HEALTH
FDA Warns Of Serious Side Effects From ‘Fat-Dissolving’ Injections Not Approved By The Agency
FDA
The U.S. Food and Drug Administration is sounding the alarm after receiving reports of bad side effects to so-called fat-dissolving injections not approved by the agency.
Makers of injection lipolysis treatments marketed or sold under brand names including Aqualyx, Lipodissolve, Lipo Lab, Kabelline, and others claim the injections can reduce fat deposits in the chin, back, thighs, upper arms, stomach and other areas. They are also sometimes called PCDC injections after their main ingredients, phosphatidylcholine (PPC) and sodium deoxycholate (DC).
But the FDA says it has received reports from users of these unapproved treatments of adverse reactions including permanent scars, serious infections, skin deformities, cysts, and deep, painful knots.
In addition to the injections not being approved by the FDA, meaning the agency has not evaluated their safety or effectiveness, there are also risks associated with improper injection technique.
Some consumers received the treatments at spas or clinics where staff may not be properly licensed to administer such injections, the FDA said. Other consumers purchased the products online and administered the injections themselves.
The FDA said the only fat-dissolving injectable drug approved by the agency is the prescription drug Kybella, which is only approved for reducing fat under the chin, or double chin, and not any other areas of the body. Kybella injections are only to be administered by a healthcare professional.
The agency is advising consumers not to purchase unapproved fat-dissolving injections, or attempt to inject them. The FDA is also urging anyone seeking medical care for an adverse reaction to report their reactions to the agency’s MedWatch program.
TMX contributed to this article.
