Researchers wanted to better understand the accuracy of advertising practices behind websites selling compounded GLP-1 RAs.
Websites selling compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) misinformed customers by inaccurately promoting efficacy, safety, and FDA approval for available products, according to data published in JAMA Health Forum.1
“High global demand for [GLP-1 RAs] and dual gastric inhibitory polypeptide [GIP]/GLP-1s has exceeded manufacturers’ supply, leading to medication shortages that have persisted since 2022,” wrote authors of the study. “Medication shortages allow pharmacies to sell compounded versions of [FDA-approved] drugs, including GLP-1s.”
While avoiding medication shortages is a top priority for many parties within the pharmaceutical supply chain, if they are to arise, pharmacies are then able to sell compounded versions of the drug under shortage. With GLP-1 RAs under shortage for over 2 years, along with a spike in demand as more GLP-1 RA indications are approved, several online distributors have looked to cash in by selling non-FDA-approved, compounded versions of GLP-1 RAs like semaglutide (Ozempic), tirzepatide (Mounjaro), and liraglutide (Victoza).1
“Compounding a copy of an FDA-approved product would ideally follow a U.S. Pharmacopoeia (USP) monograph or other standard to ensure product quality. However, USP monographs for most GLP-1 RAs and the dual GIP/GLP-1 RA therapies are currently unavailable to guide standard compounding,” wrote the American Diabetes Association.2
READ MORE: Q&A: Factors Showing Tirzepatide is More Beneficial Than Semaglutide | ASHP Midyear
The act of compounding medications has shown to be a saving grace in times of manufacturer shortages and increased patient demand. Undermining FDA and USP guidelines, however, several online entities have since attempted to take advantage of this boom in demand for GLP-1 RAs.
Highlighting the need for appropriate advertising of compounded medications, researchers noted that 11% of all patients using GLP-1 RAs purchased them from an online website.1 Along with previously noted advertising that was misleading, researchers investigated advertising tactics of online compounded GLP-1 RA sellers and the extent in which consumers were misled when purchasing them.
Between July and September 2024, researchers conducted online searches of websites advertising the sale of compounded semaglutide, tirzepatide, and liraglutide. They searched by brand name and generic, and noted the location, medications sold and associated prices, compounding disclosures, efficacy and safety claims, use of brand names, and clinician involvement of each website’s products.1
Before presenting advertising tactics, researchers found that all 79 websites included in the study sold compounded semaglutide, 57 (72.2%) sold compounded tirzepatide, and 3 (3.8%) sold compounded liraglutide. Furthermore, the median first-month price was $231 for semaglutide, $330 for tirzepatide, and $248 for liraglutide.
“Eleven websites (13.9%) did not disclose the GLP-1 RAs for sale were compounded, while 7 (8.9%) referred to compounded medications as generic. While 34 websites (43.0%) stated the compounded medications were not FDA approved, 29 (36.7%) stated or implied these drugs were FDA approved. Thirty-nine websites (49.4%) did not report adverse effects, warnings and precautions, and contraindications of compounded GLP-1 RAs, whereas 32 (40.5%) advertised an efficacy claim not in the authorized label of the FDA-approved branded GLP-1 RA,” continued the authors.1
By exploring every existing website that sold compounded GLP-1 RAs during the study period, researchers uncovered a significant amount of misinformation being relayed to potential users of these medications. Across all notable data, at least 35% of all included websites disseminated some type of misinformation regarding GLP-1 RAs.
While the same websites partially advertised their products appropriately, these findings highlight the severe caution needed when purchasing GLP-1 RAs from online entities. But until these websites receive regulatory oversight and are forced to disseminate appropriate advertising, patients may have a hard time heeding the warnings of non-approved GLP-1 RAs because of their life-saving indications for diabetes, cardiovascular disease, and obesity.
“Enhanced regulatory guidance and oversight are needed to clarify criteria for ‘truthful, non-misleading, and accurate’ advertising to ensure consumers are informed of the risks and benefits of compounded GLP-1 RAs and other compounded medications. The FDA could require websites to explicitly disclose and define compounding, including lack of FDA approval; institute unique naming conventions for compounded medications; and be given greater authority to act against misleading compounded medication advertising,” concluded authors of the study.1
READ MORE: Oral GLP-1 Shows Significant Weight Loss in Patients With Obesity
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Q&A: How Specific GLP-1s Impact Different Patient Populations | ASHP Midyear
Jennifer Clements, PharmD, BCACP, BC-ADM, BCPS, CDCES, FADCES, FCCP, discussed current GLP-1 medication offerings and how each impacts patients differently.