The FDA is warning healthcare providers of dosing errors associated with compounded versions of semaglutide, the active ingredient in Ozempic, Rybelsus and Wegovy.
The agency has received reports of hospitalizations and adverse events tied to the issue, including gastrointestinal issues, fainting, headache, dehydration and acute pancreatitis, according to a July 26 update.
Most adverse events occurred when patients self-administered incorrect doses of weight loss drugs from multiple-dose vials, sometimes taking five to 20 times the intended amount. Several reports also involved clinicians miscalculating doses, resulting in patients receiving five to 10 times more than the intended dose.
The agency said patients' inexperience with self-injections and confusion over different measurement units may have contributed to the errors.
"FDA encourages health care providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe," the agency said in the update. "Additionally, health care providers should be vigilant when prescribing and administering compounded semaglutide, as there may be different concentrations available."
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