Botox: What is it and What Are the Risks?

Botox: What is it and what are the Risks?

INTRODUCTION
Clostridia botulina bacteria produce a class of chemical compounds known as
“toxins”. The Botulina Type A Toxin (BOTOX, Allergan) is processed and purified to
produce a sterile product suitable for specific therapeutic uses. Once the diluted
toxin is injected, it produces a temporary paralysis (chemodenervation) of muscle by
preventing transmission of nerve impulses to muscle. The duration of muscle
paralysis generally lasts for approximately three to four months. Continuing
treatments are necessary in order to maintain the effect of BOTOX over time.

BOTOX has been approved to treat certain conditions involving crossed eyes
(strabismus), eyelid spasm (blepharospasm), cervical dystonia (spastic muscle
disorder with the neck ) and motor disorders of the facial nerve (VII cranial nerve).
As of April 2002, it has been FDA approved for the cosmetic treatment of forehead
wrinkles caused by specific muscle groups. Other areas of the face and body such as
crows feet wrinkles and neck bands may be treated in an “off-label” fashion. BOTOX
has also been used “off-label” to treat migraine headaches, colorectal disorders,
excessive perspiration disorders of the armpit and hands, and musculoskeletal pain
disorders.

BOTOX injections are customized for every patient, depending on his or her particular
needs. These can be performed in areas involving the eyelid region, forehead, and
neck. BOTOX cannot stop the process of aging. It can, however, temporarily diminish
the look of wrinkles caused by muscle groups. Botox injections may be performed as
a singular procedure or as an adjunct to a surgical procedure.

ALTERNATIVE TREATMENTS
Alternative forms of management include not treating the skin wrinkles by any
means. Improvement of skin wrinkles may be accomplished by other treatments or
alternative types of surgery such as a blepharoplasty, face or brow lift when
indicated. Other forms of eyelid surgery may be needed should you have intrinsic
disorders affecting the function of the eyelid such as drooping eyelids from muscle
problems (eyelid ptosis) or looseness between the eyelid and eyeball (ectropion).
Minor skin wrinkling may be improved through chemical skin-peels, lasers, injection of
filling material, or other skin treatments. Risks and potential complications are
associated with alternative forms of medical or surgical treatment.

RISKS of BOTOX (Botulina Type A Toxin) Injections
Every procedure involves a certain amount of risk, and it is important that you
understand the risks involved. An individual’s choice to undergo this procedure is
based on the comparison of the risk to potential benefit. Although the majority of
patients do not experience the following complications, you should discuss each of
them with your physician to make sure you understand the risks, potential
complications, and consequences of BOTOX injections.

Bleeding- It is possible, though unusual, to have a bleeding episode from a BOTOX
injection. Bruising in soft tissues may occur. Serious bleeding around the eyeball
during deeper BOTOX injections for crossed eyes (strabismus) has occurred. Should
you develop post-injection bleeding, it may require emergency treatment or surgery.
Do not take any aspirin or anti-inflammatory medications for seven days before
BOTOX injections, as this may contribute to a greater risk of a bleeding problem.

Damage to deeper structures- Deeper structures such as nerves, blood vessels, and
the eyeball may be damaged during the course of injection. Injury to deeper
structures may be temporary or permanent.

Corneal exposure problems- Some patients experience difficulties closing their
eyelids after BOTOX injections and problems may occur in the cornea due to dryness.
Should this rare complication occur, additional treatments, protective eye drops,
contact lenses, or surgery may be necessary.

Dry eye problems- Individuals who normally have dry eyes may be advised to use
special caution in considering BOTOX injections around the eyelid region.

Migration of BOTOX- BOTOX may migrate from its original injection site to other areas
and produce temporary paralysis of other muscle groups or other unintended effects.
BOTOX has been reported to cause swallowing problems in patients treated for
spastic muscle disorders of the cervical region (cervical dystonia)

Drooping Eyelid (Ptosis)- Muscles that raise the eyelid may be affected by BOTOX,
should this material migrate downward from other injection areas.

Double-Vision- Double-vision may be produced if the BOTOX material migrates into
the region of muscles that control movements of the eyeball.

Eyelid Ectropion- Abnormal looseness of the lower eyelid can occur following BOTOX
injection(s).

Other Eye Disorders- Functional and irritative disorders of eye structures may rarely
occur following BOTOX injections.

Blindness- Blindness is extremely rare after BOTOX injections. However, it can be
caused by internal bleeding around the eyeball or needle stick injury. According to
Allergan, the company that produces BOTOX, over a period of 10 years of BOTOX
administration, complications of blurred vision, retinal vein occlusion, and glaucoma
have been reported in three patients. The occurrence of eye problems appears to be
very rare.

Asymmetry- The human face and eyelid region is normally asymmetrical with respect
to structural anatomy and function. There can be a variation from one side to the
other in terms of the response to BOTOX injection.

Pain- Discomfort associated with BOTOX injections is usually of a short duration.

Unsatisfactory result- There is the possibility of a poor or inadequate response from
BOTOX injection(s). Additional BOTOX injections may be necessary. Surgical
procedures or treatments may be needed to improve skin wrinkles including those
caused by muscle activity.

Allergic reactions- As with all biologic products, allergic and systemic life-threatening
anaphylactic reactions may occur. Allergic reactions may require additional
treatment. Systemic anaphylactic reactions require immediate medical care.

Antibodies to BOTOX- Presence of antibodies to BOTOX may reduce the effectiveness
of this material in subsequent injections. The health significance of antibodies to
BOTOX is unknown.

Infection- Infection is extremely rare after BOTOX injection. Should an infection
occur, additional treatment including antibiotics may be necessary.

Long-term effects- Subsequent alterations in face and eyelid appearance may occur
as the result of aging, weight loss of gain, sun exposure, or other circumstances not
related to BOTOX injections. Future surgery or other treatments may be necessary.
BOTOX injection does not arrest the aging process or produce permanent tightening
of the eyelid region. Continuing treatments are necessary in order to maintain the
effect of BOTOX over time.

Pregnancy and nursing mothers- Animal reproduction studies have not been
performed to determine if BOTOX could produce fetal harm. It is not known if BOTOX
can be excreted in human milk. It is not recommended that pregnant women or
nursing mothers receive BOTOX treatments.

Drug Interactions- The effect of BOTOX may be potentiated by aminoglycoside
antibiotics or other drugs known to interfere with neuromuscular transmission.

Skin disorders- Local or systemic skin rash, itching, and swelling may rarely occur
following BOTOX injection.

Neuromuscular disorders- Patients with peripheral motor neuropathic disorders
(amyotrophic lateral sclerosis, myasthenia gravis, motor neuropathies) may be at
greater risk of clinically significant side effects from BOTOX.

Migraine headache and other medical disorders- BOTOX has been used to treat
forehead muscle groups that are involved with the migraine headache condition.
Patients are advised that results of off-label BOTOX treatment for migraine
headaches and other medical disorders may be variable and improvement may not
occur following BOTOX treatments.

Unknown risks- The long term effect of BOTOX on tissue is unknown. The risk and
consequences of accidental intravascular injection of BOTOX is unknown and not
predictable. There is the possibility additional risk factors may be discovered.

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