Poison control centers report rise in calls tied to unapproved GLP-1 drugs

California's poison control system says it keeps getting calls from people who became sick — and in some cases were hospitalized — after taking GLP-1 drugs, many of them compounded products the Food and Drug Administration has not approved ^[1]. The FDA says unapproved versions do not get the same federal review for safety, effectiveness and quality before they reach patients ^[1].

Compounded GLP-1 medications are mixed versions of brand-name drugs such as Ozempic, whose active ingredient is semaglutide. They were first made to fill a drug shortage or to meet an individual patient's medical need, the FDA says ^[1]. The shortage of GLP-1 medications is over, but safe-medicine advocates say compounded versions are still being mass produced and flooding the market ^[1].

The FDA has publicly warned about telehealth companies that claim compounded drugs are the same as FDA-approved products ^[1]. Warning signs it lists include large discounts that seem too good to be true, no instructions with the product, and no screening by a licensed doctor ^[1]. A Benzinga report on the FDA's warning covered concerns about fraudulent and mislabeled GLP-1 medications ^[2].

Shawn Rose, then living in Chicago, said his insurance denied coverage of a GLP-1 weight-loss prescription in January and his primary doctor suggested telehealth ^[1]. He downloaded the app of Mochi Health, a San Francisco-based telehealth company, paid about a couple hundred dollars a month and began receiving shipments of compounded semaglutide, he said ^[1]. He estimated the price was about a 75% saving compared with a doctor's office ^[1]. Rose said the first vial "seemed to go okay," but after his dose was increased he was rushed to an emergency room within about an hour to an hour and 15 minutes. Medical documents he provided showed multiple hospital visits, and he said he could not hold down food or water ^[1]. "I got so sick and there was a part of me that just thought I was going to die from it," he said ^[1].

Rose said Illinois state regulators are looking into his case and his complaint against a Mochi nurse, who he said replied in the company's app, "I'm sorry to hear that Shawn. Good luck to you" ^[1]. He also said he received vials with no labels. "I don't know what I'm taking. I have no idea," he said ^[1].

In June, the NBC Bay Area Investigative Unit reported on Mochi Health and the closure of a pharmacy it used in Washington state, after investigators there found the pharmacy allowed and even directed untrained pharmacy assistants to compound GLP-1 drugs ^[1]. Regulators also found unlicensed workers handling prescriptions and expired medications about to be shipped to patients ^[1]. Neither the pharmacy nor Mochi Health responded to repeated calls about the findings ^[1].

Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, said "there's rarely any consequence for the harm onto patients that's been done by the telehealth company" ^[1]. He said telehealth companies are "just doing it as a money grab," and that compounded medicines are not made under the same safety regulations as FDA-approved drugs ^[1].

Since last year, Safdar's group has tracked 50 actions by state boards of pharmacy against compounders operating unsafely, including probation and license revocations, and 160 letters from the FDA to telehealth companies and compounders warning about deceptive marketing ^[1]. Safdar said warning letters are "only the start of the conversation about enforcement" and that not enough cases are referred to the Department of Justice ^[1]. The FDA said it "will continue to take action, where appropriate, to protect public health" ^[1]. The American Telemedicine Association called the problem "not a telehealth issue, it's a bad actor issue" ^[1].

Why it matters for patients

Approved GLP-1 drugs such as Ozempic, Wegovy and Rybelsus (semaglutide), and Mounjaro and Zepbound (tirzepatide), go through FDA review for safety, effectiveness and quality. Compounded versions do not ^[1]. That means the amount of drug in a vial, how it was made and how it is labeled can differ from an approved product, and patients may have less information about what they are receiving ^[1]. Rose's account describes vials with no labels ^[1].

The FDA's warning signs focus on how a product is sold: prices far below the usual cost, no instructions, and no screening by a licensed doctor ^[1]. State pharmacy boards and the FDA are the bodies that have taken action so far, with 50 pharmacy board actions and 160 FDA warning letters since last year ^[1]. It has not been reported how many poison control calls have been logged nationally, which products or ingredients were involved in specific cases, or whether any company has been found legally responsible. The FDA has not announced new rules or recalls in this reporting, and no timeline for further enforcement action has been disclosed ^[1].