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- [00:01]
A
Support for this episode was provided by Eli Lilly and company. Thank you. Hello, I'm Aaron Lohr and this is the Endocrine News podcast. Technically known as glucagon, like peptide 1 receptor agonist, GLP1 drugs have been around for years for treating diabetes. Now it seems most people think of GLP1 drugs as medications to lose weight. And these medications are so popular that for a time supply could not meet demand, leaving many to seek compounded GLP1 medications which were more accessible and affordable. Compounded medications, however, are not FDA approved and there are questions regarding their safety and efficacy. And what do doctors and patients need to know when considering using compounded obesity medications? To help us answer these questions, our guest today is Dr. Michael Weintraub. Dr. Weintraub is an endocrinologist at NYU Langone Division of Endocrinology and he serves on the exam writing committee for the American Board of Obesity Medicine. It is always nice to welcome back a previous guest. Thank you for being here today, Dr. Weintraub.
- [01:21]
B
Thank you for having me.
- [01:23]
A
So let's start talking about compounded medicines. Can you tell us more about what they are and you give us a few examples of what they might look like?
- [01:30]
B
Sure. Compounded medications are defined by the FDA as combination or alteration of drug ingredients to create medications tailored to individual patient needs. Essentially, compounding is creating a medication not commercially produced by a pharmaceutical manufacturer. Some examples include liquid formulations of medications that might traditionally only be available in pill form, so it could be used in in children or patients who receive tube feeds. Those who have allergies to inactive ingredients in traditional preparations such as binding agents or dyes, a compounded formulation could remove or not include those. I recall actually, as an internal medicine resident, I frequently prescribed magic mouthwash for patients in the hospital with painful oral lesions or a GI cocktail for patients who had the dyspepsia. These are also examples of compounded medications.
- [02:29]
A
Can you tell us a little bit about the benefits and risks of compounded medicines?
- [02:34]
B
The main benefit is that the medication can be individualized to the patient's needs where a mass manufactured medication would not be suitable. When there's a drug shortage, compounded pharmacies can pick up the slack. The FDA allows for compounded preparations of the medications in the setting of a designated shortage. An example of this was actually during the COVID pandemic pandemic when there were a lot of supply shortages, including for commercially available drugs. The FDA temporarily relaxed these restrictions on compounding pharmacies so that compounded preparations could be given to patients. A principal risk is the lack of FDA oversight in the preparation process of these medicines when they are created in compounding pharmacies. Oversight of mass manufacturers of pharmaceuticals falls under a well established federal FDA regulation. But the fda, FDA does not oversee or perform any quality control to individual compounding pharmacies and this has led to issues in the past. Compounding pharmacies have been linked in the past to sterility issues and even infection outbreaks.
- [03:45]
A
You mentioned one benefit of compounded medicines is that they may be more available when other medicines are in short supply. So how available are obesity drugs like semaglutide and tirzepatide today?
- [03:56]
B
The beginning of the supply shortage for GLP1 medicines occurred shortly after the FDA approved semaglutide for the treatment of obesity in mid-2021. The pharmaceutical manufacturer could not ramp up production of the peptide to meet this surge in demand, and the fda, which monitors regularly for drug shortages, placed semaglutide in the drug shortage list in March of 2022, and so that allowed for compounding pharmacies to produce the medication. However, fortunately in the last year, these shortages have largely resolved. The FDA removed tirzepatide from the shortage list in December of 2024 and removed semaglutide from the drug shortage list in February of 2025. And you know, thankfully I haven't had patients have any issues attaining these medications due to shortages for many months.
- [04:49]
A
So what does the current landscape look like regarding compounded obesity medicines? Like what's out there and how many people are using them?
- [04:56]
B
There's an estimate that 2 million people received compounded semaglutide in the United States in 2024, which is a conservative estimate according to the Outsourcing Facilities Association. So this seems to be quite prevalent. And if you go on social media, you'll see dozens of Companies advertising compounded GLP1 medications with varying specificity. Some will advertise it as semaglutide or a semaglutide salt. Others will advertise medications that are still in clinical trials and they're not even FDA approved. And other companies will even advertise compounded GLP1 injection without any more specificity other than saying that it's a custom formulation.
- [05:40]
A
That does raise a few concerns for me and probably others. How do compounded obesity medicines rate when it comes to safety and efficacy?
- [05:49]
B
There's been statements from several organizations that compounded versions of semaglutide and tirzepatide are not what they're advertised to be. These are statements from the Obesity Society, Obesity Medicine association, among others. Products might contain the same active ingredient as the FDA approved semaglutide, but others might contain semaglutide in salt forms. In research, chemicals are those core formulated with supplements. So these particular formulations, they could be safe and effective, but we don't know because that's not what was evaluated in the clinical trials. There have been some studies that have tested compounded formulations, and these studies have found up to a difference of 40% of drug content relative to what is advertised. And these studies have measured purity and found a fraction of what was indicated on the label. Another confusing aspect of compounded formulations is the lack of direction on how to inject the correct dose. The dosing and titration instructions can often be complicated. It might be instructions given in milliliters or units of insulin or milligrams, and they might include these complex conversion charts. They might include a syringe that could vary in size depending on which batch, or might not even provide one. And some formulations are actual powders, so they require the patient to basically be the compounding pharmacy themselves to reconstitute the medication. So this can lead to a lot of confusion on the patient perspective and then providers can be unequipped to really offer the correct guidance. There's been a rise in poison control calls in ED visits for overdoses of GLP1s on the order of 1,500% since 2019. And the odds of preparation errors for compounded formulations has also been looked at. So according to analysis of the FDA Adverse Event Reporting System, comparing the compounded formulation to the manufactured preparation, There is a 49% increase in the rate of or odds of preparation errors. That also translated to higher risk of harm. There was a three times higher rate of complications like symptoms like abdominal pain, three times the rate of hospitalization and risk of cholecystitis.
- [08:11]
A
That's quite a lot of risks and some concerns. And yet there's probably still some people out there who are looking to use these. So what do doctors and patients need to know when considering possibly using compounded obesity medications?
- [08:29]
B
So now that supply shortages have largely resolved, the reason that patients are turning towards compounded medications is cost. You know, one could think that the advantage for compounded products to exist is that it increases access and thus it increases equity. Those who don't have insurance coverage or lack of the ability to pay the high out of pocket costs for the pharmaceutical medicines can at least still obtain a Medicine. This democratizes access by making it affordable to a large portion of the population who could medically benefit from a GLP1. But I would regard this as a false equity. Patients getting compounded formulations are actually, you know, receiving inferior care. You know, based on the studies that I just mentioned, they're getting medicines that are unverified and have a higher potential for adverse effects.
- [09:19]
A
Let's think about the future for a moment. What is the downstream medical impact of using concomitant obesity medicines?
- [09:27]
B
Obesity is a chronic disease, so it requires chronic treatment. If patients attain compounded medications and have less guaranteed effectiveness, purity or risk of side effects, this can lead to patient confusion and then they might discontinue the medication and discontinue care. And that could ultimately lead to worse long term health outcomes. The expansion of this compounded obesity medicine market has really diverted the focus from the primary issue. And the primary issue is the high cost of these medicines and the lack of insurance coverage. And this is, I think, where we should be focusing our efforts. My hope is that this problem will, in the medium term or long term, solve itself. Very recently, pharmaceutical manufacturers have released statements that they will be lowering the out of pocket costs of these medicines. There's also potential legislation that could further expand insurance coverage to those with Medicare. And there's a huge pipeline of agents in development that will add for market competition and ultimately lower costs. So. So we soon could attain what I would call truly equitable access, both affordability and safety, so full, comprehensive care can be delivered to our patients.
- [10:45]
A
Well, Dr. Weintraub, I think in a short amount of time we've covered a lot of territory and it's nice to think about some bright spots in the future with increased access, increased affordability and increased safety. Thank you so much for taking time and being with us here today.
- [11:00]
B
Thank you.
- [11:03]
A
And that's all for this episode. I hope you enjoyed it. If you'd like to hear more about obesity, I invite you to explore the March 2025 obesity issue of Endocrine News, where you'll learn more about treating obesity across the lifespan, making obesity treatment more effective and accessible, and protecting future generations from obesity. We'll link to the issue in today's episode description. We'll be back soon soon with another fascinating dive into the world of endocrinology. Until then, thanks for listening. Endocrine News podcasts are a free service of the Endocrine Society. To learn more or to become a member, visit the society's website at www.endocrine.org.