The Food and Drug Administration (FDA) has issued a cautionary alert regarding the potential dangers associated with the use of compounded semaglutide, citing instances of individuals overdosing on these products. The agency highlighted that miscalculations in dosages have resulted in adverse symptoms such as nausea, vomiting, abdominal pain, and fainting, as stated in a statement released on July 26.
Semaglutide, a member of the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications, has garnered popularity for its benefits in weight management. While FDA-approved semaglutide products such as Ozempic and Wegovy are available in the form of single-dose prefilled pens for weekly injections, compounded semaglutide, lacking FDA approval, often necessitates individuals to measure and draw the medication from a vial prior to self-administration.
According to the FDA, dosing errors have arisen from both patients making measurement mistakes and healthcare providers inaccurately determining appropriate dosages. Reports indicated that many patients receiving vials of compounded semaglutide lacked experience with self-injections, leading to challenges in withdrawing medication from a vial into a syringe, coupled with confusion between different units of measurement like milliliters, milligrams, and ‘units.’
Compounded drugs, including semaglutide, are typically offered by facilities like medical spas, wellness and weight loss clinics, and pharmacies in scenarios where FDA-approved drugs are unavailable or cannot meet specific medical requirements. While compounded medications can offer tailored solutions for individuals with unique needs, they lack the FDA’s safety and quality evaluations.
The FDA underscored safety concerns related to compounded semaglutide, emphasizing that overdoses often stem from discrepancies in packaging and dosing requirements between compounded and FDA-approved products. Instances of healthcare providers incorrectly converting doses from milligrams to milliliters and patients misunderstanding proper dosage instructions have been highlighted as contributing factors to these overdoses.
To ensure safe usage of compounded semaglutide, experts advise individuals to only opt for such medications when medically necessary and under the guidance of a healthcare provider. It is crucial for patients to have a thorough understanding of the risks associated with compounded medications and to follow proper administration instructions meticulously to prevent adverse effects and potential overdoses. Vigilance for symptoms like nausea, vomiting, or abdominal pain following the use of compounded semaglutide is recommended, with immediate consultation with a healthcare provider in case of any concerns.
