FDA Issues Warning Regarding 'Lipodissolve' Procedures

Agency says the products have not been proven to be safe or effective
By Beth Gilbert
HealthDay Reporter

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."

More Information

Copyright © 2010 HealthDay. All rights reserved.

Powered by

jQuery UI Accordion - Default functionality

For life-long learning and continuing professional development, come to Lippincott's NursingCenter.

Nursing Jobs Plus
Featured Jobs
Recommended CE Articles

Blunt Chest Trauma
Journal of Trauma Nursing, November/December 2014
Expires: 12/31/2016 CE:2 $21.95

The School Age Child with Congenital Heart Disease
MCN, The American Journal of Maternal/Child Nursing, January/February 2015
Expires: 2/28/2017 CE:2.5 $24.95

Understanding multiple myeloma
Nursing Made Incredibly Easy!, January/February 2015
Expires: 2/28/2017 CE:2 $21.95

More CE Articles

Subscribe to Recommended CE

Recommended Nursing Articles

Comprehensive Care: Looking Beyond the Presenting Problem
Journal of Christian Nursing, January/March 2015
Free access will expire on March 2, 2015.

Pain and Alzheimer dementia: A largely unrecognized problem
Nursing Made Incredibly Easy!, January/February 2015
Free access will expire on February 16, 2015.

Glycemic control in hospitalized patients
Nursing2015 Critical Care, January 2015
Free access will expire on February 16, 2015.

More Recommended Articles

Subscribe to Recommended Articles

Evidence Based Practice Skin Care Network NursingCenter Quick Links What’s Trending Events