Ozempic, Semaglutide Users Ignore FDA Warning on Compound Drugs

By CT Jones

Before August 2021, Emily Clasen had never heard of Ozempic. The 31-year-old from Fort Wayne, Indiana tells Rolling Stone that after her best friend at work mentioned the drug, she brought it up with her doctor. She had tried other weight loss drugs, like phentermine, but the side effects made her heart race. She needed a solution.

"At that time I was weighing 350 pounds," Clasen says. "And I was very ashamed but diet and exercise was not doing it for me."

After speaking with her doctor, Clasen was prescribed Mounjaro, a name-brand version of tirzepatide, in a similar class as Ozempic. A year-long savings card from pharmaceutical company Eli Lilly took the out-of-pocket cost down from $1,600 a month to $25. And in her first year on the medication, she lost 87 pounds. But more than weight loss, Clasen says she was able to change how she viewed her eating habits — and herself.

"Doing this has allowed me to be free," Clasen says. "A lot of people who are on this journey deal with body dysmorphia, and it is extremely toxic. It's terrible to look at yourself in the mirror and hate everything. You want to cut away everything that you see. Losing this weight isn't just so I can be thin and pretty. It's so I can love myself. So I can want to get up every day."

While Ozempic is often shorthand for all semaglutide drugs, there's a wide range of options on the market. Ozempic and Mounjaro, which are injected, as well as the oral tablet Rybelsus, are only approved for treating type 2 diabetes in adults, while Wegovy is approved by the FDA for weight loss. As demand for semaglutide drugs has doubled since 2021, the FDA is now warning that compounded versions — mixed and tailored by a pharmacist but not manufactured by a name-brand company — could cause adverse and dangerous side effects. But the high price of name-brand options could lead patients to ignore the warning — and Clasen might be one of them.

"A lot of people are saying ‘My insurance is not going to help me. What do I do?’" Clasen says. "Me and many other people, excuse my language, are shit out of luck."

Semaglutide drugs have been called many things: a cure-all, a money grab, a cop-out, a miracle drug. But their actual effect on the body is pretty straightforward: "Semaglutide mimics the function of a hormone called GLP-1," explains Dr. Priya Jaisinghani, an endocrinologist and obesity medicine specialist at NYU Langone. "GLP-1 is a hormone made in the intestine that regulates your blood sugars by acting on insulin and glucagon levels. It slows down the emptying of the stomach and it leads to decreased appetite." Its original purpose was for people with type 2 diabetes, but its success in decreasing appetite and hunger levels has also made it a desirable option for people desperate to lose weight.

While Ozempic has become the face of semaglutide's growing demand, a lack of education means the potential dangers of compounded semaglutide have become confusing for the average consumer, according to Jaisinghani. "Compounding is the process of combining, mixing, or altering two or more stronger ingredients to create a custom-tailored medication," Jaisinghani says. While compound pharmacies are common, each state has different standards, and with the rise of telehealth programs, it's easier than ever for patients to use online healthcare options to purchase compounded versions of medication. But Dr. Lemrey "Al" Carter, executive director of the National Association of Boards of Pharmacy, tells Rolling Stone that high-demand products like semaglutide can be targets for internet pharmacies who know people will pay — and not ask questions.

"All [legitimate] compounding pharmacies are regulated by the state boards of pharmacy," Carter says. "Online pharmacies can often operate illegally. They’re either not licensed in a state they’re shipping to, or they are not requiring prescriptions for dispensing prescription drug products, or they’re not following specific laws, rules, and regulations that pertain to the practice of compounding pharmacy."

According to the FDA, they’ve received reports that patients taking the compounded version of Ozempic have had "adverse effects." They also noted people could be using doses of semaglutide that are derived from a salt — which haven't been tested — rather than its pure form. A spokesperson for the FDA tells Rolling Stone that the agency did "not have any specific information to provide" regarding adverse events," but directed people to the alert for additional information on the potential harm of compounds.

Jaisinghani adds that the salt form of semaglutide has different active ingredients than the name-brand version. Not only is it not FDA approved, but if a compound pharmacy is claiming to make their version from approved ingredients, it's unclear where they are sourcing from, as parent company Novo Nordisk does not sell the active ingredient for compounding purposes.

"We are aware that several compounding pharmacies, weight loss clinics, and medical spas are claiming to sell or offer compounded products purporting to contain ‘semaglutide,’" Novo Nordisk said in a statement to Rolling Stone. "Novo Nordisk is actively monitoring and taking action (including but not limited to issuing cease-and-desist letters) against these entities that are engaging in the unlawful sale of compounded semaglutide, disseminating false advertising, and infringing its trademarks. No FDA-approved generic versions of semaglutide currently exist."

And potential harm could be more than just diarrhea or headaches. Both the FDA and Jaisinghani pointed to a 2012 fungal meningitis outbreak that began in a compound pharmacy when a Massachusetts compounder shipped drugs contaminated by a fungus. The medicine was injected directly into people's joints and spines, giving them fungal infections that led to meningitis. According to the FDA, over 14,000 patients were exposed to the contaminated shipment, 750 people in 20 states got sick, and more than 60 people died. The FDA considers the fungal meningitis outbreak one of the "most serious [outbreaks] associated with contaminated compounded drugs in recent history." Because the FDA does not test and regulate products from compound pharmacies, the agency only knows of adverse events when people submit reports or a "state official notifies the FDA." But even with the risks, there's a large reason why so many consumers are turning to compounded versions of semaglutide: the cost.

When May West was in college, around 2005, she was diagnosed with polycystic ovary syndrome, also known as PCOS, a hormonal imbalance that can cause increased weight gain. A 14-year prescription for metformin, another diabetic medication with weight loss benefits, helped her keep weight off. But after stopping while she was pregnant, West tells Rolling Stone her postpartum weight got out of control. With help from her OBGYN, she found a helpful balance in Wegovy and began to lose weight — until the drug's popularity and a change in her insurance policy took her from paying $25 a month to a potential cost of $900.

"Wegovy has totally changed my life," West says. "I have so much energy now. My insulin is back to normal. The medicine was working for me and I didn't want to get off of it. This was my only option."

After speaking with her doctor, West went to a weight loss clinic that had partnered with a compound pharmacy. Now, she spends only $100 a month for a maintenance-level dosage. While she's fully aware of the FDA's warnings against compounded semaglutide, she tells Rolling Stone that she feels so much better on the medication that it would take an intense side effect to get her to stop taking it.

"Side effects aren't fun. But I don't feel different," West says. "I read the FDA statement, but it was very blank. Tell me why I shouldn't use it. Tell me someone got cancer and died from taking this. Otherwise, what are my other options?"

As for Clason, come June 30, her Eli Lilly savings card will end — forcing her to choose between paying out of pocket and finding the drug somewhere else. She hasn't decided whether she’ll stop taking her medication or choose a compound version. She adds that the FDA warning has driven her to be rigorous in her search for a legitimate compound pharmacy, but she knows that there are people so desperate for the drug that they will ignore red flags and choose worse options.

"I am still in limbo. I want to find a good pharmacy that is regulated and surveyed," Clasen says. "The people who this has worked for [who] don't have $400 or $500 to spend a month, I think they’re gonna look past legitimacy and they’re gonna go for the price. The compound pharmacies are a scary option, but I’m thankful and grateful we have them."

West and Clasen aren't the only ones making a decision the FDA has called dangerous. Across social media, news of the FDA warning hasn't slowed down searches for compounded semaglutide. On TikTok, hashtags related to semaglutide have been viewed over 100 million times, and under #compoundsemaglutide, videos sharing how to get cheaper and compounded versions online overwhelm providers encouraging people to listen to the FDA warning.

Ashley Dunham, creator of Bossfidence consulting, is a popular semaglutide influencer on TikTok. She's also one of the owners of a wellness clinic, which is where she got access to compound semaglutide for the first time, and has been taking it for over 10 months. In addition to losing 85 pounds, Dunham, who also suffers from PCOS, says her symptoms changed so much for the better that she wrote a book called The Girl's Guide to Losing Weight on GLP-1 Medication. She is also active on TikTok, where she gives her followers tips on the best ways to take semaglutide and keep their weight off. Dunham tells Rolling Stone that while she agrees that people should look for reputable compounding pharmacies, she blames pharmaceutical companies for not addressing the shortage fast enough, and not working with insurances to make sure as many patients are covered as possible.

"People are desperate for this medication. I honestly wish that the manufacturers would take a little bit more accountability," Dunham says. "They’re running commercials on TV, they are advertising at baseball games. They’re really pushing the message of their medication but they cannot meet the demand."

Dunham has never taken a name-brand version of semaglutide — and she doesn't plan on it. While she's had plenty of side effects (nausea, migraines, constipation) she says additions in her compound of B12 make her side effects much more mild.

Its effective and my blood work has never looked better babes ✨ #CapCut #semaglutide #ozempic #wegovy #mounjaro #compoundedsemaglutide #compoundedtirzepatide #compoundedmounjaro #compoundedozempic #weightlossmotivation

But while Dunham might feel better, Jaisinghani tells Rolling Stone that the addition of anything not found in the name-brand versions immediately calls into question both safety and efficacy. She also adds that compounded versions, which are packaged in vials rather than pre-filled injectables, can have unclear dosing, storage requirements, and shelf life.

"There are no studies to support these purported claims in humans or even studies on safety and efficacy with these specific combinations of ingredients," Jaisinghani says. "They do not have the same safety, quality, effectiveness, rules, regulations, and assurances as FDA-approved drugs. They’re not the same thing."

And while doctors like Jaisinghani and the FDA have continued to warn people about the dangers of compounded semaglutide, it's clear that the medical community is facing an uphill battle: getting people to choose between feeling better or being safe. "If you’re unable to access a drug due to cost, or due to shortages, you should always seek your doctor as early as possible to create a plan that best suits you," Jaisinghani tells Rolling Stone. "Compounded semaglutide may be considered as a low-cost alternative. But what it may cost is your health." The problem is that most people taking compound semaglutide know the warning now. The bigger fight might be getting them to listen.

"I went from a body I knew very well to a body I didn't recognize at all. Being placed in a plus size box, it's hard on your mental health and your physical health," Dunham says. "I would take 10 times the side effects over how I felt every single day being overweight."

June 8, 2023, 5:45 p.m.: Correction: An earlier version of this article stated that Mounjaro is a semaglutide. It is a tirzepatide, which is a similar drug used to treat diabetes that also helps with weight loss.