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FDA Approves Treatment for Dissolving Chin Fat

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Behavioral & Mental Health
Laboratory Procedures
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Contributed byKrish Tangella MD, MBAMay 01, 2015

On April 29, 2015, the Federal Food and Drug Administration (FDA) announced that it approved a drug called Deoxycholic acid. This drug was approved for use in adults with moderate to severe fat under their chins called submental fat. This condition is otherwise known as having a double chin.

According to a Harvard School of Public Health publication, less than 15% of adults were obese in the year 1990, compared to 69% of adults who are overweight or obese today. Apart from the plethora of problems associated with obesity, there also comes an issue of self-esteem and self-worth. In fact, in a survey conducted by the American Society for Dermatologic Surgery, 52% of the respondents were considering cosmetic surgery. Of these respondents, 68% said that the fat under their chins troubled them.

To address the issue of double chins, research was being carried out globally. A substance called Deoxycholic acid, also known as the secondary bile acid, is naturally produced in the intestine. In the human body, the role of Deoxycholic acid is to emulsify the fat for intestinal absorption. Sodium deoxycholate, the sodium salt of the acid, is routinely used in laboratory procedures to lyse cells, or to break down their membrane.

The ability of Deoxycholate to lyse cells was put to use for destroying fat cells. Clinical trials were designed and completed with a form of Deoxycholic acid identical to what is produced naturally in humans. The drug, when injected properly into the fat of the chin, destroys the cell membrane of fat cells.  Care must be taken in the procedure, as it can destroy skin cells if inadvertently injected into those cells.

A patient has to undergo a series of injections. In each session, tiny needles containing the drug are inserted into the fat deposit under the chin. Each session lasts about 20 minutes, according to one Principal Investigator (as reported by The New York Times).

The approval of the drug is for fat under the chin only, says the FDA, adding that it is not known whether the drug is safe or effective for treatment in other areas.

A licensed practitioner must administer the approved drug, which is in the injectable form. The common side effects noticed in trial participants were:

  • Numbness
  • Swelling
  • Bruising
  • Pain
  • Hardness in the treatment area

The drug could also cause some serious side effects. These include:

  • Nerve injury in the jaw causing an uneven smile
  • Facial muscle weakness
  • Trouble swallowing

The FDA cautions against the injection if the site is infected; additionally, if the injection site has had prior cosmetic surgeries performed, caution is advised.

According to the New York Times, the drug manufacturing company has stated that it should be commercially available late summer, 2015.

Written by Mangala Sarkar Ph.D.

Primary Reference:

U.S. Food and Drug Administration. (n.d.). Retrieved May 1, 2015, from http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm444978.htm

Additional References:

An Epidemic of Obesity: U.S. Obesity Trends. (n.d.). Retrieved May 1, 2015, from http://www.hsph.harvard.edu/nutritionsource/an-epidemic-of-obesity/

Obesity Action Coalition » Self Esteem, Insecurity and Obesity. (n.d.). Retrieved May 1, 2015, from http://www.obesityaction.org/educational-resources/resource-articles-2/general-articles/self-esteem-insecurity-and-obesity

ASDS — American Society for Dermatologic Surgery. (n.d.). Retrieved May 1, 2015, from https://www.asds.net/consumersurvey/

Evaluation of the Effect of ATX-101 on QT/QTc Intervals (ATX-101-11-24). (n.d.). Retrieved May 1, 2015, from https://clinicaltrials.gov/ct2/show/NCT01706679?term=deoxycholic acid&rank=1

Rzany, B., Griffiths, T., Walker, P., Lippert, S., McDiarmid, J., & Havlickova, B. (2014). Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: Results from a phase III, randomized, placebo-controlled study. British Journal of Dermatology, 170(2).

Louis, C. (2015, April 30). Injection Offers Option to Slim Down Double Chin Without Surgery. Retrieved May 1, 2015, from http://www.nytimes.com/2015/05/01/health/injection-kybella-double-chin.html?_r=0

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