FDA Warns of Dosing Errors with Compounded Semaglutide Injectables

The FDA has issued a warning about dosing errors and subsequent adverse events related to compounded semaglutide injectable products. These errors have led to some patients being hospitalized due to overdoses. These issues primarily stem from patients and healthcare providers miscalculating or incorrectly administering the drug.

Compounded semaglutide products, unlike the US Food and Drug Administration (FDA)-approved ones, can vary widely in strength and packaging, making it easy for mistakes to happen.

Instructions often use “units” instead of milligrams or milliliters, causing confusion. Some patients have accidentally taken five to 20 times the recommended dose, resulting in severe side effects like intense nausea, vomiting, low blood sugar and dehydration. Many patients struggle with withdrawing the medication from a vial into a syringe, leading to overdoses, especially if they’re not used to self-injecting.

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The FDA urges patients to consult their healthcare providers or compounders for proper guidance on measuring and administering the correct dose. Healthcare providers and compounders are also advised to supply the appropriate syringe size and educate patients on its use.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, structurally similar to human GLP-1 that lowers blood glucose and promotes weight loss. It’s available in three FDA-approved forms: Wegovy and Ozempic, which are injections, and Rybelsus, an oral tablet. These approved forms come with pre-measured doses, making them easier to use and lowering dosing errors.

Healthcare providers should be careful when prescribing and administering compounded semaglutide. If they’re unsure about the correct dose, providers should contact the compounder for clarification.

The FDA notes that compounded drugs, including those containing semaglutide, pose higher risks because they do not undergo the rigorous premarket review for safety, quality and effectiveness that FDA-approved drugs do. They should only be used when an FDA-approved drug cannot meet a patient’s medical needs.

Novo Nordisk, the maker of FDA-approved semaglutide products, intensified legal actions in May — filing 21 lawsuits — against various entities selling unsafe compounded versions of the drug. Recent tests by Novo Nordisk found that some compounded drugs contained no semaglutide and up to 24 percent impurities.