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The U.S. Food and Drug Administration (FDA) warned about the safety risks of using compounded or custom-made versions of popular weight-loss drugs such as Wegovy and diabetes drug Ozempic.
The health regulator on Wednesday said it had received reports of adverse events after patients used compounded versions of semaglutide, the active ingredient in Danish drugmaker Novo Nordisk’s Wegovy and Ozempic.
The FDA warned patients to refrain from using a compounded drug if an approved drug is available.
Compounded drugs are created by combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.
The agency said it does not review compounded versions of these drugs for safety, effectiveness, or quality, adding, it had received reports that compounders might be using salt forms of semaglutide, which are different active ingredients than those used in the approved drugs.
Novo Nordisk’s Ozempic, approved to lower blood sugar levels in adults with type 2 diabetes, saw a supply shortage earlier this year due to high demand, partly driven by prescriptions to non-diabetic patients seeking to lose weight.
The U.S. is expected to account for as much as 90% of weight-loss drug sales due to the number of potential patients and higher pricing than other countries, industry analysts and executives say.