Following reports of adverse events, the FDA has issued an alert to healthcare providers, compounders and patients regarding dosing errors associated with compounded injectable semaglutide products.

Dosing errors have reportedly resulted from patients measuring and self-administering incorrect doses and healthcare providers miscalculating doses of the drug.

According to the adverse event reports, many of the patients who received vials of compounded semaglutide lacked experience with self-injections. Unfamiliarity with withdrawing medication from a vial into a syringe combined with confusion between different units of measurement may have contributed to dosing errors.

Most of the reports described patients mistakenly drawing up more than the prescribed dose from a multiple-dose vial during self-administration. In these instances, patients administered five to 20 times more than the intended dose of semaglutide.

Some patients sought medical attention or required hospitalization. Adverse events included gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.

The FDA encourages healthcare providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe.

Furthermore, healthcare providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available. If uncertain, healthcare providers should contact the compounder about calculating the correct dose of medication to prescribe or administer.

In conclusion, the FDA recognizes the substantial consumer interest in using compounded semaglutide products for weight loss. However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness or quality. Therefore, compounded drugs should only be used to meet a patient’s needs if the patient’s medical needs cannot be met by an available FDA-approved drug.