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FDA warns about complications of unapproved fat-dissolving injections.

Posted 14 Jan 2024

The U.S. Food and Drug Administration (FDA) has received reports of adverse reactions to fat-dissolving injections that are not FDA-approved. The reactions have included permanent scars, serious infections, skin deformities, cysts, and deep, painful muscle knots. In addition, improper or unsafe injection practices by unlicensed personnel can increase the risk of scarring and skin infections. The safe and effective uses of these products depend on the correct number and location of injections, proper needle placement, and proper administration technique. Some consumers received the injections at clinics or medical spas by personnel who might not have been properly licensed to give the injections.

Some consumers who reported complications purchased the drugs online and injected it themselves. Consumers should not purchase ingredients for unapproved fat-dissolving injections or inject the drugs themselves.

Unapproved fat-dissolving injections are being marketed online under brand names such as Aqualyx, Lipodissolve, Lipo Lab, Kabelline, and others. The FDA has not evaluated their safety or effectiveness. Sellers have claimed their products reduce fat deposits in areas of the body such as the chin, back, thighs, upper arms, and stomach. Common ingredients in these injections include phosphatidylcholine (PPC) and sodium deoxycholate (DC). These ingredients have been used alone or together, sometimes referred to as “PCDC injections.”

A prescription drug called Kybella, the brand name for deoxycholic acid, is the only fat-dissolving injectable drug that is FDA-approved. Its only approved use is to reduce the amount of fat under the chin (“double chin”) in adults. The approved label for Kybella notes injections should be administered by a health-care professional only.

Using fat-dissolving injections that are not FDA-approved can be harmful. FDA, Dec 20, 2023 https://www.fda.gov/drugs/buying-using-medicine-safely/using-fat-dissolving-injections-are-not-fda-approved-can-be-harmful

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