- posted by @plsurgeon
(www.plsurgeon.com)
FDA issues warnings about fat-melting injections used in spas across the US.
The AP (4/8, Perrone) reports that "the Food and Drug Administration is cracking down on what are billed as fat-melting injections used in spas across the US, saying the drugs" have not "been cleared by federal scientists, as required by law." The agency asked a Brazilian company and six medical spas in the US to provide a written response within 15 days with their action plan to correct the situation, the Wall Street Journal (4/8, Stynes) reports.
The Philadelphia Inquirer (4/8, Burling) explains, "In a procedure known variously as lipodissolve, mesotherapy, lipozap, lipotherapy, or injection lipolysis, patients receive a series of injections meant to 'dissolve and permanently remove small pockets of fat from various parts of the body,' the FDA said. The primary ingredients are phosphatidylcholine and deoxycholate, although vitamins and herbs may also be added." The agency "has not evaluated the drugs and says it knows of no 'credible scientific evidence' that shows they eliminate fat."
No "definitive studies of side effects" have been reported, and the risks of the injections "also aren't understood," the NPR (4/7, Popovich) "Shots" blog reported. However, some patients have experienced "pain at the injection site, knots under the skin, and permanent scarring."
Nevertheless, the CNN (4/7, Willingham) "Paging Dr. Gupta" blog reported that "the companies have been cited for a variety of regulatory violations, including making unsupported claims that the products have an outstanding safety record and are superior to other fat loss procedures, including liposuction."
According to HealthDay (4/7, Reinberg), "some of these companies have claimed that lipodissolve can treat certain medical conditions, such as male breast enlargement, benign fatty growths called lipomas, excess fat deposits, and surgical deformities."
WebMD (4/7, Mann) reported that the six companies receiving warnings in the US include Monarch Medspa in King of Prussia, PA; Spa 35 in Boise, ID; Medical Cosmetic Enhancements in Chevy Chase, MD; Innovative Directions in Health in Edina, MN, PURE Med Spa in Boca Raton, FL, and All About You Med Spa in Madison, IN. In addition, the agency "admonished a Brazilian company for hawking lipodissolve products on two websites: zipmed.net and mesoone.com." The FDA has also "issued an import alert to prevent the importation and distribution of unapproved lipodissolve drug products into the United States."
MedPage Today (4/7, Smith) reported that Kathleen Anderson, PharmD, of the FDA's Center for Drug Evaluation and Research, explained that if the companies' response to the FDA's letter is unsatisfactory, "they could face injunctions, seizure of the products, and civil or criminal action." The Idaho Statesman (4/8, Sewell), CQ HealthBeat (4/8, Reichard), and Reuters (4/8) also cover the story.
