FDA Issues Warning Regarding 'Lipodissolve' Procedures
Agency says the products have not been proven to be safe or effective
WEDNESDAY, April 7 (HealthDay News) -- The U.S. Food and Drug Administration has issued warning letters to six U.S.-based medical spas and a Brazilian company, saying they made false or misleading statements that "lipodissolve" procedures are safe and effective, or otherwise misbranded the products.
Lipodissolve involves drug injections intended to dissolve and remove small pockets of fat. The U.S. companies that received the warning letters have made claims that the drugs they use for lipodissolve procedures are effective and safe. However, the FDA has not evaluated or approved the products for this use.
The drugs most often used for lipodissolve procedures are combinations of phosphatidylcholine and deoxycholate, but sometimes ingredients such as vitamins, minerals and herbal extracts are included in lipodissolve mixtures, according to the FDA. The agency said it is not aware of any credible scientific evidence that supports the effectiveness or safety of lipodissolve for fat elimination.
"We are concerned that these companies are misleading consumers," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by the FDA for fat removal."