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Submental injectable approved. Read more and see photos.
On April 29, the FDA approved deoxycholic acid (Kybella, Kythera Biopharmaceuticals) for the treatment of moderate-to-severe submental fat in adults. Kybella is the first and only FDA-approved submental contouring injectable drug, according to a Kythera release. The drug received unanimous advisory committee support earlier this year.
Helen M. Torok, M.D., medical director, Trillium Creek Dermatology and Surgery, Medina, Ohio, gives Kybella a thumbs up.
“For those patients who are weary of surgical procedures, this is truly a nonsurgical neck contouring and lifting procedure. The results are permanent as the drug is cytotoxic to the fat cells,” Dr. Torok tells Dermatology Times.
The drug, which destroys the cell membrane when injected into tissue, is not approved or recommended for use outside the submental area.
“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,” according to the FDA’s release.
Dermatologists can use up to 50 injections in a treatment and up to six single treatments given a month apart. Kybella’s single patient use vials should not be diluted or mixed with other compounds.
The FDA’s approval is based on two clinical trials with more than 1,000 adults with moderate or severe submental fat. Subjects received either Kybella or a placebo for up to six treatments. The studies found adults receiving Kybella were more likely to have reduced submental fat than were adults receiving placebo.
Common side effects associated with Kybella include swelling, bruising, pain, numbness, redness and hard areas where patients have been treated. Dermatologists should note that Kybella can cause serious side effects. One such side effect is nerve injury in the jaw, which can result in trouble swallowing, facial weakness or an uneven smile. More than 81% of the adverse reactions reported were mild; 17.4% were mild and 1.6% were severe, according to Kythera.
“The expected side effects of swelling, redness and pain are the result of the drug having its expected effect on the cells and this resolves over a period of several weeks,” Dr. Torok says. “When done properly, there should be no nerve injury or scarring, and the results should be very predictable and gratifying.”
Dermatologists should use caution in patients who have had prior surgical or aesthetic treatment of the submental area. And if there is no distinctive hologram on the vial label, dermatologists are urged not to use the product.
“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,” says Amy G. Egan, M.D., M.P.H., a deputy director in the FDA’s Center for Drug Evaluation and Research.