The FDA has issued a warning about numerous adverse events, including hospitalizations, stemming from dosing errors and overdoses of compounded semaglutide injectable products, underscoring the risks posed by non-FDA-approved variations.

These errors often stem from patients incorrectly measuring and self-administering doses and healthcare providers miscalculating doses.

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Novo Nordisk A/S's (NYSE:NVO) 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:

• Wegovy injection is a single-dose prefilled pen that delivers a preset dose for once-weekly dosing.
• Ozempic injection is available as multiple-dose prefilled pens for single-patient use, designed for once-weekly dosing.
• Rybelsus tablets are available as oral tablets for daily dosing.

Mistakes often involved unfamiliarity with drawing medication from a vial into a syringe and confusion over different units of measurement such as milliliters, milligrams, and "units."

"Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports," the FDA said in a July 26 statement.

The prescribing information for FDA-approved semaglutide injections includes overdose risks, such as severe nausea, vomiting, and hypoglycemia, which may require prolonged observation and treatment due to the drug's long half-life.

FDA has noted compounded semaglutide products marketed for weight loss, which pose higher risks because they do not undergo FDA premarket review.

Compounded semaglutide products can vary significantly from approved products in packaging, concentration, and administration instructions. Variations include multiple-dose vials, prefilled syringes, and differing concentrations from various compounders.

Reports to the FDA highlighted errors with compounded semaglutide in multiple-dose vials, resulting in patients drawing up more than the prescribed dose. These instances often involved patients administering five to 20 times the intended dose, primarily due to unfamiliarity with syringe measurements.

FDA-approved semaglutide products, available in prefilled pens with standard concentrations, avoid these issues.

However, compounded versions with various concentrations have led to healthcare providers miscalculating doses, sometimes by significant margins.

Price Action: NVO stock is up 0.43% at $128.59 at last check Tuesday.

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