Compounded GLP-1s

The surge in demand for semaglutide has created a complex market with significant safety challenges - Robyn Spurr

Compounded GLP-1s
Compounded GLP-1s

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The Truth About Compounded GLP-1 Drugs

GLP-1 medications are everywhere these days — especially online. A quick scroll through social media can bring up a wide range of companies and influencers touting the benefits of GLP-1 drugs, and women tend to be the target audience. A recent study in the Journal of Medical Internet Research found most of the posts about GLP-1s highlighted positive benefits for women’s health. And while it’s true that GLP-1 drugs have proven benefits for some people, not all GLP-1 medications are the same. And not everything you’re reading online is true.

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Featured

 Out of Shortage, Into Controversy: The Fight Over GLP-1 Compounding

We are witnessing the most significant events in compounding history play out as some of the challenges to GLP-1 compounding are addressed in court. The discussion under way gets to the very essence of compounding itself.

 The Dangerous Allure of Compounded GLP-1 Drugs

While compounded medications help fill a necessary gap, they can have significant safety issues. Because of less stringent regulatory oversight, patient safety may be compromised by contamination, inaccurate potency, or inconsistent quality. A compounded GLP-1 product may not even contain the same active ingredient found in the branded versions.

Articles of Interest

Is Compounded Semaglutide Safe to Use?

Compounded medications can offer a cheaper way to obtain scarce drugs. But the FDA has raised concerns about salt-compounded forms of semaglutide, which may not be safe or effective.

Semaglutide: beware of buying the weight-loss drug online

Even if it is legal to produce compounded versions of semaglutide, these versions are still prescription drugs. This means that online buyers without prescriptions face two somewhat alarming possibilities: either they’re not getting semaglutide legally, or they’re not getting semaglutide at all.

What You Need to Know About Compounded Versions of Popular Weight Loss Drugs

But as with many situations in which supply far exceeds demand, questionable versions of these drugs are making their way into desperate patients’ hands, and doctors are concerned about what exactly these versions contain. Some online sellers are exploiting the opportunity to cash in, selling knockoffs of Wegovy, whose active ingredient is semaglutide, that may not even contain semaglutide.

Buyer beware: Off-brand Ozempic, Zepbound and other weight loss products carry undisclosed risks for consumers

For people who cannot afford a compounding pharmacy product, or cannot get a valid prescription for semaglutide or tirzepatide, opportunistic companies are stepping in to fill the void. These include “peptide companies,” manufacturers that create non-FDA approved knockoff versions of the drugs.

Compound weight-loss drugs are everywhere. The FDA is cracking down

The recent withdrawal of Hims & Hers’ GLP-1 pill raises questions about the safety and effectiveness of compounded medications

Compounded (And Counterfeit) Semaglutide

So it's a confusing landscape out there. My guess is that a significant amount of the stuff coming from the compounding pharmacies is not quite Ozempic, since there's not enough of that to go around at the moment, and in some cases it may be even worse than that. There is truly no way for the patients involved to know what they're getting in such cases, which is where the libertarian "let 'em try it" position starts to break down.

Compounded GLP-1s Are Going Away. Here’s What To Do If You Take Them

Compounding pharmacies have been allowed to make generic versions of Ozempic, Mounjaro, and similar drugs — until now.

Compounded semaglutide is an ill-defined public health crisis

As a cardiologist, I’m seeing vulnerable patients seeking Wegovy and other GLP-1s turn to questionable yet convenient solutions online.

Compounded Semaglutide: Is it worth the risk?

This drug was first approved in 2017 by the brand name Ozempic® for the treatment of diabetes. Due to its effects on weight loss, semaglutide was also approved in 2021 for weight management under the name Wegovy®. The sheer popularity of this drug has resulted in supply shortages, prompting some people to seek out compounded versions of the drug instead.

Compounded Weight Loss Medications: What are They and What are Their Risks?

The FDA defines “traditional” pharmacy compounding as “combining, mixing, or altering ingredients to create a customized medication for an individual patient based on a licensed practitioner’s prescription.” Compounded drugs use FDA-approved ingredients, but the customized medication itself is not FDA-approved. This means the FDA does not specifically review the safety, effectiveness, or quality of compounded medications before they are given to patients.

FDA Warns People Not to Use Off-Brand Versions of Ozempic and Wegovy

Agency officials said this week that they have received reports of problems after patients used versions of semaglutide, the active ingredient in the brand-name medications, which have been compounded, or mixed in pharmacies. Officials didn’t say what the problems were.

Health Access to Compounded GLP-1s Is Drying Up. Here’s What to Know About the Copycat Weight-Loss Drugs

Recent FDA changes have thrown their availability into legal limbo.

Is Semaglutide Safe? What You Need to Know

As with most drugs, the potential benefits of semaglutide come with certain risks.

More People Are Overdosing on Ozempic Alternatives

Some patients say it’s easy to get the do-it-yourself doses of compounded semaglutide wrong.

Obesity specialists warn against 'bootleg' weight-loss drug

Semaglutide, a weight-loss drug developed by Novo Nordisk, is currently in short supply due to high demand, leading some people to seek out "generic" or compounded versions of the drug instead... But obesity specialists warn against using compounded semaglutide since its quality and safety cannot be guaranteed.

What Are the Safety Concerns Regarding Compounded GLP-1 Receptor Agonists?

Despite FDA warnings against using non-approved compounded versions when FDA-approved medications are available, the market for these knockoff products has surged, with many active pharmaceutical ingredients (APIs) arriving from unregistered, foreign manufacturers.7 Poorly regulated compounding practices and unvetted foreign APIs are creating real and immediate dangers for American consumers seeking weight loss therapies.

What to know about cheaper, imitation weight-loss drugs

Off-brand versions of GLP-1 weight loss drugs made by compounding pharmacies are often more accessible, but not without risks.

Why OAC Warns Against Compounded GLP-1 Medications

I know first hand the benefits of GLP-1’s. With that being said, it remains OAC’s strong position that compounded GLP-1’s aren’t the answer until they meet our long-standing criteria for evidence based, FDA approved care. Our real worry is we’ve created an unequitable system of care for obesity. If you have great insurance, you get the highest level of care. If not, you get maybe safe/maybe effective care through compounding if you can afford the more modest fees and if you don’t have great insurance and can’t afford the more modest fees, you get no care at all. We are advocating for a world where people don’t have to make those compromises and all have care.

Resources

503A vs. 503B Pharmacies

When it comes to compounding pharmacies, all are not created equally. Here is an overview of the different designations and why that matters in the pharmaceutical industry today.

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