Food and Drug Administration (FDA)-approved glucagon-like peptide-1 receptor agonists (GLP-1) anti-obesity medications, such as Zepbound® and Wegovy®, are flying off pharmacy shelves. The medications require a prescription and are an effective treatment option for type 2 diabetes and obesity.
“These medications were first used in diabetes management because GLP-1 causes the release of insulin, which helps control blood sugar,” says Muhammad Feteiha, MD, general and bariatric surgeon at Atlantic Health System and board certified in Obesity Medicine. “The medication was found to also result in weight loss, and it is now FDA-approved for the treatment of diabetes and obesity management.”
Due to a shortage of these popular medications, compounding pharmacies were temporarily authorized to manufacture and sell GLP-1 drugs. These compounded drugs, which are not approved by the FDA, have some safety concerns. Dr. Feteiha says there is no longer a shortage of the brand-name medications, so the FDA has ordered compounding pharmacies to stop producing their versions of these medications.
GLP-1 Medications 101
Dr. Feteiha explains that GLP-1 is a naturally occurring hormone that affects your brain’s hunger center. When you eat, GLP-1 is produced by your intestines to help you feel full, but we normally don’t have high levels of GLP-1 circulating in our bloodstream. The GLP-1 medications mimic the action of GLP-1 release, resulting in a decreased appetite and feeling full after eating smaller amounts of food.
What are compounded medications?
Compounding pharmacies fill prescriptions much like your neighborhood CVS or Walgreens. They can be helpful if you struggle to swallow pills and prefer a liquid, or if you need a specific formulation of your medication that’s not available from the drug manufacturer.
When there is a widespread shortage of a medication, compounding pharmacies are authorized by the FDA to mix and sell medications to meet consumer demand. In instances where the drug manufacturer has authorized a generic version of a medication, pharmacists can use that formulation to make the drug.
In instances where a generic version of a drug does not exist, such as with GLP-1 medications, the formulation is patent-protected. This means consumers do not receive the FDA-approved version of the drug and the ingredients may not match the trademarked drug’s formula.
“Compounded medications can contain added or different ingredients from the original formulation,” says Victoria Williams, APN, nurse practitioner at Atlantic Health System. “There are concerns about the possible use of expired ingredients, incorrect dosing information and counterfeit products.”
Are compounded weight loss medications safe?
The primary concern with compounded medications is quality control and effectiveness. Medications are rigorously tested before they become FDA-approved for consumer use. Years of research on the safety and effectiveness of the drugs is required. The FDA also inspects the facilities where the drugs are manufactured to ensure rigorous and consistent formulations.
“Beginning in 2022, the FDA allowed compounding pharmacies to produce compounded versions of GLP-1 medications,” says Dr. Feteiha. “The issue is that these pharmacies make versions of the medication that are neither FDA-approved nor inspected.”
How to get safe GLP-1 medication
If you are concerned about the price of your GLP-1 medication, Williams suggests contacting the manufacturer or visiting their website to ask about coupons or cost-saving programs, which are often available.
“Some online retailers charge much less for compounded GLP-1 medications. However, if it sounds too good to be true, it probably is,” says Williams. “I would encourage anyone filling a prescription for these medications to use a licensed retail pharmacy that dispenses medications manufactured in an FDA-approved facility.”
They should also ensure that they are seeking treatment with a provider who has expertise in prescribing weight loss medications and obtain the name brand medications. Patients taking weight loss drugs, including GLP-1 medications, need to be seen and monitored on a frequent basis.
“Obesity is a complex, multisystem disease that requires in-depth lifestyle and behavioral modification along with medical and sometimes surgical management,” says Dr. Feteiha. “Even though these drugs are remarkable, there are no magic bullets in treating diabetes or obesity.”
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