Botox and Headache Prevention

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Many of my headache patients ask if Botox would help their headaches. This newsletter will focus on Botox and its role in headache prevention. A patient testimonial will be included. I hope this newsletter will help you decide if Botox makes sense for you.

What is Botox?
Botox is Botulinum Toxin Type A. It is a neurotoxin used for greater than 20 years and is currently FDA approved for eye muscle conditions such as strabismus and blepharospasm and for a neck problem called cervical dystonia. The mechanism of action for these conditions is related to the muscle relaxing properties of Botox. It is not yet FDA approved for migraine or headache prevention; however recent clinical trials show promising results. Two recently completed clinical trials were done exploring the use of Botox for adults suffering from “chronic migraine”, i.e. headaches and/or migraine occurring on 15 or more days/month. The results of these 2 studies showed a decrease in the number of headache and migraine days. Additionally, the quality of life in patients receiving Botox in the studies improved significantly compared to patients receiving placebo injections.

For complete product and prescribing information, go to www.botox.com.

How is Botox injected for headache prevention?
Typically 100 units of Botox are injected in multiple sites over the forehead; around the eyes; the temples; the back of the neck and the upper back. The Botox comes in a 100 unit vial and I mix it with a saline solution prior to injection, yielding a concentration of 2.5 units per .1 cc. Then, I fill 5 small syringes, each containing 20 units of Botox. Very small 30 gauge needles are attached to the syringes and then the Botox is injected. There are certain fixed sites and amounts that I use for every headache patient and these include the forehead; the eye and the temples. The fixed sites require 65 units of Botox. With the remaining 35 units, I can “follow the pain” of where my patients experience most of their pain relative to their headaches and tailor the remaining Botox injections accordingly.

The vial of Botox is mixed fresh for each injection visit. There is no “sharing” of Botox with other patients. Each patient pays for and receives the equivalent of 1 full vial of Botox (100 units). Studies indicate that larger amounts (100-300 units) are required for headache prevention in contrast to cosmetic uses of Botox which often require much less quantity.

What are the risks of Botox injection?
The risks are minimal and include bruising, swelling and pain at the site of injection. There is a very slight risk of eyelid dropping which is reversible. An ice pack is applied prior to the forehead and facial injections which can lessen injection pain and prevent bruising and swelling.

To learn more specifics re: benefits/risks of Botox, click on www.imigraine.net.

How soon does it work?
From my experience, many patients feel almost immediate relief from the muscle tenderness part of their headaches, including the forehead, neck and upper back areas. This is due to the muscle relaxing characteristics of Botox. However, true migraine prevention results are not often evident for 2 weeks. The accepted theory on why Botox works to prevent migraine is that it prevents the release of some of the inflammatory agents that cause migraine such as CGRP and substance P.

How long does it last?
Most patients experience 12-14 weeks of benefit after Botox injection. Many comment they can tell when it starts wearing off by an increase in headache.

What is the cost?
Currently we charge a total of $825.00 for Botox injection. This fee includes 1 full vial of Botox (100 units); all related supplies such as needles and syringes; and the procedure cost. The time for the procedure is 30 minutes. In most cases, you can return to work after your injection.

Our policy is to offer insurance billing for Botox; however, we cannot guarantee it will be covered since it is not FDA-approved for headache prevention and is considered “experimental” and “off-label” by most insurance companies.

Patient Testimonial (a quote from one of Dr. Hutchinson’s patients)
“I am really pleased with the results! I felt a “softening” of the muscle tension in my forehead and the back of my neck right away and that has continued over the past week. As you indicated, it appears that the injections take some time to fully work. My forehead today feels better than it did over the weekend, and my shoulders and neck have not been as tense either. I am very satisfied with the results and feel that Botox can be another “weapon” in my arsenal to prevent migraines.”

How do I know if I am a good candidate for Botox for headache prevention?
If you are currently frustrated with your headaches, then Botox is a strong consideration. It is especially helpful, in my opinion, for those patients who have a muscle tension component to their headache, e.g. a lot of forehead/scalp or neck muscle tightness and tenderness. Also, based on the recent studies by Allergan (the maker of Botox), those with more frequent headaches, especially more than 15 days/month, would be good candidates for Botox injection for headache prevention.

Please call our office 949-861-8717 and set up an office visit to evaluate whether you would be a good candidate for Botox. I will review your current headache management as well as the pattern of your headaches and give you my opinion. If Botox makes sense, it can be ordered and the injections given 1-2 weeks later.

Sincerely,
Susan Hutchinson, MD Director-Orange County Migraine & Headache Center

New Treatment for Migraine

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The FDA just approved a new medication for the acute treatment of migraine. It is called Treximet and is a combination of Imitrex (a migraine specific medication) and Naproxen (an NSAID: Nonsteroidal anti-inflammatory medication). Treximet is the first drug of its kind on the market and represents an advancement in the acute treatment of migraine. It is now available in pharmacies.

Why was this combination brought to market?

To answer this question we need to look at what occurs during a migraine attack. Migraine is a neurovascular event and involves the release of neurochemical transmitters such as CGRP and Substance P. These neurotransmitters cause inflammation and vasodilation of blood vessels surrounding our brain. The triptans (Imitrex; Relpax; Maxalt; Axert; Zomig; Frova; Amerge) prevent the release of these neurotransmitters and in turn, prevents the involvement of the blood vessels. They are most effective in taken early in this process.

We have now discovered another pathway involved in migraine that consists of the production and release of prostaglandin. The NSAIDs (nonsteroidal anti-inflammatory medications) inhibit prostaglandin production and release and include medications such as Motrin, Aleve, Advil, and Naprosyn.

Therefore, it makes sense to combine these 2 drugs to attack the multiple pathways involved in migraine. The combination should potentially be more effective than either agent alone.

Why not just take an OTC NSAID like Aleve or Advil with a triptan?

Taking the NSAID such as Aleve with the triptan may not be as effective. From extensive research studies and clinical trials, a unique pharmacokinetic profile is seen with the combination tablet. The Imitrex portion of the tablet reaches peak levels quickly, providing important initial relief; the Naproxen component of the tablet is delayed and reaches peak levels of concentration later than if given separately. This delayed release of the Naproxen provides the important headache prevention needed as the Imitrex begins wearing off. Therefore, most patients experience initial headache relief within 1-2 hours followed by sustained pain-free results for 24 hours.

Additionally, the combination tablet is convenient and eliminates the need to carry two separate medication bottles. Treximet will be packaged in a quantity of #9 tablets and is in a small container that will easily fit into a woman’s purse, e.g.

Who should not take Treximet?

Anyone who has established coronary or peripheral vascular disease should not take Treimet which contains Imitrex, a triptan medication. If an individual has cardiac risk factors such as high blood pressure of high cholesterol, they should be screened prior to triptan use. Anyone with a history of an allergic reaction of any of the triptan medications should not take Treximet. Anyone with a history of an allergy or contraindication to NSAIDs such avoid the use of Treximet which contains Naproxen, a NSAID. Contraindications would also include gastric ulcer; gastritis/esophagitis; history of gastric by-pass; and someone on Coumadin or other blood thinners. Pregnant women should avoid the use of Treximet. Full prescribing information is available at www.treximet.com.

How do I know if I should switch to Treximet? Answer these migraine treatment questions.*

  1. Do you want more relief from your migraine medicine?
  2. Do you ever need more than one dose of your current medicine to treat your migraines?
  3. Do you ever take more than one medication to relieve a single migraine attack?

If your answer was “yes” to 1 or more of these questions, then you may benefit from Treximet. It may provide more complete relief for your migraine headaches. In addition, you may be less likely to re-dose or rescue compared to your current acute headache treatment. Complete relief of head pain and associated symptoms such as nausea within a 2 hour time period is a reasonable expectation followed by sustained pain free for at least 24 hours.

*Migraine Treatment Questionnaire developed by GlaxoSmithKline Pharmaceutical and recognized by the National Headache Foundation as an effective way to initiate dialogue between healthcare professionals and patients regarding treatment effectiveness. Printed with permission from GSK Pharmaceutical.

How do I know if Treximet better than my current triptan or other acute headache medication? Answer the following questions.

  1. Are you headache free in 2 hours and back to full function?
  2. Are there any side-effects on the medication?
  3. Do you need to re-dose within 24 hours?
  4. Do you have to rescue with another medication?
  5. Does the headache stay away completely for at least 24 hours? (Sustained pain-free)

In summary, Treximet is the newest prescription medication on the market for the acute treatment of migraine with or without aura in adults 18 and older. The combination of Imitrex/Naprosyn represents the most migraine specific medication now available. Schedule an appointment with Dr. Hutchinson or your primary care provider to see if Treximet would be right for you.

Sincerely,
Susan Hutchinson, MD Director-Orange County Migraine & Headache Center