WASHINGTON (AP) – The Food and Drug Administration is cracking down on what are billed as fat-melting injections used in spas across the U.S., saying the drugs have not been proven safe or effective.
Lipodissolve injections, a popular nonsurgical alternative to liposuction, are used to dissolve small fat deposits around the legs, arms and belly. The FDA said the drugs have not been cleared by federal scientists, as required by law.
The agency issued warning letters to a half-dozen spas that offer the injections, citing them for making unsubstantiated claims about lipodissolve therapy.
“The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” states a letter to All About You Medspa in Madison, Ind.
Other spas cited by the FDA included: Pure Med Spa of Boca Raton, Fla., Monarch Med Spa of King of Prussia, Pa., and three others.
The Web site for Monarch Med Spa claims that, “Rather than go through the pain and discomfort associated with liposuction, patients now have the option of a series of injections with very minimal discomfort.”
Calls to Monarch Med Spa were not immediately returned Wednesday.
FDA regulators called on the spas to stop using such claims and notify the agency within 15 working days of steps they are taking to correct the violations.
“FDA is not aware of any credible scientific evidence to support these claims,” said Kathleen Anderson, an FDA deputy director, on a call with reporters.
Spas that offer the injections say they are safe and effective. But public safety advocates have called for proof and urge patients to think twice before paying thousands of dollars for an unproven procedure.
FDA said it has received reports of permanent scarring and hard lumps on patients’ skin, as well as skin deformations after receiving the therapy.
The FDA also issued a warning to a Brazilian company that sells lipodissolve treatments on two Web sites: zipmed.net and mesoone.com.
Lipodissolve and similar treatments use two chemicals, phosphatidylcholine, or PC, and sodium dioxycholate, or DC. Those chemicals occur naturally in the human body, but that doesn’t necessarily make them safe, said Lenox Hill Hospital plastic surgeon Dr. Jennifer Walden.
“They are used in the metabolic process of our bodies to break down fat, but they were never intended to be extracted, mixed with other ingredients and reinjected to break down fat,” said Walden.
Phosphatidylcholine is found in the FDA-approved drug Infasurf, which is used to treat respiratory problems in premature infants, according to the FDA.
According to Walden, lipodissolve injections are often performed by beauty care specialists who have little or no medical training.
Lipodissolve formulations are usually mixed at medical spas through a process called compounding, in which a pharmacist combines multiple drugs to create a new formulation, Walden said. The FDA does not regulate the practice of medicine and declined to discuss drug compounding.
“We’re not aware of where these spas are getting their drugs, therefore we cannot comment on the issue of compounding this product,” said FDA pharmacist Samia Nasr.
The FDA urged physicians who are using the drugs cosmetically to submit an approval application for regulatory review.
Date: April 8, 2010
Source: Associated Press