WEDNESDAY, April 29, 2015 (HealthDay News) -- Kybella (deoxycholic acid) has been approved by the U.S. Food and Drug Administration to treat excess fat below the chin, a condition best known as "double chin."
Kybella is identical to the body chemical deoxycholic acid, which helps absorb and destroy fats, the FDA said Wednesday in a news release. But the agency warned the drug is not meant to target fats elsewhere in the body, and could destroy healthy cells in the skin and elsewhere if injected improperly.
The drug is approved to be injected into fat tissue in the "submental" area, located just below the chin. Kybella's safety and effectiveness were evaluated in clinical studies involving more than 1,000 people with moderate-to-severe submental fat.
The drug can cause serious side effects, the agency warned, including nerve injury in the jaw, uneven smile, facial muscle weakness and trouble swallowing. More common side effects include swelling, bruising, pain, numbness, redness and localized hard tissue.
Kybella shouldn't be used outside the chin area, or if there's an infection at or near the injection site. It should be given with caution if the user has had prior surgery involving the area, the FDA warned.
To avoid counterfeits, legitimate packages of the drug will contain a unique hologram, the agency said, noting that patients must not use packages that don't include the hologram.
Kybella is produced by Kythera Biopharmaceuticals, based in Westlake Village, Calif.
Visit the FDA to learn more.