Is that secure and efficient for weight reduction?

When Robin Langois, 58, was prescribed the weight-loss drug Wegovy final yr, she couldn’t afford the excessive price ticket after her insurance coverage wouldn’t cowl it.

However she later found on TikTok that folks may get their palms on what seemed to be the drug’s energetic ingredient, semaglutide, from compounding pharmacies for a fraction of the value.

Langois, of Tucson, Arizona, stated she was initially hesitant, due to security issues, however she finally discovered a telehealth supplier to write down her a prescription.

“I’m not 100% certain it’s what I’m getting,” Langois stated. She famous, nevertheless, that she’s skilled emotions of fullness and weight reduction, in addition to nausea, a typical facet impact of the drug. “It’s working prefer it ought to,” she stated.

Both attributable to value or ongoing shortages, individuals are searching for alternate options to the model identify medicines Ozempic and Wegovy, each of which comprise the energetic ingredient semaglutide.

Some folks, like Langois, are turning to compounding pharmacies for the difficult-to-get weight reduction medication.

Novo Nordisk, the only real producer of Ozempic and Wegovy and the patent-holder of semaglutide, stated in an announcement that it doesn’t present the ingredient to those pharmacies, main some consultants to query the place pharmacies are sourcing the drug — and whether or not it’s semaglutide in any respect.

“That’s the million-dollar query,” stated Dr. Fatima Cody, a doctor specializing in weight problems at Massachusetts Basic Hospital in Boston who serves as an adviser to Novo Nordisk.

What are compounding pharmacies?

Compounding pharmacies combine and alter drug components to create medicines tailor-made to particular affected person wants, in response to the Meals and Drug Administration. 

Compounded medicines are normally created utilizing the energetic components in medication. In Ozempic’s and Wegovy’s case, that is semaglutide. 

However compounded medication — whereas they comprise FDA-approved components — will not be themselves authorized by the FDA, which means they don’t seem to be regulated, monitored or examined by the company, stated Benjamin Jolley, a pharmacist and proprietor of Jolley’s Compounding Pharmacy in Salt Lake Metropolis. 

Hospitals will generally use a compounded medicine when a commercially out there choice isn’t perfect, in response to the FDA. They might decrease the dosage of ache medicine to forestall some uncomfortable side effects, for instance, or take away preservatives or dyes that will trigger an allergic response. 

The FDA may also grant exemptions that permit compounding pharmacists to make sure medicines if there’s a scarcity, stated Jeremy Kahn, a spokesperson for the company.

Are compounding pharmacies providing actual semaglutide? Is it secure?

Dr. Chris McGowan, who runs a weight reduction clinic in Cary, North Carolina, has seen that compounded variations of Wegovy and Ozempic are rising in recognition.

“What I’m listening to from sufferers is, ‘Oh, hey, I heard about this compounded semaglutide. Can I attempt that?’” he stated. 

Mary Morgan Mills, 32, of Raleigh, North Carolina, got here to McGowan after taking what she was instructed was a compounded model of semaglutide for a couple of yr. 

The weekly injection, which she acquired at a wellness middle, made her nauseous, and he or she solely misplaced about 15 kilos whereas taking it.

“I felt bamboozled,” she stated, including that she nonetheless had “bottles of it in my fridge.”

“I’ve at all times needed to go get it examined to see what it really is, however I do not know the method,” Mills stated.

McGowan stated that compounding pharmacies, in lots of situations, will not be being totally clear about how they’re sourcing the drug.

Jolley, who doesn’t provide semaglutide, stated it’s potential compounding pharmacists might be giving folks semaglutide sodium, a less expensive and modified model of the compound that’s supposed for analysis use solely. Semaglutide sodium, nevertheless, isn’t authorized by the FDA, he stated, which might make promoting the product unlawful.

Compounding pharmacists is also buying excessive doses of semaglutide from wholesalers after which separating it into smaller dosages or mixing it with different drug components, he stated. 

Matt Buderer, a pharmacist and proprietor of the Buderer Drug Firm Compounding Pharmacy in Ohio, stated that will basically dilute the medicine, which he stated doesn’t make sense as a result of that will make the drug much less efficient.

If what compounding pharmacies are providing as semaglutide isn’t really the drug, it’s in the end a security concern, as a result of the components they’re utilizing might not be totally evaluated by the FDA, McGowan stated.

“What I’m telling sufferers is to be very cautious when contemplating any type of compounded semaglutide or compounded tirzepatide, which is one other medicine we’re seeing presently being provided in a compounded kind,” he stated. (Tirzepatide is a diabetes drug made by Eli Lilly that additionally has weight reduction results.)

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