TOPIC: FDA Alerts Health Care Providers, Compounders and Patients of Dosing Errors Associated with Compounded Injectable Semaglutide Products
AUDIENCE: Patient, Health Professional, Pharmacy, Endocrinology
ISSUE: FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug.
Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports. Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and “units”) may have contributed to dosing errors.
FDA has received reports of dosing errors involving compounded semaglutide injectable products dispensed in multiple-dose vials.The majority 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. Most of the reports indicated that patients were unfamiliar with how to measure the intended dose using a syringe. 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.
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BACKGROUND: Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. There are currently three FDA-approved semaglutide products:
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WEGOVY injection is available as single-dose pre-filled pens that deliver a preset dose for once weekly dosing.
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OZEMPIC injection is available as multiple-dose pre-filled pens for single-patient use, designed for once-weekly dosing.
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RYBELSUS tablet is available as oral tablets for daily dosing.
The prescribing information for FDA-approved semaglutide injection contains information about overdoses that have been reported with other GLP-1 receptor agonists. Adverse effects include severe nausea, severe vomiting and severe hypoglycemia (low blood sugar levels). A prolonged period of observation and treatment for overdose symptoms may be necessary due to the long half-life of semaglutide of about one week.
FDA is aware of compounded semaglutide products that are being marketed for weight loss.
Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, quality or effectiveness. Compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved drug.
RECOMMENDATIONS:
- FDA encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide.
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FDA encourages health care 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.
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Additionally, health care providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available. If uncertain, health care providers should contact the compounder about calculating the correct dose of medication to prescribe or administer.
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