Some compounding pharmacies are using unauthorized active ingredients to make copycat versions of Ozempic and Wegovy.
Some compounding pharmacies are making copycat versions of the diabetes drug Ozempic and the weight-loss drug Wegovy, and people are reporting unwanted side effects from these unauthorized medications, the Food and Drug Administration warned this week.
The active ingredient in both Ozempic and Wegovy is semaglutide, which mimics a hormone that's naturally released in the gastrointestinal tract after a person eats. This hormone — glucagon-like peptide-1 — triggers insulin release, which lowers blood sugar levels by helping usher sugar into cells. Semaglutide also slows the rate at which the stomach empties after a person eats, and it interacts with parts of the brain that help users feel full for longer.
So why are pharmacies making unauthorized versions of Ozempic and Wegovy? Both medications are currently listed on the FDA's drug shortages list, and again, when drugs are in shortage, compounding pharmacies are sometimes permitted to make their own versions by combining ingredients, provided they meet certain federal requirements. However, compounded drugs are not FDA-approved, and the FDA does not verify their safety and effectiveness as it does for normal drugs.
The salt forms of semaglutide likely behave differently in the body and have not been shown to be safe and effective, the FDA stated. The agency is"not aware of any basis for compounding using the salt forms" that would meet the federal requirements for making compounded drugs.
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