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Readers had many questions about my column this week urging caution on purchasing knock-off versions of popular weight-loss drugs. Here are some answers.
First, a clarification on what drugs we are talking about. Aaron from New York asks, “I thought Ozempic was only used for diabetes, not weight loss, so isn’t everyone on it using it for lifestyle and not medical reasons? Also, do your warnings apply for what my friend is taking, Mounjaro?”
There are two main drugs here, both part of a class a drugs known as GLP-1 agonists. The first is semaglutide, which is manufactured by Novo Nordisk and approved by the Food and Drug Administration to treat diabetes and obesity under brand names Ozempic and Wegovy, respectively. If a patient is being prescribed semaglutide to treat diabetes, they should get Ozempic. If it’s to treat obesity, the medication should be Wegovy.
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Physicians are also able to prescribe these medications “off-label,” meaning they can prescribe Ozempic to patients without diabetes for weight-loss purposes. Anecdotally, this practice has been very common because Wegovy is extremely difficult to access.
Follow this authorLeana S. Wen's opinionsThe second drug, tirzepatide, is manufactured by Eli Lilly and approved for diabetes treatment under the brand name Mounjaro. A recent clinical trial found that tirzepatide is highly effective in achieving weight loss, too. After about 2½ months on the drug, patients lost up to 34 pounds. This is comparable and possibly even superior to weight loss achieved from semaglutide. It is likely that tirzepatide will be also approved to treat obesity; in the meantime, it is also being prescribed off-label to patients seeking weight loss.
Emily from Michigan is among the readers obtaining such drugs from online pharmacies. “I get [tirzepatide] for a quarter of the cost than I would at Walgreens,” she wrote. “I looked on the website you recommended, and the place I get my Mounjaro from isn’t on the list of fake stores. That means it’s pretty safe, right?”
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Not necessarily. I spoke with Lemrey Carter, executive director of the National Association of Boards of Pharmacy. His organization has a team that investigates rogue internet retailers. Every week, they find “an average of around 200 pharmacies” that are acting illegally. These entities are not licensed to distribute medications in the United States, and there is no mechanism to know what they are really selling.
Patients could be receiving a saline vial that doesn’t have any medication in it, Carter told me. “Or it may have too much of the drug. Or it may be laced with another product.”
This is terrifying. I will never forget speaking with a mother whose son, a college freshman, died after he took pills purchased from the internet that were laced with fentanyl. Buying medicines from rogue websites is like playing Russian roulette; in addition to potentially losing your money, you could end up taking a deadly dose of a drug that’s not at all what you ordered.
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Carter’s organization places these illegal websites on the public alert list that Emily referenced. But this is like playing whack-a-mole. “What they’ll do is take down that site and put another site in place of it,” he said. “You take down 15 and they’re going to put 20 more up.”
He offers the following tell-tale signs that consumers should look for. First, prescription medications require the involvement of a health-care provider, so avoid any website that will sell drugs without a prescription.
Second, legitimate online pharmacies must provide a physical U.S. address and telephone number and offer the opportunity to speak with a licensed pharmacist. Pharmacies are licensed through state boards of pharmacy, and you can use this FDA resource to make sure the pharmacy is listed.
Third, semaglutide and tirzepatide are very expensive. Without insurance coverage, they cost about $1,000 for a one-month supply. Online sellers that offer them at deep discounts are probably fraudulent.
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Carter is also concerned about “medical spas” that are making compounded GLP-1s. These are physical clinics, often located in shopping complexes and strip malls, that have added weight-loss drugs to the other questionable “medical” services they offer, such as intravenous vitamin infusions and cosmetic procedures. Unlike compounding pharmacies that are licensed by states or mass compounding facilities directly overseen by the FDA, these spas might lack sterile equipment and pharmacist expertise to appropriately reconstitute medications.
Patients obtaining their weight-loss drugs from medical spas or wellness centers should ask whether the medication they are receiving is compounded, and if so, where it was done. Verify that the entity is a licensed compounder and make sure the active ingredient and dosages are correct.
The bottom line: I urge patients to use the drugs made by the manufacturer, which are FDA-approved, rather than the non-FDA-approved knock-off versions. Those who are unable to obtain the manufacturer versions because of the current shortage or cost should think through the risks and benefits of alternate routes. At the very least, they should stay away from rogue websites and medical spas that are not licensed to compound drugs.
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Semaglutide, tirzepatide and similar drugs offer incredible hope to treat chronic conditions of diabetes and obesity. I have friends, colleagues and patients who will attest that these medications have dramatically improved their health and changed their lives.
But these are not drugs for people following celebrity trends to shed a few pounds for cosmetic purposes. Such use of the medications, if purchased from manufacturers, will worsen the shortage for others. If purchased through other means, it could pose real health threats.
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