Compounded Versions of Semaglutide Pose Risks Due to Dosage Errors
The Food and Drug Administration (FDA) has issued a warning regarding compounded versions of popular weight loss drugs, highlighting the risks of dosage errors that could lead to overdoses.
Compounded Semaglutide and Dosage Errors
The FDA alert mentions that patients have reported issues with measuring and self-administering compounded semaglutide injections incorrectly. Many patients lack experience with self-injection and have trouble withdrawing medication from a vial into a syringe. This confusion extends to units of measurement such as milliliters, milligrams, and units.
In some instances, compounding pharmacies have also miscalculated drug doses.
Advice for Healthcare Providers and Patients
The FDA urges healthcare providers and compounders to give patients the correct syringe size for the intended dose and to educate them on how to measure the dose accurately. Overdoses can lead to hospitalization with symptoms such as low blood sugar, nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones.
FDA-Approved Semaglutide Products
Currently, there are three FDA-approved semaglutide products available: Wegovy, Ozempic, and Rybelsus. However, due to high costs and limited access, many patients turn to cheaper compounded alternatives. These compounded drugs often come from online pharmacies, and their non-uniform containers and packaging add to the confusion.
Risks of Compounded Drugs
The FDA emphasizes that compounded drugs carry higher risks compared to FDA-approved drugs because they do not undergo the same rigorous premarket review for safety, quality, or effectiveness. Compounded drugs should only be used when a patient’s medical needs cannot be met by an FDA-approved drug.
Recommendations for Patients
Patients are advised to consult their healthcare provider or compounder about how to measure and administer the recommended doses of their medications.
The FDA’s warning highlights the importance of proper dosage and administration of compounded weight loss drugs. Patients should seek guidance from healthcare providers to avoid the risks associated with these medications.
References:
- FDA alert on compounded semaglutide injections and dosage errors
- FDA statement on risks of compounded drugs vs. FDA-approved drugs
- FDA-approved semaglutide products: Wegovy, Ozempic, and Rybelsus
