Online sellers of compounded GLP-1 often do not mention the risks

A cross-sectional study indicated that many online sellers of combined GLP-1 receptor agonists may mislead customers.

Of 79 websites that sold a compounded GLP-1 agent, 11 (13.9%) failed to state that the drugs were compounded versions and seven (8.9%) incorrectly indicated they were generic drugs, says Alyssa Chen, MD, MSc. Public Health, from Yale University School of Medicine in New Haven, Connecticut, and colleagues detail it in a research letter in Gamma Health Forum.

Half of the sites (49.4%) failed to mention risks including adverse effects, warnings, precautions, and contraindications, and 40.5% reported an efficacy claim that was not present in the approved labeling of the FDA-approved brand-name GLP-1 agent.

A total of 34 sites (43%) reported that combination medications had not been approved by the FDA, while 29 (36.7%) reported that they were.

“Combined drugs contain the same active ingredients as brand-name drugs but may contain different inactive ingredients and are not approved by the FDA,” Chen’s group noted. “U.S. federal law requires that advertising for all prescriptions, including compounded drugs, be ‘truthful, non-misleading, and accurate;’ however, the extent to which compounded drug advertising meets this mandate is unclear.”

An estimated 11% of GLP-1 users They get their prescription through an online provider or website, so it’s important for online sellers to use advertising that isn’t misleading, they added.

But compounding pharmacies and their products “fall into a regulatory gray area.” Companion point of view Authors T. Joseph Mattingly II, PharmD, MBA, PhD, of the University of Utah School of Pharmacy in Salt Lake City, and Rena Conti, PhD, of Boston University.

“Because compounded products are copies of the original products, the pharmacy refers to the FDA-approved label that certifies safety and effectiveness, but unlike the originator, the pharmacy does not technically certify that they are manufactured in accordance with cGMP,” they explained. “Furthermore, unlike the original products, the 2002 product Thompson v. Western States Medical Center The Supreme Court decision ruled that an advertising ban on compounding pharmacies and their products is a violation of the First Amendment.

Mattingly and Conti added that while their ads may not necessarily be illegal, they appear to violate Congress’ intent to support patients’ access to safe and effective medications.

in Editor’s noteJulie Donohue, Ph.D., of the University of Pittsburgh, said it is “unclear” whether FDA regulations intended to apply to advertising by manufacturers should also apply to compounding pharmacies.

While compounders will not be able to make copies of GLP-1 agents as the shortage begins to resolve, resolving the shortage “will not prevent the questionable marketing practices of online pharmacies and others, nor will it resolve the illicit trade in counterfeit or adulterated products,” Mattingly and Conti said.

To better protect consumers, they recommended imposing more advertising requirements on vehicles, “aggressive” prosecution of counterfeiters, and establishing an independent task force to determine when to add or remove a drug from the drug shortage list.

Chen and co-authors initially reviewed 98 websites that sold GLP-1 agents from July through September 2024. Of these, 79 sold semaglutide (Ozempic, Wegovy, Rybelsus), or tirzepatide (Mounjaro, Zepbound). or liraglutide (Victoza, Saxenda). ) or a prescription for that. All websites sold compounded semaglutide, 72.2% sold compounded tirzepatide, and 3.8% sold compounded liraglutide.

A total of 52 websites (65.8%) showed a certification mark, 50 of which displayed LegitScript certification. Two websites did not offer prescriptions for combination GLP-1 medications and required a prior prescription.

All but one of the websites required physician involvement to obtain medication, and 63.3% required completion of a physician-reviewed questionnaire. Five websites required an in-person visit, eight required laboratory work, and 31 required a telehealth visit.

Including discounts, the average first-month price for combination drugs was $231 for semaglutide, $330 for tirzepatide, and $248 for liraglutide.

The researchers noted that because they reviewed all information contained on the websites, including subpages and linked blogs, there was a high probability that they overestimated the amount of information reviewed by average consumers.