2/3 OF BOTOX USE IN THE U.S. IS OFF LABEL. THIS IS UNETHICAL.
RECREATED EXAMPLE OF SUGGESTED DOSES IN UNITS FROM TOP INJECTORS ACROSS THE U.S.
Off label use of Botox is unethical, it has caused severe disability and death for many. Over 2/3 of Botox use in the United States is off label. Off label means that the use is NOT approved by the FDA. Botox is approved for only a few specific uses, which are listed below. If you have been injected for a condition or into an area outside of the list below, then you received off label Botox.
Allergan has paid millions of dollars in criminal fines for marketing off label use to their clients. The most well known case was in 2010, brought against them by the Attorney's office of Georgia. Allergan pleaded guilty and was ordered to pay $350 million dollars in criminal fines for illegally marketing Botox to children with cerebral palsy, and adults with severe headaches or pain.
Allergan has a solid history of indoctrinating their clients into believing that their product cannot cause botulism. They are guilty of issuing marketing materials that say that it is a "myth" that Botox causes botulism and that it is a "myth" that Botox is dangerous because it comes from a poisonous toxin.
In addition to injecting unapproved conditions or areas with Botox, off label use may also include injecting approved areas with MORE units of toxin than approved. For instance, the FDA approved dosage in units for glabellar lines, is 20 units. If you received for example, 35 units to glabellar area, then you received unapproved injections.
It should also be noted that often doctors, or injectors insist their patients come back for "touch up" appointments when the first dose did not achieve either the sought out patient outcome, or it caused an adverse reaction such as eye or cheek ptosis. This leads the injector to try and "correct" the disfigurement by injecting more product into the same or nearby areas to try and counteract the patient's concern. It is often at these appointments where clients have now received more product than approved by the FDA.
Lastly, very few doctors, nurse practitioners, and med spa injectors understand Botox dosing. Botox is dosed in Mouse Units or MU's. Mouse units is not a measurement of weight or volume, but instead based on a calculated "median" of the (LD50 for Swiss mice). LD50 is a toxicological term, of the amount of toxin (a lethal dose), given all at once to the mice that causes death 50% of the time.
Many injectors simply don't understand what mouse units even are, the fact is: when a person goes in for a typical cosmetic dosage and receives 50 units, then "You have received enough Botox in your face to KILL 50 MICE." (Ray Chester, civil trial lawyer)
It is not known the amount of Botox it would take to cause human botulism. We understand that the amount of Botox injected intramuscularly causing IBP - Iatrogenic Botulism Poisoning varies greatly from person to person. We have reports of illness from doses as small as 3-5 units, and others a greater doses.
Lastly, it is unknown in Allergan's study what happened to the rest of the mice that received lethal doses that didn't die. Did they suffer botulism? Were they debilitated? What about other factors that would play a role in how a body processes botulinum toxin? Factors such as a person's age, weight, gender, body ph, amount of physical activity, preexisting conditions, auto immune disorders, DNA mutations, genetic mutations/dispositions, medications, etc. All of these things may play a critical role in how botulinum toxin reacts in a person's body.
(Please see our post "Botulinum Toxin Type A Kills" for more information and resources on Botox dosing.)
BOTOX LICENSED APPROVALS
BOTOX THERAPEUTIC
Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1)
Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) (1.2)
Treatment of upper limb spasticity in adult patients (1.3)
Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain (1.4)
Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients (1.5)
Treatment of blepharospasm associated with dystonia in patients ≥12 years of age (1.6)
Treatment of strabismus in patients ≥12 years of age (1.6)
1.1 Detrusor Overactivity associated with a Neurologic Condition BOTOX (onabotulinumtoxinA) for injection is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
1.2 Chronic Migraine
BOTOX is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer).
Important limitations
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.
1.3 Upper Limb Spasticity
BOTOX is indicated for the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris) and finger flexors (flexor digitorum profundus and flexor digitorum sublimis).
Important limitations
Safety and effectiveness of BOTOX have not been established for the treatment of other upper limb muscle groups, or for the treatment of lower limb spasticity. Safety and effectiveness of BOTOX have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX is not intended to substitute for usual standard of care rehabilitation regimens.
1.4 Cervical Dystonia
BOTOX is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
1.5 Primary Axillary Hyperhidrosis
BOTOX is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.
Important limitations
The safety and effectiveness of BOTOX for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of BOTOX have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.
1.6 Blepharospasm and Strabismus
BOTOX is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.
BOTOX COSMETIC
BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of (1):
Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
Moderate to severe lateral canthal lines associated with orbicularis oculi activity
Moderate to severe forehead lines associated with frontalis muscle activity ______________DOSAGE AND ADMINISTRATION _________________
BotoxCosmetic is administered by intramuscularinjection
Glabellar Lines Administration: 0.1mL(4Units) into each of 5 sites, for a total dose of 20 Units (2.3)
Lateral Canthal Lines Administration: 0.1mL(4Units ) into each of 3 sites per side (6 total injection points), for a total of 24 Units (2.3)
Forehead Lines Administration: 0.1 mL (4 Units) into each of 5 forehead line sites (20 Units) with 0.1 mL (4 Units) into each of 5 glabellar line sites (20 Units), for a recommended total of 40 Units (2.3)
Follow dosage and administration recommendations. In treating adults for more than one approved indications with BOTOX and BOTOX Cosmetic, do not exceed a total dose of 400 Units administered in a 3 month interval (2.1)
BOTOX LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf
APPROVAL DATES VIA FDA (THIS IS NOT A COMPLETE LIST)
Cervical Dystonia - 12/21/2000
Glabellar Lines- 4/12/2002
Primary Axillary Hyperhidrosis 07/19/2004
Upper Limb Spasticity 09/2009
Prophylaxis of Headaches - Chronic Migraine 10/14/2010
Urinary Incontinence (due to detrusor overactivity, associated w/ neurologic conditions i.e. spinal cord injury or ms) *patients are a candidate only if they have had inadequate response to anticholinergic meds. 08/24/2011
Expansion of existing upper limb spasticity in adults to include - thumb flexors, Max dosage 400U (updated) 07/17/2014
Upper/lower limb spasticity pediatric 2-17 years 12/20/2018
Eyelid Edema (following perivascular injection) 09/13/2020
SOURCE:
Approvals via FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103000
VIA BOTOX (THERAPEUTIC) LABEL
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX/BOTOX Cosmetic at the labeled dose of 20 Units (for glabellar lines) or 100 Units (for severe primary axillary hyperhidrosis) have been reported. (RECEIVING MORE THAN 20 UNITS FOR GLABELLAR IS CONSIDERED OFF LABEL)
No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX for blepharospasm at the recommended dose (30 Units and below), strabismus, or for chronic migraine at the labeled doses have been reported.
**Although the label states that "no definitive" serious adverses event reports of distant toxin spread have been proven, by THEIR studies. We know that MANY people have been harmed by toxin spread at FDA approved doses, or dosages much smaller.**
