People are being maimed by unauthorized fat-dissolving injections meant to tighten up double chins and dissipate flab along the arms, thighs and stomach, the U.S. Food and Drug Administration warns.
The shots are supposed to break down fat cells and reduce fat deposits in the areas around the injection sites.
But adverse reactions from the unapproved injections are causing scarring, skin deformities, cysts, painful knots, and serious infections, the FDA said in an agency news release.
The unapproved injections are being marketed under brand names like Aqualyx, Lipodissolve, Lipo Lab and Kabelline, the FDA said.
Common ingredients in the injections include phosphatidylcholine (PPC) and sodium deoxycholate (DC). These ingredients have been used alone or together, and are sometimes referred to as “PCDC injections.”
The FDA has received reports of consumers harmed by injections they received at clinics or med spas from attendants who might not have been properly licensed to give the shots.
The agency also has heard from some consumers who bought the unapproved shots online and injected the drugs themselves.
The FDA has approved only one injectable drug for dissolving fat, a prescription medication called Kybella, the agency said.
The drug, which is deozycholic acid, is FDA-approved to treat double chins in adults. Deozycholic acid is a bile acid naturally produced by intestinal bacteria to help break down fats during digestion.
The FDA warns that improper or unsafe injection practices can increase the risk of scarring, skin infections and serious complications.
Safe and effective use of a fat-dissolving agent involves calculating the correct number and location of the injections, placing the needles properly, and administering the shots in a safe and sterile manner, the FDA said.
Kybella’s label notes that the shots should be administered only by a health care professional, the agency noted.
People shouldn’t buy fat-dissolving products from websites, much less attempt to inject them, the FDA added.
Instead, they should consult their doctor about FDA-approved treatments like Kybella.
Folks who have received these injections and are experiencing side effects should seek medical care. They also should report their case to the FDA’s MedWatch program, which helps the agency track medication safety issues.
The American Academy of Dermatology has more about noninvasive fat removal.
SOURCE: U.S. Food and Drug Administration, news release, Dec. 20, 2023
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