All the Rage: Combatting Counterfeit Weight-Loss and Diabetes Drugs

As online ads abound for diabetes and obesity medications, endocrinologists should be prepared to talk to patients who may be attracted to GLP-1 drug lookalikes and supplements from questionable sources.

GLP-1 agonists are a cultural phenomenon. Celebrities and social media influencers hyping the drugs’ weight-loss success has led to demand outstripping supply, resulting in shortages for some patients who could benefit the most. High costs and limited insurance coverage have led patients to look for more affordable alternative sources.

This success and notoriety have opened an attractive opportunity for imitators and quick-buck artists. With many consumers turning to online sources, the U.S. Food and Drug Administration has warned potential customers about the dangers of these products and written warning letters to many companies with websites that market these drugs and supplements.

Illegal Online Pharmacies

The authors of a recent research letter in JAMA (“Safety and Risk Assessment of No-Prescription Online Semaglutide Products” by Ashraf AR, Mackey TK, Schmidt J, et al.) did online searches for semaglutide and found that about 42% of the results “belonged to illegal pharmacy operations.” When the researchers ordered products from six of these vendors, three of them failed to deliver a product, and instead engaged in scams requesting additional payments. Analysis of the products that did arrive revealed problems with potential contamination, purity, and semaglutide content. The authors note that “U.S. poison control centers have reported a 1,500% increase in calls related to semaglutide.”  

“It’s essential to have an open conversation about the risks of using unregulated medications. I recently saw a patient for the first time regarding thyroid concerns. Towards the end of the visit, she mentioned that she had been using Wegovy, which she purchased from an online pharmacy, for the past few months, paying a significant amount out of pocket. She hasn’t experienced much success with weight loss and wanted to know if the severity of her nausea and vomiting was normal. She’s been spending a lot of money without any weight loss results but is dealing with all the side effects.” — Osama Hamdy, MD, PhD, medical director, Obesity Clinical Program, Joslin Diabetes Center; associate professor of medicine, Harvard Medical School, Boston, Ma.

“The main message here is that alternative sources of drugs, particularly counterfeit options, are not regulated and we do not have certainty of the quality of the product or whether this is the true medication,” says Rodolfo J. Galindo, MD, associate professor of medicine at the University of Miami Miller School of Medicine.

“The study emphasizes the urgent need for increased awareness and regulation to address the sale of these dangerous counterfeit drugs,” agrees Priyanka Majety, MD, assistant professor in the Division of Endocrinology, Diabetes and Metabolism at Virginia Commonwealth University. “The National Association of Boards of Pharmacy, representing state pharmacy regulators, has identified over 40,000 online pharmacies operating illegally or in ways that are not recommended.”

Counterfeiters

The potentially lucrative market has attracted largescale counterfeiting networks with ties to organized crime. The World Health Organization has reported finding counterfeit Ozempic in several countries, including the U.S.

The U.S. Food and Drug Administration has said it has seized thousands of units of counterfeit Ozempic — including in the legitimate drug supply. Some of these counterfeit products have been found to contain insulin, with obvious serious health risks.

Physicians should be on the lookout for these, says Osama Hamdy, MD, PhD, medical director of the Obesity Clinical Program at Joslin Diabetes Center and associate professor of medicine at Harvard Medical School: “There are ways to identify counterfeit medications. These can include small irregularities, such as spelling mistakes on the packaging or flimsy labels that don’t adhere properly to the pen. Both the FDA and Novo Nordisk have provided helpful information, including photos, to help differentiate genuine from counterfeit products.”

Eli Lilly has also expressed concern about the proliferation of counterfeit versions of its tirzepatide medications and said it is “filing several legal actions against med-spas, wellness centers, and other entities selling unapproved compounded products containing what they claim is tirzepatide.”

Online Marketing

Consumers can be exposed to pitches from these suppliers without even looking for them. On the local website Nextdoor, posts asking for help in finding lost pets or recommendations for appliance repairs are interspersed with advertisements from companies like FuturHealth, which feature slim young women in form-fitting clothes brandishing injection pens that appear to be Ozempic. A click on the ad takes the viewer to a short questionnaire where one can qualify for the company’s weight loss programs, with promises of prescriptions. If you click on the Nextdoor ad, you can look forward to future ads popping up on your news feed from the same company with a picture of what looks like an Ozempic package emblazoned with the claim: “Ozempic prescription – 5 mins – no insurance needed.”

Social media influencers and people famous for being famous have also climbed on the GLP-1 bandwagon. For example, Kourtney Kardashian has a website that markets “Lemme GLP-1 Daily Capsules,” which are a “GLP-1 Support, Appetite & Weight Management Supplement… formulated with clinically-tested ingredients.”

Talking with Patients

Majety recommends being proactive in talking to patients about these drugs: “Asking in a non-judgmental manner if patients are using any supplements or medications for weight loss not only builds trust but also allows us to better assist them. If we don’t ask, we may never know. Patients can sometimes be hesitant to share this information with their doctors, fearing it may affect trust.”

“It’s essential to have an open conversation about the risks of using unregulated medications,” Hamdy agrees. “I recently saw a patient for the first time regarding thyroid concerns. Towards the end of the visit, she mentioned that she had been using Wegovy, which she purchased from an online pharmacy, for the past few months, paying a significant amount out of pocket. She hasn’t experienced much success with weight loss and wanted to know if the severity of her nausea and vomiting was normal. She’s been spending a lot of money without any weight loss results but is dealing with all the side effects.”

Compounding the Problem

An additional complicating wrinkle is that the FDA put semaglutide and tirzepatide  on its shortage list in 2022, which enabled compounding pharmacies to legally market their own versions. Even so, the FDA notes that “compounded drugs are not FDA-approved or evaluated for safety and effectiveness,” and that the manufacturers do not face the same level of scrutiny as regular pharmaceutical manufacturers.

“This is a challenging situation. We encounter patients every day who would greatly benefit from these medications, but their insurance won’t cover them. So, while it’s unfortunate that some patients are turning to unregulated online pharmacies to get these medications, it’s not entirely surprising.” — Priyanka Majety, MD, assistant professor, Division of Endocrinology, Diabetes, and Metabolism, Virginia Commonwealth University, Richmond, Va.

Further, although marketers often say that their product contains the “same active ingredient” as semaglutide, an FDA notice says: “Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products. In some cases, the compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used in the approved drugs, which contain the base form of semaglutide,” and have not been evaluated for effectiveness.

“FDA has received adverse events reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available,” the FDA says.

In early October, the FDA took tirzepatide off the shortage list, meaning compounding pharmacies could no longer dispense it. But the FDA kept semaglutide on the shortage list.

Galindo says that “recommending non-FDA regulated drugs may not be safe for patients,” so he advises his patients on the lack of regulatory and scientific information on quality, quantity, or safety of alterative sources of drugs.

“This is a challenging situation,” says Majety. “We encounter patients every day who would greatly benefit from these medications, but their insurance won’t cover them. So, while it’s unfortunate that some patients are turning to unregulated online pharmacies to get these medications, it’s not entirely surprising.”

“The 1,500% increase in calls to U.S. poison centers related to semaglutide highlights the growing need for stronger pharmacovigilance, particularly regarding the risks of purchasing drugs online,” she concludes.

Seaborg is a freelance writer in Charlottesville, Va. In the October issue, he wrote about the increased awareness surrounding polycystic ovary syndrome (PCOS).

Editor’s Note: As of this issue’s publication date, the FDA is reevaluating its decision to remove tirzepatide from its drug shortage list.