Americans have long dreamed of a weight-loss drug that would help the pounds fall off. The good news is we now have those drugs. The bad news is the new drugs are in high demand, leading to short supplies. Plus, they can be expensive if insurance won’t cover them for weight loss. As a result, criminals are producing and selling counterfeit versions of the drugs that could have very serious side effects.
No one should be surprised. Counterfeit prescription drugs are a decades-old problem. The fakes are usually produced in developing countries and sold online, claiming to be the same U.S. Food and Drug Administration (FDA)-approved drugs that you can buy at a U.S. pharmacy, only at a much lower cost. They may even claim to be coming from Canada.
And it’s not just criminals making those assertions. A bipartisan group of politicians has made the same claims, even setting up state or municipal importation schemes to help patients buy prescription drugs, supposedly from Canada.
Virtually all of those schemes eventually failed, primarily for lack of use, though that hasn’t stopped new efforts. The importation failures are in part because the Affordable Care Act (ObamaCare), Medicare and Medicaid all have prescription drug coverage, so the allure of buying prescription drugs online from foreign sources has declined.
But that’s changing with the growing demand for the new injectable weight-loss drugs: Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy. (Note: Lilly’s Mounjaro and Novo Nordisk’s Ozempic are approved only for diabetes, but have been prescribed off-label for weight loss.)
The FDA has seen a significant increase in trafficking of counterfeit versions of these weight-loss drugs and has begun seizing suspected counterfeits as well as counterfeit needles used to inject them. In January, the FDA published letters warning two online vendors to stop selling “unapproved versions” of the weight-loss drugs.
Drug manufacturers are also getting involved. Last October, Lilly announced it was suing 11 foreign-based online pharmacies to stop them from selling and distributing products supposedly having the active ingredients in Mounjaro. Reuters reports, “Lilly said testing of AustroPeptide’s [an online pharmacy allegedly based in China] product purporting to contain the Mounjaro main ingredient tirzepatide showed it actually was ‘nothing more than sugar alcohol.’”
Lilly has also sued 10 U.S. medical spas, wellness centers and compounding pharmacies in several states that are selling products claiming to have the active ingredient.
In some cases, counterfeit drugs have little or none of the active ingredient. Indeed, they may contain chemicals that can harm the patient. In other cases, the drug may have been compromised by not keeping it refrigerated, putting it in an unsterile vile or bottle, or holding it long past its expiration date.
That’s why drug manufacturers and the FDA closely monitor a drug’s “chain of custody” to ensure it was made in an authorized facility and transported properly. When patients are harmed by fake drugs, they may blame, and maybe even sue, the manufacturer, even though the manufacturer had no role in making the counterfeit and warned against buying from unapproved sources.
And it’s not just a U.S. problem. “In October, the European Medicines Agency warned injection pens ‘falsely’ labeled as diabetes medicine Ozempic had been found in the European Union and the U.K.”
The World Health Organization (WHO) announced in January that “global shortages last year of popular diabetes medicines that are also used for weight loss, such as Novo Nordisk’s Ozempic, had been linked to rising reports of suspected counterfeits.”
A further complicating factor: While millions may want the drugs for weight loss — Goldman Sachs analysts are predicting 15 million adult users by 2030 — diabetics will need the drugs, yet they are also facing shortages because of the increased demand.
This fake-drug explosion could be a real threat to consumer safety. Patients need to take the FDA and WHO warnings seriously. I did a search for the drugs online and found websites claiming to have the drugs — even generic versions of the drug, which do not exist yet — for affordable prices. Some say you don’t need a prescription. They claim their “clinicians” are standing by to talk to you.
Be sure you talk to your doctor before you take a chance on something that may be a counterfeit drug. And listen to Dr. Sajani Shah, chief of the Weight and Wellness Center at Tufts Medical Center in Boston: “You don’t know where you’re getting these medications — if you get them at all — how they’re being processed, if they’re sterilized, and you can become very sick,” said Shah. “You have to be really careful because things, especially that you inject into yourself, you could have a very detrimental effect on your health.”