Botox
What is Botox?
BOTOX is a formulation of botulinum toxin type A. It is derived from the
bacterium Clostridium botulinum. More than 100 years of research have expanded
our knowledge of botulinum toxin type A from the identification of the
bacterium Clostridium botulinum to the commercialization of botulinum toxin
type A as BOTOX.
In the 1960s, the muscle-relaxing properties of botulinum toxin type A were
tapped for investigational use in realigning crossed eyes. These early studies
paved the way for treating other conditions caused by overactive muscles with
botulinum toxin type A.
Today, BOTOX is produced in controlled laboratory conditions and given in
extremely small therapeutic doses. It has helped over 1 million patients
worldwide with conditions caused by overactive muscles.
Is Botox a new treatment?
No.
BOTOX has been used for more than 11 years to treat over 1 million patients
worldwide, and it is approved by the health ministries of at least 70 countries.
BOTOX
is Allergan's brand of botulinum toxin type A. A brand of botulinum toxin type
B is also now available. The two toxins are different in several ways:
·
They are different
serotypes
·
They have different
manufacturing processes
·
They work differently
·
They require different
doses
BOTOX
differs from oral therapies in that it is a non-systemic, focal therapy. When
drugs are taken orally, they are distributed throughout the body by the blood
system. The drugs reach not only their desired site of action but also many
additional sites. In contrast, BOTOX is administered directly into the desired
site of action. BOTOX is not expected to be present in the blood stream at
measurable levels following injection at the recommended doses.
BOTOX
provides targeted relief of symptoms for the treatment of neck pain and
abnormal head position in Cervical Dystonia with
·
No GI upset
·
No fatigue
·
No confusion
·
No depression
·
No liver toxicity
Over the past 20 years, BOTOX has been evaluated in more than 200 studies
specific to approved indications in the US. Currently, little clinical data are
published about botulinum toxin type B.
Normally,
your brain sends electrochemical messages to your muscles to make them contract
and move. These messages are transmitted from a nerve to the muscle by a
substance called acetylcholine. When too much acetylcholine is released,
muscles become overly active and spasm or tense up.
Each
treatment typically lasts 3 months and can be repeated as long as your
condition responds to BOTOX and you do not have any serious allergic reactions
or other significant side effects. BOTOX has been used for more than 11 years
to treat more than 1 million patients worldwide, and although formal, long-term
clinical evaluations have not been conducted, its safety in long-term use has
been well established.
Although most people continue to respond to BOTOX injections, some people have
experienced a diminished response over time. There may be several explanations
for this:
1.
Changes in your condition
- If the pattern of your muscle activity
changes, your health care provider may need to inject new muscles and/or change
your dose. Identifying and injecting the affected muscle can be difficult,
complicated by the changing pattern of muscle involvement and progression of
the disorder.
2.
Setting appropriate
expectations - You may believe your first
BOTOX injection was more helpful than subsequent injections. That's because
your condition was perhaps quite severe when you had your first injection.
Subsequent injections are usually given before your condition becomes that
severe again. Therefore, the relief you experienced with subsequent injections
may not have been as dramatic as the first time.
3.
Antibody formation - When foreign proteins, like botulinum toxins, enter your body,
antibodies may form. If antibodies to botulinum toxin develop, you may no
longer respond to treatment.
While
the critical factors for neutralizing antibody formation have not been well
characterized, you may be able to help maintain your response to BOTOX by
minimizing your total exposure. The potential for antibody formation may be
minimized by injecting with the lowest effective dose given at the longest
feasible intervals between injections.
BOTOX
is injected into the affected muscle(s). Your doctor will determine which
muscles need to be treated.
Some
people report minor, temporary discomfort from the injection. BOTOX is
reconstituted with sterile, preservative-free, normal saline for injection. The
neutral pH of the injected solution, in combination with the fine-gauge needle
your doctor will use, can help to minimize any injection-related pain.
If
you're receiving BOTOX, you'll usually see the effects within 2 weeks of the
injection. If you're receiving BOTOX for blepharospasm, you'll usually see
effects within 3 days.
BOTOX
offers sustained relief, dose after dose. The relief you'll feel from one
treatment of BOTOX will normally last for about 3 months. Treatments can be
continued as long as your condition responds to BOTOX, and you do not have any
serious allergic reactions or other significant side effects. When the relief
begins to fade, you'll return to your doctor for your next treatment.
Usually, BOTOX treatment is required approximately four times per year. Because
symptoms can change over time, the amount and duration of relief you'll
experience can vary. Consult your doctor, who can determine how to achieve the
best possible results with BOTOX.
The
most frequently reported adverse reactions in patients receiving BOTOX for the
treatment of cervical dystonia are dysphagia (difficulty swallowing, 19%),
upper respiratory infection (such as a cold or flu,12%), neck pain (11%), and
headache (11%). Dysphagia is a commonly reported adverse event following
treatment of cervical dystonia patients. In these patients, there are reports
of rare cases of dysphagia serious enough to require the insertion of a gastric
feeding tube (a tube for introducing nutritious, high-calorie fluids into the
stomach.)
The most frequently reported treatment-related adverse reactions in patients
receiving BOTOX for the treatment of blepharospasm are ptosis (droopy eyelids,
20.8%), superficial punctuate keratitis (inflammation of the cornea characterized
by small erosions of the tissue covering the cornea, 6.3%), and eye dryness
(6.3%). Reduced blinking from BOTOX injection of the orbicularis muscle can
lead to corneal exposure, persistent epithelial defect (a defect in the corneal
covering) and corneal ulceration (a hollowed-out cavity in the cornea),
especially in patients with VII nerve disorders.
In general, adverse reactions occur within the first week following injection
of BOTOX and, while generally transient, may last several months. Localized
pain, tenderness and/or bruising may be associated with the injection. Local
weakness of the injected muscle(s) represents the expected pharmacological
action of botulinum toxin. However, weakness of adjacent muscles may also occur
due to spread of toxin.
Please seek immediate medical attention if swallowing, speech, or respiratory
(breathing) disorders arise.
Your
health care provider can help you decide if BOTOX is right for you. In order to
make the right treatment decision, you should discuss the following with your
health care provider before choosing treatment:
·
Clinical experience with
the drug
·
Effectiveness and side
effects
BOTOX should be used with caution if you have other neurological diseases or
disorders, or if you are taking aminoglycoside antibiotics or other drugs that
interfere with neuromuscular transmission. Be sure to tell your health care
provider about any prescription or over-the-counter medications you are taking
before receiving BOTOX.
The
BOTOX ADVANTAGETM Program Reimbursement Hotline has been helping patients and
physicians get answers to their BOTOX reimbursement questions for years. In
addition, BOTOX has more than a decade of reimbursement experience with insurance
carriers and health care providers. It is this experience that has resulted in
BOTOX coverage by most payers, including Medicare and Medicaid; particularly
for cervical dystonia.
Some insurance plans cover BOTOX under the medical benefit and others cover
BOTOX under the pharmacy benefit. To find out how BOTOX is covered under your
insurance plan, call the BOTOX ADVANTAGETM Program Reimbursement Hotline,
toll-free, at 1-800-530-6680. Our knowledgeable Hotline staff is
available to assist you with your insurance coverage questions Monday through
Friday from 8:00 am to 6:00 pm ET.
Additionally, Hotline representatives will help physicians and patients
research alternative coverage for those who do not have insurance or cannot
qualify for government assistance. If the Hotline representatives cannot find
alternative coverage, they will help determine if patients meet the criteria
for the BOTOX Patient Assistance Program. The BOTOX Patient Assistance Program
is available to all patients who lack insurance coverage and demonstrate
financial need.
Dr. Richard Glogau, MD, UCSF professor of dermatology had produced a small
study of 24 patients and reported that 75 percent of patients in his case study
experienced 4 to 6 months of headache relief following injections of BOTOX
(botulinum toxin A) to muscles of the face and head in a presentation at the
American Society of Dermatologic Surgery meeting (held November 2-5). This adds
weight to previous reports that botulinum toxin A can relieve headaches. Two
previous studies were presented at the 1999 meeting of the American Association
for the Study of Headache. One study was reported by researchers at the
Michigan Head Pain and Neurological Institute in Ann Arbor and Michigan State
University spoke of dosage. Another study, reported by researchers at the
University of California, Los Angeles, reported 51 percent of 96 patients
reported complete improvement of their headache pain.
"I think it
was accepted pretty quickly," said Emory University neurologist Dr. David
Hewitt. "There are a number of people around the country who are using it
off-label to treat headache."
In using BOTOX to treat headaches and other severe headaches, there are still
some questions -- such as what is the optimal dose, and where should BOTOX be
injected to get the best results? Two large studies are under way at headache
clinics around the country that may provide those answers.
"BOTOX injection" or "botox shot" is the term most
widely used to describe the procedure of adminstering the Allergan BOTOX
Cosmetic treatement. BOTOX injections utilize Botulinum Toxin Type A to
treat wrinkles. BOTOX Injections were originally slated to treat
neurological disorders; today, BOTOX injections are widely used to remove
facial lines, especially frown lines, "crow's feet," and forehead
lines.
Migraine headache and associated headaches
such as muscle contraction and chronic tension headache and neck pain are all
potentially relieved with the use of BOTOX.
This medication was originally used to treat crossed eyes and later for
conditions such as blepharospasm and torticollis (twisting necks) . More
recently, BOTOX was used by cosmetic
surgeons to produce minor paralysis of facial muscles around the eyes and
smooth out wrinkles. Many of the patients reported significant relief of a
variety of types of headaches and various trials were instituted to prove that
it works for the treatment of headache.
Botulinum Toxin Type A is a new therapeutic
option for the preventive treatment of migraine and chronic tension type
headache. It offers several advantages over current drug therapy. Injections
are given in doses up to 100-300 units every three to four months. When it is
effective, the need for daily medications or acute medicines for severe attacks
are significantly reduced or entirely eliminated. There are few side effects
from the injections, except for minimal discomfort at the time of injection,
including a sensation of pinprick and a little burning with minor bleeding
which is likened to a mosquito bite. On rare occasions patients get
aching in injected muscles, usually just for a few days. I have now performed
over 1885 patient injections in more than 550 patients with an 75-87%
improvement rate.
Mechanism of Action
It is known that Botulinum toxin (BOTOX) can partially paralyze muscles.
Patients with blepharospasm and torticollis (so-called cervical dystonia) have
been treated and have had significant improvement in motor activity with
reduction of either the blepharospasm or the torticollis. What has been noted
is that there is often a reduction in pain that is more significant than the
motor effect and the pain effect lasts longer. It is quite likely that small
fibers containing pain-producing chemicals such as Substance P are affected by
Botulinum toxin. It is also likely that there are other mechanisms, not yet
understood, for the effect of Botulinum injections. None of these theories are
yet proven.
In the early 1990's, Dr. William
Binder, an Otolaryngologist who used Botulinum toxin for cosmetic purposes in
the muscles around the eye noted that a number of patients reported decreases
in migraine headache. Thereafter, gradually, the number of physicians using BOTOX for headache has increased. There
is significant clinical evidence now that Botulinum toxin type A (BOTOX) reduces
the pain in migraine, muscle contraction headache, chronic tension headache and
neck muscle spasm.
Muscles about the eyes and forehead are
injected with small amounts of Botulinum toxin. In our practice, usually the
muscles between the eyebrows and above the eyes are injected with approximately
4 units in each of 4-6 different injections. Thereafter, a series of three
injections are made around the outside of the eye on the side. Then injections
are made into the temporal region and sometimes the jaw where the masseter
muscle is located. These are the only injections made in patients who only
experience frontal pain with their headaches.
The majority of studies and treatment
patterns to date have been based on earlier experiences with blepharospasm in
which patients usually need to be reinjected every three months. However, there
are some unusual patients who need to have the blepharospasm muscles about the
eye injected only once every two years. After a patient receives a Botulinum
toxin injection, there may be an immediate effect just from the use of needles
into muscles. In a Scandinavian study, it was found that dry needle injections
into muscles such as trigger-point areas in fibromyalgia were significantly
improved even though nothing was injected for a period of up to one week. This
may be the initial effect sometimes seen in migraine patients. This effect is
the exception rather than the rule. Usually, patients do not begin to
experience relief from their headache for two to three weeks. Thereafter,
however, the effect may increase and have a duration of three to four months.
BOTOX
is a treatment for migraine. It works in chronic muscle
tension-type headache in up to 87 percent. It also is quite effective in some
patients who are not responding to any migraine preventive therapy. Our estimate
of effect in this population is 75 percent. Overall, this is believed to be an
effective, low risk treatment. In many instances this is a less expensive
alternative than chronic daily therapy or frequent use of triptan medication.
Nonetheless, BOTOX does
not work in every patient and alternative therapies must be kept in mind.
June 18, 2002 --
New research presented this week at the annual meeting of the American Headache
Society offers powerful evidence that the hottest thing in cosmetic medicine is
also a powerful new tool for preventing hard-to-treat chronic headaches. Some
13 studies involving more than 650 patients with migraines and frequent tension
headaches were presented at the Seattle meeting. Among the major findings:
·
Roughly 90% of patients in one study
did well on Botox, even though they had responded poorly to an average of three
other medications in the past.
·
The injections seem to be especially
useful for patients who experience more than 15 headaches a month and who get
little relief from standard treatments.
·
In one study, 68% of those who
responded had reductions in migraine-related disability of 75% or more.
Responders had an average decrease of 61% in headache frequency and 27% in
headache severity.