People are overdosing on the compounded versions of semaglutide drugs like Ozempic and Wegovy, the U.S. Food and Drug Administration said Friday.
The two FDA-approved semaglutide injection products come as single-dose, pre-filled pens to be taken once weekly. But the compounded versions of the semaglutide injectables are self-administered, can come in multiple-dose vials, have differing concentrations or come with confusing instructions, like telling users to inject in "units" rather than more precise milligrams or milliliters, the FDA said.
These varying factors may be confusing for patients who are measuring and administering the compounded injections themselves, and for the health care providers who are prescribing or dispensing them, resulting in dosing errors that can lead to overdoses.
In an alert on Friday, the FDA said it had received adverse reports, including some requiring hospitalization, in which patients mistakenly injected themselves with 5 to 20 times more than the intended dose of semaglutide.
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Most of the reports showed the patients didn't know how to withdraw the medication from the vial into a syringe and inject themselves, per the agency. But other overdoses were the result of health care provider mistakes, like one case affecting three patients in which 20 units were prescribed instead of 2.
The overdose reports described severe symptoms like nausea, vomiting, fainting, migraine, dehydration, low blood sugar, acute pancreatitis and gallstones. And because of the one-week half-life of semaglutide products, the symptoms could last a while, requiring a prolonged observation period, the FDA said.
Though semaglutide medications were originally prescribed to treat Type 2 diabetes, the side effect of weight loss has led to a spike in demand, which is straining the supply. Plus, costs of around $1,000 out-of-pocket for monthly doses of the FDA-approved drugs make alternatives an enticing idea: Enter, the less expensive and more readily available compounded semaglutide injectables.
But however enticing the idea might be, federal health officials have warned against compounded forms of semaglutide partly because they don't undergo its review process for safety, quality and effectiveness, meaning they pose a high risk of adverse effects. And last year, the FDA said some may be created with salt substitutes instead of the same active ingredient in FDA-approved products.
In its latest alert, the FDA said only the patients "whose medical needs cannot be met" by its approved semaglutide drugs should be using the compounded versions.
The agency urged health care providers and compounders to ensure patients have the correct syringe size and dose and that they teach patients how to self-administer the injection. It also requested providers become aware of the different concentrations available and dispensed in the compounded semaglutide market.
