FDA Warns of Unapproved Fat-Dissolving Injections

Derick Alison
Derick Alison
3 Min Read

The FDA is warning against unapproved fat-dissolving injections after users have reported painful knots, permanent scars, and serious infections.

Users have reported such adverse reactions after receiving the injections at clinics or med spas — or after purchasing the products online and injecting themselves, the agency announced.

Injections are being marketed and sold online under brand names like Aqualyx, Lipodissolve, Lipo Lab, and Kabelline, among others. Sellers claim the products reduce fat deposits in multiple areas of the body, including the chin, back, thighs, upper arms, and stomach, according to the agency.

Common ingredients in the products include phosphatidylcholine (PPC) and sodium deoxycholate (DC), and when used together, the products are sometimes referred to as “PCDC injections.”

“These ingredients pose a significant safety risk because they are unapproved, which means the FDA has not evaluated their safety or effectiveness,” FDA stated.

In its warning, the FDA included images of “multiple infected knots at the injection sites” on the upper arms of a woman after receiving unapproved fat-dissolving injections. Following 2 months of antibiotic treatment, the appearance of the knots remained pronounced.

Beyond warning against the products themselves, the FDA also noted potential harms associated with improper or unsafe practices by unlicensed personnel who might be providing fat-dissolving injections, which could increase the risk for scarring and skin infections, and could result in serious complications. Safety and effectiveness depend on the correct number and location of injections, the agency added, as well as proper needle placement and administration technique.

Ultimately, the prescription drug deoxycholic acid (Kybella) is the only fat-dissolving injectable drug the FDA has approved, the agency stated. Its indication is narrow: to reduce the amount of fat under the chin, or “double chin,” in adults. It is not approved for use in any other areas of the body. Additionally, injections should only be administered by a healthcare professional, the agency said.

FDA warned that people should not purchase fat-dissolving products from websites to inject themselves. Furthermore, individuals should tell their healthcare provider if they received fat-dissolving injections and are experiencing side effects.

The agency also advised individuals to report any adverse reactions after receiving fat-dissolving injections to its MedWatch program.

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    Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.

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