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FDA warns consumers about risks of unapproved versions of weight loss drugs

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DENVER — The Federal Drug Administration (FDA) is warning consumers about unapproved semaglutide, a popular weight loss drug associated with the brand names Ozempic and Wegovy.

Over the past few months, the FDA has received reports of weight loss drug shortages, prompting consumers to search for alternatives.

“None of these drugs are old enough yet to be generic. They're still all brand name because they're protected on that for a certain number of years,“ said Michael Horne, assistant professor for the University of Colorado College of Nursing.

Horne said a monthly dose of semaglutide can cost around $1,000, also leading some consumers to search for more affordable versions.

“So as a result of both the pricing and the shortages, there have been alternatives out there, either things claiming to be a generic version, which they can't. There is no generic version of semaglutide. Or they look for a compounded version,” Horne said. “A potential problem with that is it's not as controlled. So compounded medicines are not FDA-approved. They don't have the same FDA regulation. It doesn't necessarily mean they're bad, but they're not FDA approved, so you don't have the same controls in place.”

A compounded drug is a medicine pharmacies make from scratch.

The FDA has received 364 reports of adverse events with compounded semaglutides and suggests that consumers only purchase the drug from state-approved pharmacies.

“If you're using compounding, you want to use, obviously, a medical provider to prescribe it, because there are a few things, not many, fortunately, it’s a safe drug, but there are a few side effects, primarily GI (gastrointestinal) related,” Horne said.

Horne said some production facilities that make them are not overseen by the FDA, which makes them more risky.

The FDA thinks the number of adverse reactions to compounded semaglutide is higher, but it does not track non-state-approved pharmacies. Consumers can report adverse reactions on MedWatch,the FDA safety information and adverse event reporting program.


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