The FDA approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.
Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic, cell destructive, drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells. However, the drug can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects of Kybella include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.
“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment,” said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”
Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds.
Kybella should not be used outside of the submental area, and it should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.
See the FDA Announcement
See also Medical Law Perspectives, September 2012 Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results