Why is Dysport and Botox being done on patients over the age of 65 if this not approved by the FDA?

I appreciate your question and your concern. While these treatments may not be approved by the FDA for use in patients over 65, that does not mean the procedures are not safe for that age group. It is more likely the clinical studies did not include patients over the age of 65. Physicians often work outside the FDA parameters when it is both safe and appropriate. As long as you work with a very experienced injector, you are very likely to see a very good result from your procedure.

Though Dysport has not been specifically approved by the FDA for use by those over 65 it can still be administered as an "off label" use.  Your doctor should discuss this with you prior to injection.  It is likely the guidelines stop at age 65 due to the lack of studies available in patients older than that.  I would encourage you to discuss the discomfort you are having with your eye with your injector as this is not a common side effect of the treatment.  

Hi and thank you for your question. It is likely that 65 is the age of the oldest person to have Dysport in the study for FDA approval. DFA guidelines are very stringent for toxins and fillers so most providers practice what is called "off label" treatments. There is no reason a patient overt 65 couldn't have Dysport unless they have underlining health problems already.  At any age, treatment concerns should be discussed with with your provider beforehand. We treat patients into their 80's with Dysport and Botox as long as they are healthy with no medical problems that would interfere. 

The FDA studies were done on an age group which was 65 and younger. It doesn't mean it doesn't work, it just mean that the FDA had to approve according to the study guidelines. It is perfectly fine and legal to treat "off label" in areas which haven't been approved or to age groups not approved. In fact, the only area approved for Dysport is glabella for cosmetic purposes, and it is used all over the face for injections. Fillers are similarly used in many areas and age groups which aren't approved. It would be very unusual to have any lasting pain from a Dysport injection. Please see a specialist to evaluate your pain. All Dysport injections are temporary and there is no permanent results from the injection.

use of many aesthetic and other products has certain FDA parameters. as long as your provider has discussed with you the FDA rules and informs you that this is an off label use and you agree its fine!i cant comment on the throbbing eye which is very strange. Good luck