The U.S. Food and Drug Administration (FDA) has approved Kybella, a product of Kythera Biopharmaceuticals that is said to be a treatment for double chins in adults.
The FDA explained in its press announcement that Kybella is identical to the deoxycholic acid that is produced in the body and acts as a fat absorber. The newly approved drug is a cytolytic drug, which physically destroys the cell membrane when injected into tissue.
While its main purpose is to dissolve fat, the FDA has made it clear that injecting the drug in other areas of the body other than the submental area or the chin area is not approved or recommended. Patients who have had surgeries or other treatments on this area should be cautious about using the drug, and patients should not use it if there is an infection in the injection spot.
"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.
If not injected by a professional, the drug could cause serious side effects. Nerve injury in the jaw could occur and result to an uneven smile, facial muscle weakness, and difficulty in swallowing. Other negative effects include numbness, bruising, swelling and hardness in the treatment area.
Kythera Biopharmaceuticals, based in Westlake Village, Calif., has yet to reveal the price for the drug, according to the New York Daily news.
