FDA Warns: Weight Loss Drugs Overdose Risk

The Food and Drug Administration (FDA) has issued a significant warning regarding the use of compounded semaglutide, alerting individuals to the potential dangers associated with these products. Overdoses have been increasingly reported, stemming from dosage errors that lead to unpleasant symptoms like nausea, vomiting, abdominal pain, and even fainting, according to a statement released on July 26.

Semaglutide, a medication noted for its effectiveness in weight loss management, has seen a surge in popularity. However, while the FDA has approved products like Ozempic and Wegovy, which are conveniently available as single-dose prefilled pens for weekly injections, the compounded versions are not FDA-approved. These compounded products typically require users to measure and draw the medication from a vial before injecting it, increasing the risk of errors.

The FDA's statement highlighted that these errors often arise from patient measuring mistakes and healthcare providers miscalculating the correct dosages. “Many patients receiving vials of compounded semaglutide have little experience with self-injections,” the agency noted, emphasizing that the unfamiliarity with how to withdraw medication—coupled with confusion over different units of measurement like milliliters, milligrams, and “units”—may lead to dosage blunders.

Semaglutide belongs to a category of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists, which, along with Wegovy and Ozempic, includes an oral tablet known as Rybelus. All of these medications are available only by prescription.

In cases where there is a shortage of FDA-approved medications or if an approved drug fails to meet an individual's medical requirements, healthcare facilities can legally provide compounded drugs tailored to specific needs. Typically, these compounded medications are supplied by medical spas, wellness clinics, and pharmacies.

“Compounded drugs can be invaluable for individuals who may