FDA Warns of Overdose Risk with Imitation Weight Loss Drugs

The Food and Drug Administration has issued a warning regarding hospitlizations related to overdoses from injectible weight-loss drugs. Last Friday, the FDA said to healthcare providers and patients, that some invididuals required medical attention or hospitalization after taking incorrect doses of compounded semaglutide products.

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Compounded pharmacuticals are copies of approved medications that the FDA allows during a shortage, but these copies do not undergo the same process. According to Business Insider , this applies to semaglutide, promoted under the brand names Ozempic and Wegovy. The agency emphasized that compounded drugs poses a high risk to patients in comparison to FDA-approved drugs.

“Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to the adverse event reports. Unfamiliarity with withdrawing medication from a vial into a syringe and coupled with confusion between different units of measurement (e.g., milliliters, milligrams and “units”) may have contributed to dosing errors,” t he agency wrote on its website.

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“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 didn’t disclose the number of reports it received but noted that patients have adminsitered 5 to 20 times the intended dose, and one healthcare provider prescribed at least three patients 20 unites instead of two. The FDA highlighted that there are no industry standards for compounded semaglutide, leading to variations in concentrations, containers, syringe sizes, and instructions, leading patients to experience various symptoms.

“Some patients sought medical attention or required hospitalization after the medication error. Reported semaglutide overdose adverse events include gastrointestinal effects (e.g., nausea, vomiting, abdominal pain), fainting, headache, migraine, dehydration, acute pancreatitis and gallstones.”

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