Online advertising for compounded versions of a popular class of type 2 diabetes and weight-loss medications commonly includes practices that only partially inform or even misinform consumers, a team of Yale School of Medicine (YSM) researchers has found. The work was published in January as a research letter in JAMA Health Forum.

Compounding pharmacies have historically created custom medications for individual patients. But with a shortage of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) since 2022, the U.S. Food and Drug Administration (FDA) has allowed compounding pharmacies to make and sell their own versions of the drugs. Online outlets for these compounding pharmacies have since proliferated, and a recent poll found 11 percent of people taking the medications got them from an online provider or website.

Unlike with FDA-approved brand-name drugs or generic drugs, the FDA does not verify the safety, efficacy, or quality of compounded drugs. Federal regulations for advertising compounded drugs are less stringent than for FDA-approved drugs, though all prescription drug promotion by a manufacturer must be “truthful, non-misleading, and accurate,” according to the FDA’s web page on compounding and the agency.

But exactly what that means for compounded drugs isn’t clear, said Alissa Chen, MD, MPH, a postdoctoral fellow and the last author of the research letter. The high global demand for the drugs has created “this unprecedented scenario with a lot of advertising in a very open space,” she said.

For the study, the team performed online searches from July to September 2024 to find websites selling compounded semaglutide, tirzepatide, or liraglutide. Of the 79 pharmacies found, 13.9 percent did not disclose the medications for sale were compounded, and 36.7 percent claimed or implied the drugs were FDA approved. Nearly half the sites did not report harmful effects, warnings, precautions, or contraindications, and 40.5 percent claimed efficacy for something not in the label of the FDA-approved branded drugs.

“Our paper tried to understand how compounding websites are acting within this landscape of little oversight, and one of the big takeaways is the current landscape allows for free rein of advertising practices,” said Ashwin Chetty, an MD candidate and the letter’s first author.

Chen said the most surprising finding to her was “that so many of the websites were advertising something like reduced hair loss or improved sexual function when truly there's not substantial data to suggest that those are benefits that can be achieved by a GLP-1 RA.”

The advertising practices are problematic for patients, according to Reshma Ramachandran, MD, MPP, MHS, assistant professor of medicine (general medicine) and a co-author. Patients often seek out compounded versions of the medications because the brand-name versions are expensive, she said. FDA approval provides reassurance that products have been tested for safety and efficacy, and compounding pharmacies “obscuring the fact that the versions they sell have not been vetted by the FDA misleads patients,” she said. “Making unclear that their drugs are untested and unregulated might lead to potential harm.”

The researchers hope their findings inform regulatory policy changes for compounded drugs’ advertising to protect consumers, said Joseph Ross, MD, MHS, professor of medicine (general medicine) at YSM and of public health (health policy and management) at the Yale School of Public Health and a member of the team.

“This study is a good example of examining an area of health care delivery where regulatory policy is less clear,” he said. “I’m hopeful that our findings can be used by the FDA to ensure fair and appropriate advertising by websites selling compounded GLP-1 RAs.”

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