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Compounded Ozempic and Wegovy: Is that safe and effective for weight loss?

When Robin Langois, 58, was prescribed the weight-loss drug Wegovy last year, she couldn’t afford the high price tag after her insurance wouldn’t cover it.

But she later discovered on TikTok that people could get their hands on what appeared to be the drug’s active ingredient, semaglutide, from compounding pharmacies for a fraction of the price.

Langois, of Tucson, Arizona, said she was initially hesitant, because of safety concerns, but she eventually found a telehealth provider to write her a prescription.

“I’m not 100% sure it’s what I’m getting,” Langois said. She noted, however, that she’s experienced feelings of fullness and weight loss, as well as nausea, a common side effect of the drug. “It’s working like it should,” she said.

Either due to cost or ongoing shortages, people are seeking alternatives to the brand name medications Ozempic and Wegovy, both of which contain the active ingredient semaglutide.

Some people, like Langois, are turning to compounding pharmacies for the difficult-to-get weight loss drugs.

Novo Nordisk, the sole manufacturer of Ozempic and Wegovy and the patent-holder of semaglutide, said in a statement that it does not provide the ingredient to these pharmacies, leading some experts to question where pharmacies are sourcing the drug — and whether it is semaglutide at all.

“That’s the million-dollar question,” said Dr. Fatima Cody, a physician specializing in obesity at Massachusetts General Hospital in Boston who serves as an adviser to Novo Nordisk.

What are compounding pharmacies?

Compounding pharmacies mix and alter drug ingredients to create medications tailored to specific patient needs, according to the Food and Drug Administration. 

Compounded medications are usually created using the active ingredients in drugs. In Ozempic’s and Wegovy’s case, that's semaglutide. 

But compounded drugs — while they contain FDA-approved ingredients — are not themselves approved by the FDA, meaning they are not regulated, monitored or tested by the agency, said Benjamin Jolley, a pharmacist and owner of Jolley’s Compounding Pharmacy in Salt Lake City. 

Hospitals will sometimes use a compounded medication when a commercially available option is not ideal, according to the FDA. They may lower the dosage of pain medication to prevent some side effects, for example, or remove preservatives or dyes that may cause an allergic reaction. 

The FDA will also grant exemptions that allow compounding pharmacists to make certain medications if there is a shortage, said Jeremy Kahn, a spokesperson for the agency.

Are compounding pharmacies offering real semaglutide? Is it safe?

Dr. Chris McGowan, who runs a weight loss clinic in Cary, North Carolina, has noticed that compounded versions of Wegovy and Ozempic are growing in popularity.

“What I’m hearing from patients is, ‘Oh, hey, I heard about this compounded semaglutide. Can I try that?’” he said. 

Mary Morgan Mills, 32, of Raleigh, North Carolina, came to McGowan after taking what she was told was a compounded version of semaglutide for about a year. 

The weekly injection, which she received at a wellness center, made her nauseous, and she only lost about 15 pounds while taking it.

“I felt bamboozled,” she said, adding that she still had "bottles of it in my fridge."

"I've always wanted to go get it tested to see what it actually is, but I don't know the process," Mills said.

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McGowan said that compounding pharmacies, in many instances, are not being fully transparent about how they’re sourcing the drug.

Jolley, who does not offer semaglutide, said it’s possible compounding pharmacists could be giving people semaglutide sodium, a cheaper and modified version of the compound that’s intended for research use only. Semaglutide sodium, however, isn’t approved by the FDA, he said, which would make selling the product illegal.

Compounding pharmacists could also be purchasing high doses of semaglutide from wholesalers and then separating it into smaller dosages or mixing it with other drug ingredients, he said. 

Matt Buderer, a pharmacist and owner of the Buderer Drug Company Compounding Pharmacy in Ohio, said that would essentially dilute the medication, which he said doesn’t make sense because that would make the drug less effective.

If what compounding pharmacies are offering as semaglutide is not actually the drug, it’s ultimately a safety issue, because the ingredients they are using may not be thoroughly evaluated by the FDA, McGowan said.

“What I’m telling patients is to be very careful when considering any form of compounded semaglutide or compounded tirzepatide, which is another medication we’re seeing currently being offered in a compounded form,” he said. (Tirzepatide is a diabetes drug made by Eli Lilly that also has weight loss effects.)

Source: https://www.nbcnews.com/health/health-news/ozempic-wegovy-semaglutide-compounding-weight-loss-safe-rcna72990


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