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2336 Sylvan Ave #C, Modesto, CA 95355.  (209) 551-1888


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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 physicianís 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 wasnít 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 isnít 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.

Juvederm History and the FDA

Juvederm obtained FDA approval for nasolabial (parenthesis between nose and mouth of the face) folds in 2006, and Juvederm XC obtained similar FDA approval in 2012.

Safety Information from Allergan's Juvederm website


 

Dr. Calvin Lee's procedures with Botox and Juvederm:

These were already mentioned in my home page

Botox:

  • facial wrinkles "11's"

  • crows feet wrinkles on the face besides the eyes

  • forehead wrinkles

  • jowls

  • chin dimpling

  • excess gum show (teeth)

  • nasal flare

  • migraines

  • headaches

  • muscle pain

  • trigger points

  • TMJ (tight jaw muscles)

  • neck bands (vertical bands on the neck in the front)

  • lines around the mouth (ie. smoker's lines above and below the lips)

  • eye twitching

  • blepharospasm

  • hyperhidrosis (arm sweating)

  • palm sweating

  • feet sweating

Juvederm (injectable gel implants):

  • folds on the face (such as nasolabial folds - parethesis around the mouth)

  • hand rejuvenation - including plumping.  We also do vein removal with sclerotherapy - this is different from Juvederm procedure

  • indented scar filling

  • nose reshaping

  • lip augmentation

  • under the eyes (ie. tear trough)

  • chin/cheek reshaping

  • lines around the mouth.

 

Disclaimer:  Policies change from time to time, please check other resources for updates.  Furthermore, this is my personal interpretation of information that is available at this time.  Please confirm for yourself with other resources.


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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