The weight loss drugs Wegovy and Zepbound are so popular that tens of millions of people around the world now take them and pharmaceutical companies have been unable to keep up with demand. This has led to the sale of knock-off medications, which many patients don’t realize aren’t the approved versions of the desired drugs.
When the U.S. Food and Drug Administration declares a drug is in short supply—as are Wegovy and Zepbound—copies of the medication can legally be made by what are known as compounding pharmacies. This niche industry typically alters medicines for individual patients, such as by removing an allergic additive or turning a pill into a liquid for someone with a swallowing disorder. Legitimate compounding pharmacies adhere to strict state and federal quality rules, says Al Carter, a pharmacist and executive director of the nonprofit National Association of Boards of Pharmacy.
But now sketchier compounders have flooded the market with bogus injections that at their best are less effective and at worst, are dangerous.
“The compound may contain something in it that is potentially injurious. They may not adhere to the same sterilization procedures. Or the product might not have the ingredients or the strength they say it does,” says Lydia Alexander, a physician in San Mateo, California, and president-elect of the Obesity Medicine Association.
Concerns about fraudulent ingredients
Along with lifestyle changes, weekly injections of the brand-name drug—which mimics the body’s own glucagon-like peptide-1 (GLP-1) hormone that send signals of fullness to the brain—help overweight people to successfully shed 10 percent or more of their bodyweight in a year.
Versions of the medications sold at medical spas or via apps, websites, or some telehealth providers are especially problematic, weight-loss physicians say. People turn to these sources because the shortage has made it difficult to find the brand-name drugs in their local pharmacies. Plus, medicines from these sources tend to be cheaper, which is appealing to people whose insurance doesn’t cover weight-loss drugs or whose insurance plans are adding hurdles that make getting approval increasingly difficult, Alexander says.
(New obesity drugs are coming. Here’s how they could change everything.)
Some of the counterfeit medicines use a salt form of semaglutide—the active ingredient in Wegovy—such as semaglutide sodium or semaglutide acetate. Despite the similar-sounding name, these are not FDA-approved medicines, which is why the agency has issued warning letters to several websites selling products containing these salts.
In one letter, the FDA noted that the labeling on the product actually states they are “research chemicals only” that are “not for human consumption.”
The FDA has also issued a warning to patients that these ingredients “have not been shown to be safe and effective” and have resulted in adverse events in people who have taken them.
“Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the warning states.
Earlier this year, the Obesity Medicine Association put out a statement that it does not recommend compounded obesity medicines and counsels patients, “if you use these compounded alternatives, you may not be getting what you hoped for.”
But proponents of compounding pharmacies say lumping legitimate compounders with sketchier companies only perplexes customers.
“We need to not confuse legitimate compounding with being able to order semaglutide online without a prescription or with companies using counterfeit semaglutide. That is not compounding and that is not pharmacy,” says Tenille Davis, the chief advocacy officer for the Alliance for Pharmacy Compounding, a trade association.
Scott Bruner, CEO of the Alliance for Pharmacy Compounding, says Novo Nordisk and Eli Lilly, manufacturers of Wegovy and Zepbound, are amplifying confusion by asserting that they do not sell their active ingredients to compounders, which implies that even legitimate compounders can’t safely buy them.
But Davis points to the more than 70 FDA-approved pharmaceutical wholesalers listed on the FDA’s website that legally sell bulk semaglutide and tirzepatide, the active ingredient in Zepbound.
Use caution when choosing a pharmacy
Some obesity physicians avoid recommending all compounding pharmacies to their patients because it is difficult for them to assess the quality of their manufacturing.
“There are horror stories of compounding facilities using toaster ovens for sterilization and pet beds near compounding areas,” says Nate Wood, an obesity medicine physician at Yale Medicine. In addition to safety issues, products made by questionable pharmacies might not yield results. Alexander points to patients who bought products online without her knowledge. “They tell me they’re hungry now, or they’ve gained back weight.”
Medical spas, which may sell products made by compounding pharmacies, might not properly screen patients for suitability, says Andrew Kraftson, an endocrinologist and director of the weight navigation program at the University of Michigan.
“If I prescribe Wegovy, I don’t get any money,” Kraftson says, contrasting this with medical spas that both prescribe the medicine and sell it. He’s also concerned these outlets might not include important lifestyle advice or follow people’s progress long-term, both of which are required for weight-loss success.
(Losing weight leads to better health? Not necessarily)
Carter recommends that people use compounding pharmacies only if they or their physicians are comfortable with the pharmacy, by speaking directly to the pharmacist to understand the ingredients they’re using and their experience manufacturing sterile drugs. People can also look online on their state’s board of pharmacies website to ensure they don’t have a disciplinary history, Davis suggests.
When it comes to weight loss, GLP-1 drugs can be an important tool for some patients, Wood says. “They’re getting at the root cause of obesity, which is why they’re so effective.”
But buying from a questionable source, even if the product is hard to get legitimately, is a mistake, Kraftson says. “The risk is not worth it.”
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