Turn on the television or open-up a magazine today and there staring back at you is likely an advertisement for botox. It seems like a day doesn't pass without me hearing about this treatment and the wonders it can do for facial wrinkles and other minor imperfections that I might want to get rid of. However, while botox treatment is "non-surgical" it does come with some inherent risks. Additionally, doctors today are using it for all sorts of "off-label" uses which can easily increase your risks if you aren't careful.



Why was Botox approved by the FDA?

Botulinum is a neurotoxin which was approved by the FDA in 1989 for treating crossed eyes and eyelid tics. Surprisingly, Botulinum is on the list of Homeland Security's list of potential agents of bioterrorism because of its powerful neurotoxicity. However, it's this same property which makes it effective in the fight against wrinkles, when used in a safe and controlled environment.

With the initial FDA approval of Botulinum for crossed eyes and eyelid tics, it opened up a whole new world of what are referred to as "off-label" uses. When the FDA approves a drug for use, it also gives physicians a liberal usage of that substance for other uses which are not the ones which it was approved for. This is referred to as "off-label" usage.

The Most Popular Off-Label Uses for Botox

Because botox works by paralyzing muscles and thus relieves muscle spasms, it's most common off-label uses include treatments for neck pain, back pain, bladder spasms, migraine headaches, and many other ills caused by muscle contractions. It was from some of these uses that the correlation between wrinkle removal and botox was born.

The 2002 Botox Approval for Glabellar Lines

In 2002, the FDA approved Botulinum for cosmetic surgery was used to treat glabellar lines, or wrinkles which form between the eyebrows. Many patients remain unaware about the temporary effects of the procedure that ensures repetitive treatment necessity. While this caused a surge in popularity of the drug, it also opened up door to many plastic surgeons and other physicians working with botox for other similar off-label uses, such as forehead wrinkles, crow's feet, lip area wrinkles and even those on the neck.

Botulinum is a fast moving drug benefiting both the doctors and manufacturers. The main problem with off-label usage of any drug is that the long-term studies have not been conducted to prove that they are safe. So, while patients are flocking to their plastic surgeons to get botox injections to alleviate their entire facial and neck wrinkles, it has only been approved by FDA to treat glabellar lines. Thus it can be used in a very limited amount. The jury is still out on the long-term issues which may be caused by using more of the substance than it was approved for. For this single reason, you should always think long and hard when you are considering botox injections for yourself. It is always better to error on the side of caution than to overdo it.