Compounded Medicines: What You Need to Know

Here’s Why Some People Are Turning to Compounded Medicines and What the Medical Professionals Have to Say About It

Browse through virtually any popular weight loss website or social media feed these days, and chances are you will come across someone talking about semaglutide medications. But as these drugs have grown in popularity and demand for them continues to surge, pressure on the supply chain has caused limited availability—prompting some to turn to alternate versions, including unapproved compounded products.

Here we take a closer look at what differentiates compounded versions from traditional semaglutide medications and what the medical professionals have to say about it.

What Is Semaglutide?

Semaglutide belongs to a class of medications known as GLP-1 receptor agonists and traditionally has been used in conjunction with a sound diet and exercise program to control blood sugar levels in adults with type 2 diabetes.

It works primarily “by assisting the pancreas to release the right amount of insulin when blood sugar levels are high,” which allows it to help move sugar out of the blood and into other body tissues where it can be used for energy. GLP-1, a hormone naturally produced in the gut, plays a critical role in regulating appetite and food intake.

Two commonly known brand names of the medication are Ozempic® and Wegovy®. Developed by Novo Nordisk, semaglutide was first approved for use in 2017 and, based on clinical trials, subcutaneous semaglutide has been approved in Canada, Europe, the UK, and the USA for chronic weight management in those who have weight-related conditions or are obese.

The Role of Semaglutide in Weight Loss

Along with its well-documented success in treating type 2 diabetes, semaglutide was more recently approved by the US Food and Drug Administration for chronic weight management. This marks it for use as an anti-obesity medication for those with a body mass index (BMI) over 27 and/or those with health conditions such as type 2 diabetes, high blood pressure, or dyslipidemia, which are connected to or a direct result of being overweight.

In addition, semaglutide slows the movement of food through the stomach, resulting in a sensation of fullness for longer periods of time, curbing the appetite. Semaglutide does this by binding to specific receptors in the body to trigger the release of the hormone glucagon-like peptide-1 (GLP-1). And while its ability to promote insulin production and reduce blood sugar made it an appealing choice to treat diabetes, studies have found that the drug also influences appetite by making you feel “full” and therefore suppressing hunger.

An Obesity Epidemic

The National Institute of Diabetes and Digestive and Kidney Diseases’ website reports that obesity affects more than 4 in 10 adults in the US, with nearly 1 in 10 Americans suffering from severe obesity. These numbers are backed up by the CDC, which puts the percentage of adults aged 20 and older with obesity at 41.9%, with that number climbing to 73.6% when including those who are overweight.

With numbers like this—and many more people who may not necessarily fit the eligibility criteria lining up to take the drugs—is it any wonder why and how alternative medications have found their way into the mix (or that physicians are growing increasingly concerned about their safety)?

Demand for Semaglutide Creates Grey Zone for Meds

Blame social media, an e-commerce boom, or the simple, quick ease of access to medications through illegitimate websites—people are gaining access to semaglutide (or what they believe to be semaglutide) through several questionable or even illegitimate sources. And that’s a problem for more reasons than one.

Not only are people who don’t fit the eligibility criteria trying to get their hands on the medication, but in going through unregulated channels, they are exposing themselves to the possibility of paying for placebos, or worse.

In a recently published article in Time, the magazine reported that, in addition to some online sellers touting knockoffs of Wegovy® that may not even contain semaglutide, Novo Nordisk, the original developer of semaglutide, is suing several medical spas, weight loss clinics, and compounding pharmacies in the U.S. for “selling unapproved versions of its brand-name drugs, made with versions of semaglutide that the FDA does not sanction”.

Compound Medications and Unapproved Versions

The first and most obvious question is simple. What is a compound medication? Simply put, compounds are a combination of two or more ingredients used to create a medication. But there are other differentiators as well.

Commercially available drugs that are available at your pharmacy are not only FDA-approved but also made in an FDA-regulated lab. This minimizes chances for any potential contamination or error and maximizes the consistency of quality you would expect from an FDA-approved medication.

Compound pharmacies, on the other hand, can create an altogether different dose of a drug or add, remove, or even substitute ingredients. In certain cases, this can be beneficial—modifying a medication to exclude a specific ingredient that someone is allergic to, for example—but because the FDA doesn’t review them for safety or efficacy (compounding pharmacists aren’t required to receive authorizations from the FDA to produce medications) there is always the potential for the compound medication to differ vastly from its approved counterparts.

FDA ISSUES WARNING TO PATIENTS ABOUT COMPOUNDED SEMAGLUTIDE

An up-to-date warning has been issued by the FDA concerning medications containing semaglutide marketed for type 2 diabetes or weight loss after the agency received adverse event reports from patients who used compounded semaglutide.

In it, the FDA reiterated they do not review compounded versions of these drugs for safety, effectiveness, or quality and that they have received reports that some compounders are using salt forms of semaglutide, which are different active ingredients than what is currently approved.

How to Ensure the Safety of Your Semaglutide Medications

To avoid potentially harmful side effects and ensure the safety of your semaglutide medication, always obtain it from a reputable, trustworthy source.

Physician-led weight loss teams like ours here at eMed provide a safe path to successful weight loss. Your health and well-being is our priority number one and always will be. By ensuring your access to FDA-approved weight loss medications and monitoring your progress, we give you the tools you need to lose weight safely—and keep it off for good.

Sources:

MedlinePlus, an official website of the US government.
Science Direct, Trends in Cardiovascular Medicine. Semaglutide for the treatment of obesity.
Scientific American, 5 Ways Ozempic and Other New Weight-Loss Drugs Have Changed Health.
BMI+ Doctors, Exploring the Obesity Epidemic and Semaglutide’s Promising Role.
Diabetes, Obesity, and Metabolism, Semaglutide for the treatment of overweight and obesity: A
review.
National Institute of Diabetes and Digestive and Kidney Diseases, Prescription Medications to Treat Overweight & Obesity.
Time Magazine, What You Need to Know About Compounded Versions of Popular Weight Loss Drugs.
US FDA, Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss.