Chronic Migraine Treatment

Botulinum toxin is effective for the treatment of chronic migraine. It has not been shown to be effective for any other headache type (e.g. episodic migraine, tension-type headache, cluster headache) as yet.

Indication

BOTOX® is a prescription medicine that is injected to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older.

It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

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What is botulinum toxin?

It is a toxin that is produced by bacterium, Clostridium botulinum,  it was isolated in 1895. Seven different subtypes of botulinum toxin (A-G) are known. A highly dilute preparation of botulinum toxin type A (Botox®) was introduced in clinical practice in the 1970s and 1980s to treat squint and blepharospasm. Since then it has found uses in other areas of medicine including treatment of wrinkles and hyperhidrosis. Other botulinum toxin preparations are available, both of type A (Dysport and Xeomin) and type B (Neurobloc or Myobloc).

Botulinum toxin and chronic headache

In the mid-1990s a number of people reported improvement in headaches in patients receiving botulinum toxin for other reasons. Botulinum toxin inhibits pain in chronic migraine by reducing the expression of certain pain pathways involving nerve cells in the trigeminovascular system. The trigeminovascular system is a sensory pathway thought to play a key role in the headache phase of a migraine attack.

Unlike many of the other conditions in which it is used, it is not thought to work by relaxing overactive muscles. Botulinum toxin has been shown to reduce pain in a number of disease states, including cervical dystonia, neuropathic pain, lower back pain, spasticity, myofascial pain, and bladder pain.

Botox® is usuallu well-tolerated, the commonest side effects being neck pain (6.7%), muscular weakness (5.5%), and drooping of the eyelid (3.3%). No serious irreversible side effects have ever been reported in trials of Botox® in headache.

Is Botox® right for me?

Only patients with chronic migraine are eligible for treatment with Botox®. Chronic migraine is defined as headaches occurring on 15 or more days each month, at least half of which have migrainous features. There are, however, other treatments available to patients with chronic migraine, and it is important that patients have an informed discussion of their headaches and the options for treatment with a practitioner experienced in the diagnosis and management of headaches before a decision to use Botox® is taken.

Side Effects

BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months

Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine.

BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX® if you: are allergic to any of its ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Serious and/or immediate allergic reactions have been reported including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.

Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.

Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; and drooping eyebrows.