The FDA on Friday alerted healthcare providers and the public that it’s seeing reports of unintended overdoses of the compounded version of self-injected weight loss drug semaglutide, which can be manufactured by facilities that aren’t directly regulated by the federal agency.
The FDA cited several cases in which healthcare providers incorrectly calculated doses when converting from milligrams to units or milliliters, resulting in doses significantly higher than intended. Some of those patients experienced nausea and severe vomiting, the agency said. In some cases, people were hospitalized.
“The majority of the reports described patients mistakenly drawing up more than the prescribed dose from a multiple-dose vial during self-administration,” the FDA said. “In these instances, patients administered five to 20 times more than the intended dose of semaglutide.”
While the brand-name versions of semaglutide made by Novo Nordisk have captured the attention of the market and billions of dollars in sales, the Danish drugmaker hasn’t been able to meet the huge demand from patients. Because the product is in shortage, the FDA allows compounding pharmacies to make it, and health tech companies like Ro and Hims have started prescribing the compounded versions.
The FDA warning doesn’t provide details on who prescribed patients the compounded drugs where problems occurred, and the agency said it didn’t have that information when asked by Endpoints News.
A spokesperson for Hims, which prescribes only the compounded versions of GLP-1 weight loss drugs, told Endpoints that the clinicians it works with prescribe new patients doses that are consistent with or lower than the starting doses of brand-name versions, and that it provides ongoing support to patients to help make sure the drugs are used correctly. Ro didn’t immediately respond to a request for comment.
Drug compounders pose a higher risk than FDA-approved drugs due to a lack of premarket review, the FDA said, and the agency doesn’t track all of the compounders making semaglutide.
Novo has mounted a legal campaign against compounders, targeting some that it alleges are deceptively marketing their versions.
But the number of compounders has continued to grow, with Kaiser Health News reporting that at least 28 companies are now registered with the FDA to produce or distribute different versions of semaglutide. And about half of the companies have entered the market in the past 12 months.
The FDA said it’s unclear how safe or effective it is for compounders to mix additional ingredients, as the FDA is aware, with compounded semaglutide, including cyanocobalamin (vitamin B-12), pyridoxine (vitamin B-6), levocarnitine (L-Carnitine) and nicotinamide adenine dinucleotide (NAD).
The FDA in May 2023 also warned the public that compounded GLP-1 drugs like Ozempic and Wegovy may not include the same ingredients as the prescription medications.
Shelby Livingston contributed reporting.