Medication Monitor

Generic Name (Trade Name—Company)
April 30, 2015

Deoxycholic acid

(Kybella—Kythera Biopharmaceuticals)
Treatment approved for fat below the chin

FDA has approved deoxycholic acid, a treatment for adults with moderate-to-severe fat below the chin, known as submental fat.

The drug product is identical to the deoxycholic acid produced in the body that helps absorb fats. It is a cytolytic drug that physically destroys the cell membrane when injected into tissue. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.

Deoxycholic acid injections must be administered by a licensed health professional. Patients may receive up to 50 injections in a single treatment, with up to 6 single treatments administered no less than 1 month apart. It is being provided in single patient use vials and should not be diluted or mixed with any other compounds.

Safety and effectiveness of deoxycholic acid for treatment of submental fat were established in two clinical trials that enrolled 1,022 adult participants with moderate or severe submental fat. Participants were randomly assigned to receive deoxycholic acid or a placebo for up to six treatments.

The results showed that reductions in submental fat were observed more frequently in participants who received deoxycholic acid versus placebo.

Deoxycholic acid can cause serious adverse effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing.

The most common adverse effects include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.

Deoxycholic acid should not be used outside of the submental area or 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.

The agent is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, the product should not be used.