Botox is the commercial name for Botulinum toxin, the most toxic protein on earth. Botox achieves its results by paralyzing muscles, just like snake venom. It is manufactured and sold by Allergan.
In the early 1800s, Justinus Kerner, a German physician, described botulinium toxin as “sausage poison” and “fatty poison” because the bacterium often grows in badly handled meat products.
Botox initially received FDA approval for treating excessive underarm sweating and for medical conditions related to spastic or painfully contracted muscles. In 2002, Botox received FDA approval for use in treatment of “moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 65 years of age”.
Glabellar lines are wrinkles that occur between the eyebrows, and their treatment is the only approved cosmetic use of Botox. That limited approval means that treating other conditions on the face, such as crow’s feet, is not an approved use.
Botox makes lines and wrinkles temporarily disappear, but requires repeated applications. The result? Botox parties now are the rage among fashion-conscious women. A celebrity doctor comes to a home and friends get together to have their faces jabbed with needles. Botox is so popular that it’s even earned a starring role in an episode of Law & Order.
Allergan’s sales of Botox have skyrocketed because of this off-label use by physicians. FDA regulations allow doctors to prescribe any legally available drug for other applications, and off-label sales make up a large part of many drugs’ uses.
Manufacturers cannot directly advertise an “off-label” use, but companies can pay doctors to give speeches and write articles about off-label uses. In the case of Botox, the off-label use, and profits, far exceed the approved use of this drug.
In addition to treating parts of the face other than glabellar lines, some physicians are using Botox to treat migraine headaches, although study results have found no conclusive benefits for migraines.
And, while Botox’s approval letter limited its use to “adult patients 65 years of age”, young girls are now using Botox treatments as a part of their pursuit of adolescent physical perfection.
Like any drug, Botox can have serious side effects, and people who use it frequently have seen their faces change in strange ways.
Allergan would like everyone to believe the product is 100% safe and effective, but recent studies and statistics are showing otherwise.
Dr. Arnold Klein, a Beverly Hills dermatologist and a strong advocate of Botox treatments, has accused Allergan of altering data to hide negative effects of the product.
The real unknown about cosmetic uses for Botox is the long term effect. Regular injections of the poison can result in the development of antibodies. Antibodies may make the treatment less effective and have other undesired effects, and a study has found that Botulinum toxin may migrate from the face to the brain.
In January of 2008, the first reports of deaths and serious personal injuries associated with Botox appeared, including permanent facial paralysis and palsy.
In 2009, more reports linking Botox to deaths have emerged, and the FDA has finally seen enough reports of damage to motivate the agency to require Allergan to place a Black Box warning on the label. A Black Box is the strongest possible warning about a drug’s potential dangers. A Black Box is the last step before the FDA bans a drug.
Botox is a powerful poison that can cause serious personal injury and even wrongful death in people who use it. Many Botox injections constitute unapproved uses of the drug, and if you or someone you know has suffered an injury because of the drug itself or because of improper injection procedures, contact me to learn if legal action can compensate for your injuries.
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