Patients are being hospitalized with severe complications after accidentally overdosing on compounded semaglutide injections, the FDA has warned.
Reported adverse effects include gastrointestinal issues such as nausea, vomiting, and abdominal pain, as well as fainting, headaches, migraines, dehydration, acute pancreatitis, and gallstones.
These errors have arisen from patients measuring and self-administering incorrect doses, and healthcare providers miscalculating the appropriate dosages of the drug.
While the FDA recognizes the "substantial consumer interest" in using compounded semaglutide for weight loss, it has issued a cautionary warning about the significant risks involved.
Compounded semaglutide, the active ingredient in Ozempic and Wegovy, is a version of the drug that has been mixed with other medications or ingredients.
Compounded drugs can be useful in cases of medication shortages or when a drug needs altering to meet specific patient needs, such as removing an allergenic ingredient.
Due to the high demand for Ozempic, compounded versions of semaglutide have been rising in popularity. However, while Ozempic is FDA-approved, compounded semaglutide is not.
According to the FDA, compounded drugs pose a higher risk to patients because they lack rigorous testing and should only be used in cases of shortages or specific patient needs.
Many patients receiving compounded semaglutide vials report struggling with self-injections, according to adverse event reports.
Patients' lack of experience with withdrawing medication into a syringe and confusion over different units of measurement may have led to significant dosing errors.
For example, while Ozempic is dosed in milligrams, compounded semaglutide comes in various concentrations. Reports received by the FDA found that healthcare providers have often miscalculated doses when converting from milligrams to units or milliliters, resulting in patients receiving far more medication than intended.
The majority of the reports indicate that patients mistakenly drew and administered five to 20 times the prescribed dose from a multi-dose vial.
In one case, unclear dosing instructions from a telemedicine provider led a patient to search online for advice, resulting in the patient taking five times the intended dose.
Therefore, the FDA has strongly encouraged patients to consult their healthcare providers to ensure correct dosing. It has also urged healthcare professionals to be more diligent when prescribing and administering compounded semaglutide, emphasizing the need for improved counseling and support for their patients.
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