FDA Issues Warning on Unapproved Semaglutide Amid Drug Shortages
DENVER — The Federal Drug Administration (FDA) has issued a warning to consumers about the risks associated with unapproved versions of semaglutide, the active ingredient in the popular weight loss medications Ozempic and Wegovy. Recent reports indicate a surge in shortages of these drugs, prompting many consumers to seek alternatives.
According to Michael Horne, an assistant professor at the University of Colorado College of Nursing, semaglutide’s high cost—often around $1,000 per month—combined with availability issues, has led individuals to search for more affordable options. Unfortunately, no generic versions exist as the drugs are still under brand name protection.
Horne highlighted the dangers of considering compounded semaglutide, which pharmacies create by mixing ingredients to produce the drug. Unlike standard medications, compounded options are not FDA-approved and come with increased risks. The FDA has received 364 reports of adverse reactions related to compounded semaglutide, emphasizing the importance of purchasing drugs from state-approved pharmacies to mitigate these risks.
While semaglutide is generally considered safe, Horne noted that side effects can occur, particularly gastrointestinal issues. He recommends that consumers consult a medical provider before considering compounded alternatives, as oversight can vary among production facilities.
The FDA advises consumers to report any adverse reactions through MedWatch, the agency’s safety information and adverse event reporting program. As awareness of these issues spreads, health officials encourage adherence to FDA guidelines to ensure patient safety in the face of a challenging drug landscape.
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