spokesperson added, the FDA s Office of Criminal Investigations will work with federal law enforcement officials to carry on seizures, injunctions and criminal prosecutions. Last year, the FDA announced that officials hadseized thousands of units of counterfeit Ozempicfound 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 was pleased that regulators in Tennessee took action to stop one of the bad actors selling knockoff tirzepatide. Lilly has obtained shipments from China claiming to be tirzepatide that are packaged as dog food, tea and facial masks or hidden inside of a box of T-shirts, the spokesperson said.
The proliferation of counterfeit and other unsafe, unapproved tirzepatide knockoffs is dangerous and needs to be stopped, the spokesperson said.
Novo Nordisk said it s fighting counterfeit products and pursuing litigation against groups that sell counterfeit drugs.
Producing counterfeit products and inserting them into the legitimate U.S. supply chain is an illegal activity and puts patients at considerable risk, a Novo Nordisk spokesperson said in a statement.
The risks of counterfeit drugs
Using a counterfeit medicationcan lead to dangerous complications, said Dr. Daniela Hurtado Andrade, an endocrinologist at the Mayo Clinic in Jacksonville, Florida.
You never know what they are mixing them with, said Andrade, who spoke generally about the dangers of counterfeit drugs. There is the potential risk that they are mixed with electrolytes, which for example, can put a person at risk of having cardiac arrhythmias.
With counterfeit drugs, there s no way to know they re following health regulations.
If you are putting a contaminated substance under your skin, you can certainly be at risk of developing infections, she said. These are infections that are local, but then you could have certain complications of local infections that can become systemic infections.
Who is most at risk of counterfeit drugs?
Anyone who buys a GLP-1 drug without a prescription could be at risk of getting a counterfeit version.
The most vulnerable are people without adequate health care coverage or without prescription drug benefits, or who feel stigmatized by their weight and don t want to see a doctor, Timothy Mackey, a professor of global health at the University of California, San Diego, said.
The nature of the weight loss drugs large amounts of people qualify for them and their high cost make the problem even more challenging to control, said Mackay, who studies counterfeit drugs.
This situation is a bit different than prior counterfeit medicine incidents, as arguably so many people are at risk, he said. And consumers believe that they should be readily available, conveniently.
Safdar, of the Partnership for Safe Medicines, said the best way people can protect themselves is to always get the brand-name product through a prescription from a doctor.
He acknowledged that other people may not qualify for the drug s indicated use and will seek alternatives.
I ve seen people say, I got it because I was trying to lose that last 10 pounds, Safdar said. People are finding telehealth providers who will write that prescription and then dabbling in the market. None of that is safe.
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