FDA issues warning about dosing errors associated with popular weight-loss drugs

The Food and Drug Administration has issued a warning to patients and healthcare providers about overdoses associated with a drug used for weight loss.

FDA officials said the agency has received reports of dosing errors associated with compounded semaglutide injectable products, resulting in patients seeking medical attention or requiring hospitalization after receiving between five and 20 times the intended dose.

These errors are the result of patients mistakenly self-administering incorrect doses of the drug and healthcare providers miscalculating doses, according to the FDA.

“Many of the patients who received vials of compounded semaglutide lacked experience with self-injections, according to adverse event reports,” FDA officials said in a statement Friday. “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.”

There are currently three FDA-approved semaglutide products: Ozempic , Wegovy, and Rybelsus.

Compounded versions of the drug pose a higher risk to patients because they are not reviewed by the FDA for safety, quality and effectiveness, according to the agency. Product concentrations may vary depending on the compounder, and the instructions accompanying the drug may direct users to administer injections in “units” rather than milligrams or milliliters.

FDA officials said patients should speak with their healthcare providers about how to administer the correct dose and that healthcare providers and compounders should “provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe.”

CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER

The agency is also encouraging compounders, healthcare providers, and patients to report overdose symptoms and medication errors associated with compounded semaglutide.

Overdose symptoms include nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis, and gallstones.