Generic Ozempic, Wegovy manufacturers with semaglutide might be harmful: FDA

The U.S. Meals and Drug Administration is warning customers to not use off-brand variations of the favored weight-loss medicine Ozempic and Wegovy as a result of they won’t include the identical components because the prescription merchandise and is probably not secure or efficient.

Company officers mentioned this week that they’ve acquired studies of issues after sufferers used variations of semaglutide, the lively ingredient within the brand-name medicines, which have been compounded, or combined in pharmacies. Officers did not say what the issues had been.

The difficulty is that these variations, typically offered on-line, include a model of semaglutide that’s utilized in lab analysis and has not been authorized to be used in folks.

“Compounded medicine will not be FDA-approved, and the company doesn’t confirm the protection or effectiveness of compounded medicine,” the discover mentioned.

‘Quick and vital weight reduction’

Gross sales of semaglutide merchandise have soared previously few years after the drug was proven to spur quick and vital weight reduction. The medicine manufactured by Novo Nordisk embrace manufacturers Ozempic and Rybelsus, used to deal with diabetes, and Wegovy, authorized to deal with weight problems.

Demand for the medicines has outstripped provide. As of Might, Ozempic and Wegovy stay on the FDA’s record of drug shortages. When medicine are in brief provide, compounding pharmacies are permitted to provide variations of these medicines.

Customers ought to solely use medicine containing semaglutide with a prescription from a licensed well being care supplier and obtained from a state-licensed pharmacy or different services registered with the FDA, the company mentioned.

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