What Does An Off-Label Use Of Botox Mean?
Q: Dr. Eppley, I recently had Botox injected into my lips to help treat my lip lines. I was not pleased with the results at all. Besides not getting rid of any of the wrinkles it also gave me the unhappy effect of making my upper lip look funny (not in a good way) when I smile. I happened to have heard on my way out when paying my bill that this was the first time the doctor had ever injected Botox into a lip. I am upset that I paid for not only no result but that it may me look worse. On my own investigation I read on the internet that Botox is only approved for use in the forehead. I think I should get my money back and maybe even sue the doctor. What do you think?
A: Botox is used for a wide variety of aesthetic facial applications. It was initiallystudied and subsequently cleared by the FDA for glabellar (between the eyebrows) wrinkles and is known as an ‘on-label’ use. Despite this one approved cosmetic use in the face, it is a perfectly acceptable medical practice to use Botox for numerous other expression-reducing/wrinkle reduction indications. This is known as ‘off-label’ use and is commonly done with many drugs. It is neither wrong nor malpractice to do so. The use of Botox in the upper lip can be effective at wrinkle reduction but is technique and dose sensitive. Unfortunately for you, this effort did not turn out to produce the desired effect. The good news is that your Botox will wear off in a few months and you will return completely to normal. I would discuss your dissatisfaction with the treating doctor and see what accommodations they may be willing to do.
Dr. Barry Eppley
A detailed description and pictures of your concerns allows for the most informed response.