The Food and Drug Administration has issued a warning about compounded versions of popular weight loss drugs over concerns that errors in administering the medications could lead to overdoses.
In an alert, the FDA said it had been notified of issues with patients measuring and self-administering compounded semaglutide injections with the wrong doses. Many of the patients lack experience with self-injection of the drugs and are unfamiliar with withdrawing medication from a vial into a syringe, the FDA said. Other reports say users are confused over units of measurement like milliliters, milligrams and units.
In some cases, it was the compounding pharmacies that miscalculated drug doses.
“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 alert noted, adding overdoses can result in patients being hospitalized.
Semaglutide overdose symptoms include low blood sugar, nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones, according to the FDA.
There are currently three FDA-approved semaglutide products on the market – Wegovy, Ozempic and Rybelsus – though cost and access have many patients turning to cheaper compounded products. Many of these compounded drugs come from online pharmacies and containers and packaging isn’t uniform and those differences can add to the confusion.
“Compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, quality or effectiveness. Compounded drugs should only be used for patients whose medical needs cannot be met by an available FDA-approved drug,” the agency said in a statement.
Users were advised to talk to their healthcare provider or compounded about how to measure and administer the recommended doses of the drugs.
