New Off-label use of botox: treating depression

Botox injections are currently FDA approved for treatment of overactive bladder, chronic migraine headaches, repetitive neck spasms, spastic arm muscles, overactive sweat glands in the armpits and two eye conditions: painful contraction of the muscles surrounding the eye and misaligned eyes (strabismus).

Most things have to do with the muscles (because botox works on the muscles), with the exception of overactive sweat glands and maybe migraines.

But when Botox was approved by the FDA for chronic migraine treatment in 2010, there has been an avalanche of off-label uses. Maybe because the issues being addressed don’t seem to have anything to do with the muscles. Treatment for depression is one of the diseases that are being tested for off-label use.

Dr. Eric Finzi is a cosmetic dermatologist in Maryland and treats 1-2 depressed patients daily with botox injections between the eyebrows. He believes that the muscle that sits in the forehead (the corrugator muscle) is connected to the emotions that are in the brain. He thinks there is a feedback loop that he calls “emotional propioception” between the amygdala region deep in the brain (which is involved in emotions, for example) and the blocked muscle. When people are depressed, their corrugator muscle is activated. When the muscle is activated, the amygdala is “noise”, says Finzi, who in 2014 published a study that showed significant improvement in depressive symptoms in 52% of injected subjects compared to 15% injected with placebo.

MBut there are several things in this:

First, the use of botox to treat depression remains an off-label use. Using an off-label drug means using it for purposes other than what the FDA approved it for. This means that safety and efficacy is not fully established by the FDA. Note that 1 to 5 prescriptions written in the United States are off-label, and several studies suggest that 50-75% of these off-label uses have little or no evidence of efficacy. Allergan (the botox manufacturer) is currently in Phase 2 collecting preliminary data on the effectiveness of botox in the treatment of depression. To date, many of the studies on botox for the treatment of depression have been small and limited to short follow-up periods.

Second, with regard to Dr. Eric Finzi: If you google his name or “botox and depression” you will find this page: Botox For The NBC video (embedded on the website) seems to be more advertising with terms such as “groundbreaking” and “breakthrough”. There is also the testimony of two patients: one who says: “with botox there was a real positive side effect that my skin looks smoother and which woman would not?” But what does depression really have to do with it? It is possible for botox recipients to simply feel better because they like the way they look.

On the other hand, you don’t see anywhere on the website or in the embedded videos that Finzi’s 2014 studio was funded by the Chevy Chase Cosmetic Center, where Dr. Finzi is the medical director and chairman. Nor does it mention that Finzi has received a US patent for the treatment of botox depression. When asked to tell more about it, he replied: “I have no freedom to discuss it”. He admits he was a paid consultant for Allergan in the past, but “it’s over a few years ago now”.

The text is a summary / translation from this article, which was published in 2017. (The article contains a video with an interview):