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FDA Approves Kybella for Reducing Submental Fat

Use for fat outside submental area not approved, not recommended

WEDNESDAY, April 29, 2015 (HealthDay News) -- Kybella (deoxycholic acid) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe submental fat.

Kybella is identical to deoxycholic acid that is produced in the body, the FDA said Wednesday in a news release. When injected into tissue, Kybella works as a cytolytic agent and physically destroys cell membranes. 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. 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 on the vial label, the agency said, noting that packages that don't include the hologram must not be used.

Kybella is produced by Kythera Biopharmaceuticals, based in Westlake Village, Calif.

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