FDA reports adverse effects of off-brand Ozempic amid ‘shortage’

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FDA reports adverse effects of off-brand Ozempic amid ‘shortage’
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The Food and Drug Administration is warning consumers not to use off-brand weight loss drugs containing semaglutide, the active ingredient in Ozempic and Wegovy.

Semaglutide, meant for patients with type 2 diabetes, is a glucagon-like peptide-1 receptor agonist, meaning that it mimics the GLP-1 hormone released in the GI tract to signal fullness, helping people shed excess weight.

“Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA wrote.“Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective,” the agency added.

Compounded drugs are not FDA-approved, officials said, which means they have not been vetted for safety in humans.“Patients should not use a compounded drug if an approved drug is available to treat a patient,” the FDA wrote. “Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.”

But if there is a shortage of a particular drug, a compounded version could be produced if it meets certain FDA requirements.“Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA,” officials said.

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