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Keith Denkler M.D.
Plastic and Reconstructive Surgery
415-924-6010
275 Magnolia Ave.
www.PlasticSurgerySF.com
Larkspur, CA 94939
kdenklermd@hotmail.com
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- BOTOX®
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BOTOX® FOR WRINKLES AND HEADACHES BOTOX® belongs to a class of drugs called botulinum toxins. BOTOX®, a focal agent intended to reduce muscle contraction, is the brand of botulinum toxin type A made by Allergan. BOTOX® is the most studied brand of botulinum toxins and has been helping patients worldwide for more than 15 years. This section is designed to help you understand the way BOTOX® works, its effectiveness, and its side effects. The potential of BOTOX® for continued use is also discussed. You may find it helpful to bookmark this site for future reference. The FDA tightly controls botulinum toxin production. Meticulous quality control ensures proper dosing in each vial. Use for migraines is a new physician after-market use, as the FDA currently does not approve the use of BOTOX® for headaches. Current phase III studies for submission to the FDA have shown significant reduction in the number and severity of headaches after injection of Botox into the glabellar and forehead areas. This data was presented at the American Assocation for the Study of Headaches meeting in 1999 by Dr. Klapper. The study involved 123 migraine patients. A significant reduction in headaches was noted after the first month and the amount of headache medication used significantly dropped. The mechanism of action is unknown. There may be a feedback loop from the brain to the facial and temporal muscles. The only side effect was drooping of the brow with higher doses of BOTOX® i.e. 75 units rather than 25 units. Another study at UCLA by Dr. Binder showd that out of 96 patients, 49 showed complete improvemnt of their pain, 27 showed partial improvement, and 20 showed no improvement. BOTOX® only provides temporary relief for approximately 3 to 6 months. The body overcomes the effect of the toxin and the muscles recover. There do not seem to be any long-term side effects in children that have received BOTOX® more than 10 years ago for hyperactive eye muscles causing them to be cross-eyed. INTRODUCTION BOTOX® made by Allergan Pharmaceuticals is a strong toxins produced by the Clostridium botulinum bacteria. This historically deadly poison was first purified and used for medical use in 1973 to treat children with nystagmus or crossed-eyes. Subsequently, it was developed commercially by Allergan Pharmaceuticals and approved by the FDA for medical use in blepharospasm (involuntary contracture or spasm of eyelids) and nystagmus (crossed-eyes). The poison works locally and paralyzes the muscles contracting abnormally. In 1987 Dr. Alastair Carruthers, of Vancouver, B.C., first used BOTOX® cosmetically to treat the frown lines on his medical assistant. About the same time a neurologist in New York, Dr. Mitchell Brin a neurologist noticed the same effect. In April of 2002, Botox was approved by the FDA for cosmetic use. Since it has been an approved medical product for more than a decade for blepharospasm and nystagmus treatment, its use in cosmetic purposes was off label. In April of 2002 the FDA for cosmetic use approved it. Companies are now able to advertise its use to patients and market the product to physicians. BOTULISM Botulism is food poisoning, caused by uncontrolled large doses of botulinum toxin. BOTOX® and MYOBLOCK® are medicines produced by the same bacteria and carefully controlled by the FDA for quality control. BOTOX® is very useful for treatment of crow's feet, forehead lines, and frown lines. It can also be used for neck banding and drooping lateral mouth lines. Other uses include back pain, neck pain, or muscle spasticity. BOTOX®is a deadly poison in high concentrations; however, there have been no deaths reported after its clinical use of 25 to 100 units of Botox per session. To have a toxic effect it has been estimated by Dr. Brin that one hundred thousand units would have to be used at a single setting. However, this would be extremely expensive, and it is unlikely that this would ever occur. HOW LONG DOES BOTOX® LAST? BOTOX® seems to last for about 3 to 6 months; however, in some patients it may last 9 to 12 months. Some patients are resistant to injections, and this small subset may need re-injections at about 2 to 4 weeks. Resistant patients are more commonly men. BOTOX® resistance is probably related to the larger muscle mass in male patients. WHO SHOULD NOT TAKE BOTOX®? Patients who should not get BOTOX® include, 1. Patients with a history of multiple sclerosis or myasthenia gravis. 2. Patients taking aminoglycoside antibiotics, such as Tobramycin or Gentamicin, or calcium channel blockers, such as Calan, Cardizem, Norvasc, Procardia, or Verelan. ARE THE SIDE EFFECTS? Side effects are few and can be related to localized trauma or bleeding from the injections. Some people report headaches in the first few days. DOES BOTOX® WORK FOR HEADACHES? BOTOX® has been very successful in the treatment of tension and migraine headaches. Although it is not approved by insurance companies or the FDA for this use, clinical results are very promising. Sometimes insurance companies will pay for its use in headaches. See the BOTOX® hotline number below. HOW DOES BOTOX® WORK? BOTOX® prevents the release of acetylcholine at the junction of the nerve with the muscle. This blocks the transmission of nerve signals to the muscle. The nerve senses that there is no communication and over time sends out new sprouts to reinnervate the muscle. That is why BOTOX® wears off slowly over a period of time. REACTIONS TO BOTOX®? There have been no true allergies to Botox. The doses used are so small that Antibody formation has been noted only with larger doses, such as 100 units, or with repeated booster injections. USE IN PREGNANCY BOTOX® use is not indicated in pregnant patients; however, it is not likely to cause any damage, since the chemical is too large to cross the placental membrane. PAIN OF INJECTION In an effort to reduce the pain of injection, ice cold or frozen needles are used, which have been shown in the Journal of the American Medical Association to dramatically reduce the pain of injections. This study, by Dr. Denkler, was published in JAMA Oct 3rd, 2001 and later referenced in the New York Times and Readers Digest. DOES BOTOX® ALWAYS GET RID OF THE WRINKLES? In patients with deep or severe wrinkles, the muscle will be smoothed out, but the wrinkle in the skin may continue. This can be treated with injections of collagen, dermabrasion, chemical peeling, or laser treatment. DOSING The standard cosmetic dosing for frown lines is 20 units and for crow's feet it is 12.5 to 20units. Forehead frown lines require another 20 units. Since the price of the injections is very much related to the cost of the medicine, make sure you are comparing equivalent unit doses when comparing prices. EXCESSIVE SWEATING Some people experience inappropriate or excessive sweating of the hands or axilla. BOTOX® is very effective for blocking the nerve transmission that causes this problem.
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