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Kybella® (Allergan) is approved by the FDA for the treatment of excessive submental fat. Demand for the product is expected to continue to rise in the future. During the recent Cosmetic Surgery Forum, both Dr. Jegasothy and Dr. Maas advised against the widespread use of Kybella off-label. Dr. Jegasothy believes that off-label use of Kybella should be limited to experts who have had significant experience with Kybella and its precursor drugs LipoDissolve and/or Lipostabil in the European market over the past 15 years.

But the two experts did not agree about whether or how certain clinicians could use Kybella for off-label purposes. Potential for the new drug to be very significant. Dr. Jegasothy says that I think that the areas which have been most effectively treated by ice or laser fat reduction procedures, such as CoolSculpting, Vanquish and Ultra Shape, are good areas for Kybella to go into to widen its use.

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Dr. Jegasothy has seen positive results from using Kybella in these areas. Kybella was approved in August 2015, according to the FDA. I have also been using Kybella on other parts of my body than the neck, for very limited and very carefully selected patients. Dr. Jegasothy also pays close attention to certain areas that carry blood vessels and try to avoid those areas. I usually inject the love handles, the saddlebags, the area around the waist, and occasionally the fat that is superficially located on the anterior part of the abdomen. I am able to treat patients who are within 10 to 15 percent of their ideal weight. I do not have any results with patients who are heavier than that. They are less satisfied with my treatment results.

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Dr. Maas says that the most dangerous risk of using Kybella off label is that someone can sue you if someone has an adverse event. Kybella warns doctors against using the drug for purposes that go beyond the approved indication. Since the PP specifically states do not use in any area other than the neck, it could cause a liability claim to be denied by your insurance company. Before using a drug that is not recommended, the physician should check with their medical malpractice insurance company.

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This is different from when people use Botox or fillers, where there is no reference to something that is not recommended for the patient's condition, he says. Those physicians who want to use a drug that is not recommended to treat a particular condition should simply submit a short IND to FDA and tell their liability insurance company that they are using a drug that is not recommended to treat that condition.

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Dr. Jegasothy doesn't see any obstacle to the FDA's recommendation to avoid using Kybella outside the neck area. There are some people at the FDA who think that even though Kybella's monograph is more restrictive than most other neuromodulator/filler monographs, doctors may still decide to use it off label if it is appropriate. I believe the FDA does not consider this to be a different type of off-label use than a neuromodulator, but it is certainly not restricted to that.

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My doctor's insurance company is currently willing to allow me to demonstrate off-label use of Kybella in approved courses and conferences. However, that does not cover non-medical personnel who are considering trying to use this treatment. But will not cover non-aesthetists who try to perform the surgery. It is unclear if most malpractice insurers will cover the off-label use of Kybella, unless Allergan broadens the indications on the pack insert for Kybella. Doctors Company believes, like I do, that it is up to opinion leaders like us to generate the data which will spur Allergan to pursue uses for Kybella that are not listed in its current IND (not recommended) and hopefully obtain FDA approval for these uses too.