Only 20 units of Botox are FDA-approved but off-label use is commonly triple or more. Are we the human guinea pigs?

I am considering using Botox on frown lines but my research shows only 20 units are FDA-approved based on clinical studies and there is no published data on off-label amounts so what HARD CLINICAL EVIDENCE is there that doctors can safely double, triple, quadruple injection amounts?? Even wikipedia quotes that as little as 14 units of a mouse lethal dose was detected in the blood of poisoned humans. Info is conflicting and answers vague so how can a doctor feel educated and accurately informed?

Doctor Answers 11

Botox is the most widely researched drug in the world

Botox is the most extensively researched drug in the world. They even use it on babies to treat certain medical condition. If you read the literature, you will find that there is a wealth of research conducted on Botox and its safety. 

Botox over 20 units ? Is this OK

We have been using much larger total quantities of Botox for many years. If a doctor treats more "areas" they will use a higher TOTAL dose. HOwever, one area might not take more then 20-25 units in and of itself. When you read studies they are usually referring to an area treated.. Larger doses are just fine. 

Jo Herzog, MD
Birmingham Dermatologist
5.0 out of 5 stars 18 reviews

Botox

in fact, there is a large amount of what you call "hard clinical evidence" for doses of Botox higher than what is currently FDA approved.  We could have a long conversation about what FDA approval means and why we don't have FDA approval for everything we do with our medications.  The most commonly prescribed drug for acne has never been FDA approved for acne, the most commonly prescribed drug for high blood pressure has never been FDA approved for high blood pressure and the most commonly prescribed antiaging cream [Retin-A] has never been approved for antiaging.  I would suggest you find a board-certified dermatologist or plastic surgeon you have faith in and trust their judgment.  It is our job and our Mission to be "educated and accurately informed."  I hope you find this useful.

Peter J. Jenkin, MD, FAAD, FRCPC
Seattle Dermatologic Surgeon
5.0 out of 5 stars 2 reviews

Only 20 units of Botox are FDA-approved but off-label use is commonly triple or more. Are we the human guinea pigs?

20 units is the most frequently used dose for frown lines. Some people require slightly more if they have very strong muscles. When patients are receiving 60 units of Botox, this involves treatment of other areas of the face in addition to the frown lines. This, too, is a safe dose in healthy people. In terms of viewing patients as a guinea pig, I would never recommend a treatment to a patient that I wouldn't also perform for a family member, friend or colleague. I hope this information is helpful for you.

Stephen Weber MD, FACS
Denver Facial Plastic Surgeon

BOTOX UNITS

The Botox it is very safe, and those 20 units are the average amount needed for the frown lines, the range can be from 10 to 20 units. The Botox can be used for other areas at the same day, and that will increase the total amount of units used, but it is still safe. The lethal dose for a mouse is very different from a human as it is related to the weight, so for a human the lethal dose will be around 4000 to 5000 units, something that will be too expensive to do.

Off label higher doses of Botox and other areas of face (besides glabella/crows) are safe and have been used for over 10 years

The FDA approved doses for cosmetic purposes are 20 units for the glabella and 24 units for the crows feet.  Thousands of doctors have been using Botox in others areas of the face and it is safe.  FDA trials are very expensive for the companies so they prefer not to do them.  They can't market for use in any area it is not FDA approved.  I believe that 3000 units is needed of Botox in humans to cause Botulism, so cosmetic doses of less than 200 are very safe.  There are hundreds of clinical papers discussing the dosing in "off label Botox" and its safety by physicians, not the company.  

Steven F. Weiner, MD
Panama City Facial Plastic Surgeon
4.6 out of 5 stars 27 reviews

Botox is safe and effective.

That is incorrect.  Botox is approved to be administered 200 units at one time at the most.  Multiple studies in peer-reviewed journals are available that support the safety of all three of the botulinum products on the market today.

Corey L. Hartman, MD, FAAD
Birmingham Dermatologic Surgeon
5.0 out of 5 stars 10 reviews

How many units of Botox can be used

This is hard to answer other than to say "experience" which isn't all that convincing. Most of the time when an FDA study is done it is for a very specific thing. They don't go to the FDA with a product and say "how many units can we use?" They go in and say "we want approval for the glabella area specifically and for 20 units." And then this is what is tested only. Ultimately doctors and clinicians and such will extrapolate out from this what can be used safely and how the approved item can be used in other ways. For instance, Botox is often used on the crow's feet and the forehead, but it wasn't until last year that Allergan went back to the FDA for approval for the crow's feet. And this was only after its competitor Dysport had already done it (and was why they spent the money to do so!). I know that's not a convincing way to explain it, but millions of treatments have been done and the majority of these would have been outside the 20 unit realm for the glabella. As doctors and clinicians we are constantly learning and changing techniques based on each other's experiences, education, and trainings. And that doesn't mean the practices are always exactly in line with what is FDA approved. You certainly don't have to get Botox, and you can absolutely just get what is FDA approved for 20 units for the glabella.

"This answer has been solicited without seeing this patient and cannot be held as true medical advice, but only opinion. Seek in-person treatment with a trained medical professional for appropriate care."

Only 20 units of Botox are FDA-approved but off-label use is commonly triple or more. Are we the human guinea pigs?

Hi, I think this is a reasonable question.  The facts are that millions of patients have been treated with Botox and the other neurotoxins for almost 30 years at this point.  For the aesthetic indications, these neuro-modulators have proven to be safe and highly effective.  There's nothing experimental about having reasonable doses of Botox to the forehead (20-50 units).  Hope this helps.

Francis R. Palmer, III, MD
Beverly Hills Facial Plastic Surgeon
4.6 out of 5 stars 24 reviews

Botox and Dosing

Botox is extremely safe at cosmetic doses.  It is used at much higer doses for neck spasm and other muscular/neurological conditions with great results.  It has been on the market for over 20 years with very few issues.  Best, Dr. Emer.

Jason Emer, MD
Los Angeles Dermatologic Surgeon
4.9 out of 5 stars 165 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.