"Double-Chin" Drug Approved By FDA

The US Food and Drug Administration (FDA) gave its nod to a drug that can help clear double chin or the fat under below the chin, known as submental fat.

While approving the drug Kybella, FDA noted that it had showed efficacy in two clinical trials which enrolled 1,022 adults with moderate or severe submental fat. Kybella is a cell-killer, similar to the naturally occurring substance called deoxycholic acid. It works when injected into fatty area by destroying cell membrane. FDA has approved its use only for fat removal under the chin. Up to 50 injections can be administered during a treatment session. A maximum of six treatments can be administered with at least a month apart.

"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. It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area," said Amy G. Egan, an FDA official.

Some of the side effects that FDA warned include destruction of other tissue like skin, swallowing difficulties and loss of nerve function in facial muscles. Less serious side effects include sensation of burning and redness at the site of injection.

California-based Kythera Biopharmaceuticals manufactures Kybella, FDA informed.