FDA Issues Alert About Overdosing on Weight-Loss Drug After Some Take 5 to 20 Times the Intended Dose

Semaglutide is the active ingredient in popular injectable weight-loss drugs.

Joel Sage/AFP via Getty Images

Some patients have been self-administering incorrect doses of semaglutide, the active ingredient in popular weight-loss and Type 2 diabetes drugs Wegovy and Ozempic, and overdoses may be related to “adverse events, some requiring hospitalization” reported to the U.S. Food and Drug Administration (FDA), the agency warned in a July 26 alert.

In some cases, patients took five to 20 times the prescribed dose, according to the alert. These patients administered compounded versions of the drug from compound pharmacies rather than drug manufacturers, the FDA said.

Dosing errors may have occurred because of patients’ lack of experience with self-dosing, and some occurred because of doctors’ dosing miscalculations, according to the agency.

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Some patients sought medical attention or required hospitalization after the medication error, the FDA reported.

Reported semaglutide overdose adverse events include gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones, according to the agency.

Incorrect Dosages

The new alert comes months after the FDA warned about compounded semaglutide drugs being marketed for weight loss and to treat Type 2 diabetes.

Currently, semaglutide is available only as a brand-name prescription, with no approved generic versions. But because there is a shortage of Ozempic and Wegovy, compounders may prepare a compounded version of the drug if they meet certain requirements.

However, the FDA said, these versions differ from approved semaglutide drugs, as compound drugs “do not undergo FDA premarket review for safety, effectiveness, or quality.”

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Most of the reports of dosing errors came from patients who were unfamiliar with measuring the intended dose and who overdosed while using a multidose syringe.

Patients were instructed to administer five units, or a 0.05-milliliter dose, but drew up 0.5 milliliters (50 units) of semaglutide instead.

“In one reported case, it was difficult for the patient to obtain clarity on dosing instructions from the telemedicine provider, who prescribed the compounded semaglutide, leading the patient to conduct an online search for medical advice and resulting in the patient taking five times the intended dose,” the FDA stated in its alert.

Some providers also miscalculated the dose when converting units.

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One provider intended to prescribe a dose of 0.25 milligram or five units but instead prescribed 25 units, leading patients to experience severe vomiting.

Another provider prescribed 20 units instead of two, inducing nausea and vomiting in three patients.

Compound Drugs May Contain Other Ingredients

Some compounders incorporate additional ingredients, such as cyanocobalamin (vitamin B12), pyridoxine (vitamin B6), levocarnitine (L-carnitine), and nicotinamide adenine dinucleotide (NAD), into their semaglutide compounds.

The FDA has also received reports that, in some cases, the compounder may use salt forms of semaglutide, such as semaglutide sodium or semaglutide acetate. The salt forms are active ingredients different from those used in the approved drugs, which contain the base form of semaglutide.

The FDA said it is unaware of any basis for compounding using the salt form.