Pregnancy Warnings

Is Deoxycholic Acid (Kybella) Safe In Pregnancy?

A double chin, also known as submental fat, is a common condition that occurs when a layer of fat forms below your chin. A double chin is often associated with weight gain, but you don’t have to be overweight to have one. Genetics or looser skin resulting from aging may also cause a double chin.

Although there is scarcity of data on submental fat gain in women during pregnancy, most women generally gain somewhere between 25 and 35 pounds (11.5 to 16 kilograms) during pregnancy. Most will gain 2 to 4 pounds (1 to 2 kilograms) during the first trimester, and then 1 pound (0.5 kilogram) a week for the rest of the pregnancy.

What is Kybella?

Kybella by Kythera Biopharma is the first approved pharmacological agent available for submental fat reduction, allowing for a safer and less invasive alternative than surgical procedures.

Kybella is a manmade brand of deoxycholic acid, also known as cholanoic acid. Deoxycholic acid is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria. The two primary bile acids secreted by the liver are cholic acid and chenodeoxycholic acid.

Kybella injection is used to improve the appearance and profile of moderate to severe submental fat (‘double chin’; fatty tissue located under the chin). Deoxycholic acid injection is in a class of medications called cytolytic medications. It works by breaking down cells in fatty tissue.

How does Kybella work?

Kybella is a bile acid which emulsifies and solubilizes dietary fats in the intestine, and when injected subcutaneously, it disrupts cell membranes in adipocytes and destroys fat cells in the tissue where it is injected into the body.  This helps to decrease the appearance of fat that hangs below the chin, sometimes called a double-chin. Kybella has not been tested for safe use on other areas of the body.

Is Deoxycholic acid (Kybella ) Safe In pregnancy?

There are no adequate and well-controlled studies of KYBELLA® (deoxycholic acid) injection in pregnant women to inform the drug-associated risk. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk of major birth defects in the U.S. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. In animal reproduction studies, no fetal harm was observed with the subcutaneous administration of deoxycholic acid to rats during organogenesis at doses up to 5 times the maximum recommended human dose (MRHD) of 100 mg.

Kybella should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby. It is not known if Kybella crosses into human milk.  Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Kybella.

What are the side effects of Kybella?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

•          trouble swallowing;

•          weak muscles in your face;

•          a crooked smile;

•          open skin sores or drainage around treated areas; or

•          pain, burning, irritation, or skin changes where the injection was given.

Common side effects may include:

•          numbness or hardening of treated areas;

•          hair loss around treated areas; or

•          pain, swelling, redness, or bruising, of treated areas.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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