A brief discussion of
Off-Label Usage of Botox and
Juvederm
Role of the FDA
The Food and Drug
Administration (FDA or USFDA) is an agency of the United States Department of
Health and Human Services, one of the United States federal executive
departments. The FDA is responsible for protecting and promoting public health
through the regulation and supervision of food safety, tobacco products, dietary
supplements, prescription and over-the-counter pharmaceutical drugs
(medications), vaccines, biopharmaceuticals, blood transfusions, medical
devices, electromagnetic radiation emitting devices (ERED), veterinary products,
and cosmetics. (quoted from wikipedia)
A physician's judgment is important
The
FDA recognizes that off-label use of drugs by
doctors is often appropriate and may represent the standard of medical
practice in the United States. Botox and Juvederm are FDA approved
medications. Once approved, a drug or product may be prescribed by a
licensed physician for any use that, based upon the physician’s
professional opinion, is deemed to be safe and effective. "Any use"
includes on-label and off-label FDA usage.
Read about
Dr. Calvin Lee's medical background
from Ivy League Brown University and experience as a Surgeon (home page of
www.injectionartistry.com)
Most drugs are approved
for only their top one or two indications
It is common practice
for pharmaceutical companies to have their drugs approved for only one or two
major indications that seem to represent the most popular. It may take
hundreds of millions of dollars to get a drug approved for an indication.
Each indication needs a separate approval process that starts all over again,
and each time could take a decade or more. The probability of getting FDA
approval is less than 10% each time a drug is submitted. It's easy to
understand the reluctance of drug companies to seek approval of their drug for
every indication.
Pediatrics off-label
usage of drugs
Interestingly most
pediatric usages of medications are "off-label" FDA usages. This is most
likely because enrolling children as subjects of tests isn't the easiest thing
to do.
Botox History and the
FDA
Botox was initially
approved in 1989 for use in treating eye blepharospasm (muscle spasms around the
eye). It wasn’t until 2002 that the FDA approved it for treating skin wrinkles,
even though doctors started using it for this purpose in the early 1990s. I'm
writing this in 2012 and this is the 10th year anniversary of the FDA's specific
approval of Botox for a specific wrinkle in the face. The specific indication
regarding wrinkles is for the "11's between the eyes" (glabellar complex) and
the approval is for using 20U of Botox every 3 months. Other doses such as
using 16 Units of Botox which is also common isn't the FDA tested method, and
stretching it further or shorter than 3 months is not in line with the FDA
tested guidelines for Botox. Also using it for wrinkles other than the
11's between the eyes (Botox in our office is used for many different places on
the face) is also considered outside the realm of the FDA. Granted every
patient is different, I am glad that using a drug for an indication and in a
dosage/frequency that isn’t approved by the FDA is perfectly legal.
However, the Botox drug company (Allergan) can't have their Botox sales reps
talk freely about off-label usage.
Above is the specific FDA
locations for injections and there is also specifications as to how much at each
location (basically the same amount). I rarely inject in this robotic
fashion. Each patient is different, and I'd like to customize each
injection whenever possible. I also dilute Botox differently depending on
the purpose of Botox use.
Dr. Tammy Wu & Dr. Calvin Lee's
office in Modesto, California
Surgical Artistry |
(209) 551-1888
Please consider scheduling an
appointment with us.
Botox injections (as well as injected filler implants) are performed by Dr.
Calvin Lee, Board Certified Surgeon
2336 Sylvan Ave. Suite C
Modesto, CA 95355
Located next to the post office on Sylvan
Ave. in Modesto, California
[return to Dr. Calvin Lee's
Botox home page =
www.injectionartistry.com]
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Modesto, CA