By Marina Zhang
Some patients have been self-administering incorrect doses of semaglutide, the active ingredient in Wegovy and Ozempic, two popular weight-loss and Type 2 diabetes drugs, the U.S. Food and Drug Administration (FDA) states in an alert on Friday.
As a result, some patients took five to 20 times the prescribed dose, with several requiring medical attention or hospitalization.
These patients administered compounded versions of the drug from compound pharmacies rather than drug manufacturers, the agency said.
Dosing errors may have occurred due to patients’ lack of experience with self-dosing, and some occurred due to doctors’ dosing miscalculations.
Reported semaglutide overdose adverse events include gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones, the FDA reported.
Incorrect Dosage
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 only available as a brand prescription with no approved generic versions. But since Ozempic and Wegovy are in shortage, 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.”
Most of the reports 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 wrote.
Some providers also miscalculated the dose when converting units.
One provider intended to prescribe a dose of 0.25 milligram or five units but prescribed 25 units instead, 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 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.
