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Is Botox For Migraines Fda Approved

In the past, Botox has typically been used to treat wrinkles, but new research is showing that it might be beneficial for people with migraines too. This treatment is not yet FDA approved, but it may become available if your doctor thinks the benefits are worth trying. Keep reading to see what true migraine sufferers think about botulinum toxin injections.

The FDA approves the use of Botox to treat chronic migraine in adults who are age 18 or over. Botox is considered an “off-label” treatment if it’s used for children or adolescents. This means that a doctor can prescribe it, but insurance companies might not pay for it

Read on to learn more about Is Botox For Migraines Fda Approved, botox injections for migraines side effects
how to qualify for botox for migraines

Is Botox For Migraines Fda Approved

Is Botox For Migraines Fda Approved

We’ve all heard of Botox, responsible for generations of smooth foreheads in Hollywood. But Botox has also brought relief to many people who suffer from chronic medical conditions. In 2010, Botox was approved for use with chronic migraine, and many patients are reporting success. What do you need to know before considering it?

What Type of Headache Responds Best to Botox?

Botox is only FDA-approved for chronic migraines, which means headache on 15 or more days a month.  “The more frequent the headaches, the better the patient does with Botox,” says Dr. Andrew Blumenfeld, Director, The Headache Center of Southern California. Botox is not recommended for patients who experience fewer than 15 headache days a month.

What is Botox?

Botox is a form of botulinum toxin, a neurotoxin produced by the bacteria that causes botulism. When the Botox botulinum toxin is purified and used in tiny doses in specific areas, it temporarily reduces muscle contractions for approximately 3 months.

How Does Botox Work?

Botox is injected around pain fibers that are involved in headaches. Botox enters the nerve endings around where it is injected and blocks the release of chemicals involved in pain transmission. This prevents activation of pain networks in the brain.

Botox prevents migraine headaches before they start, but takes time to work. “I look to the second and third treatments to maximize effects,” says Dr. Andrew Blumenfeld. “Patients see in

creasing benefit with an increase in the number of treatment cycles.” One treatment lasts for 10-12 weeks, and patients reported that two Botox treatments reduced the number of headache days by approximately 50%.

Who Uses Botox?

The FDA approves the use of Botox to treat chronic migraine in adults who are age 18 or over.  Botox is considered an “off-label” treatment if it’s used for children or adolescents. This means that a doctor can prescribe it, but insurance companies might not pay for it.

Finding a Doctor Who Treats Migraine with Botox

If you want to try Botox for migraine, you should look for a headache specialist or neurologist. We recommend using your insurance’s doctor listing, Yelp, or the American Migraine Foundation’s doctor database.

Dr. Laura Banks, neurologist at Natividad Medical Center, suggests asking prospective doctors where they learned to give Botox, and how many times they’ve given it. “You’re looking for a lot of experience,” she says. Dr. Andrew Blumenfeld suggests asking doctors how many injections they will give, and where they will give them.

Getting Botox Treatment Paid for by Insurance

In general, the FDA-recommended dosage of 155 units costs between $300 to $600 for each treatment. Because Botox is FDA approved for chronic migraine, it’s covered by most plans, including Medicare and Medicaid. Allergan offers a “Botox Savings Card,” which offers patients reduced fees.

Please note that before your insurance company will approve Botox as a treatment for your chronic migraine, you typically must have tried and failed to respond to two other preventative treatments. These might include anti-seizure medications, antidepressants, or blood pressure medications that are typically used to prevent migraine.

What is Treatment Like?

When you receive your first Botox treatment, expect the appointment to take about 20 minutes. The doctor uses a very small needle that feels like a pinprick. He or she injects small amounts of Botox into shallow muscles in the skin. Each treatment typically involves 31 injections in seven key areas of the head and neck.

The most common side effect from the Botox shots is a sore neck, and we recommend using an ice pack to reduce the discomfort.

It can take up to six months to see the maximum benefit from Botox. In the meantime, you can continue your regular medications with no risk of a drug interaction.

How to use behavioral treatment to combat migraine and other diseases that cause severe head pain

One of the most challenging aspects of living with migraine is living with the pain. While there are many medications that have been shown to ease discomfort, there are additional lifestyle changes that can reduce the frequency and intensity of migraine. From relaxation techniques and cognitive therapy, to yoga and meditation, understanding behavioral treatment options may be a step to finding long term relief.

3 Types of behavioral treatment

Relaxation training, biofeedback training, and stress-management have been used widely over the last two decades. These treatments are meant to prevent migraine, not necessarily ease symptoms if your migraine has already started. While it doesn’t work for everyone, 30-60% of all patients who use biofeedback, relaxation, or cognitive-behavioral therapy experience fewer headaches than before they started. It is especially effective for those living with anxiety, depression, or who would like to take less medication.

Cognitive-behavioral therapy and how it works in treating people with migraine

Cognitive-behavioral therapy, or CBT, is a treatment option that aims to change the way you think about difficult situations, and therefore change the way you feel. It’s used not only for migraine, but also sleep issues, personal or work problems, and addiction. The short-term psychotherapy can be a great option for those averse to medication. CBT works to eliminate negative thoughts and turn them into something more productive, relieving anxiety, depression, and other things that can exacerbate head pain. PsychCentral says CBT “changes people’s attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.”

The role of depression and anxiety in behavioral migraine treatment

Behavioral treatments address issues like anxiety and depression, and thus may help ease migraine symptoms. CBT looks at your thought patterns. If you have a negative spiral of thought patterns, that can contribute to depression. If your thought patterns take you down the path of anxiety, that can manifest in a stress migraine. By looking at thought patterns and turning them into something more positive, CBT alleviates anxiety and depression, which can in turn reduce the frequency of migraine attacks.

To explore behavioral treatment, consider making an appointment with a psychologist who specializes in headache who can determine the right course of action. While behavioral migraine treatment isn’t always the solution, it has helped a large percentage of migraine patients ease the frequency of their headaches.

Treating migraine with neuromodulation devices

A relatively new concept in treating migraine is using neuromodulation devices instead of traditional headache medications. These devices are sometimes referred to as stimulators, although they often turn down brain activity rather than stimulate it. Neuromodulation devices can be electrical, temperature-altering, or magnetic, and while they can be portable, some require surgical placement. Right now there are three non-invasive neuromodulation devices that have been approved by the FDA for headache and are no longer considered experimental. Each of them is labeled by the FDA as “minimal risk,” meaning no significant side effects are known or expected.

FDA-approved neuromodulation devices

Transcutaneous Supraorbital NeuroStimulator

The first neuromodulation device receiving U.S. approval was a Transcutaneous Supraorbital NeuroStimulator (tSNS). Also called the Cefaly device, it is approved in Europe and Canada, too. This device, now in a smaller, revised stimulator called Cefaly 2, is temporarily placed on the forehead and turned on daily for 20 minutes to prevent migraine. The study leading to FDA approval showed a significant number of migraine patients who wore the device daily for the designated amount of time had at least a 50% decrease in headache days.

The Cefaly device electrically activates forehead nerves and creates a buzzing sensation. The signal goes into the brain turning headache pathways down slowly over time. This results in fewer headache days. The Cefaly is currently being studied for whether it might stop migraine acutely on an as-needed basis as well.

Cefaly 2 device
Image of the Cefaly 2 device

SpringTMS

The second approved device is a single-pulse transcranial magnetic stimulator, called SpringTMS or sTMS. This is a magnet placed on the back of the head and turned on for a split-second pulse, which usually has no side effects. Two pulses of the magnet stopped migraine with aura in around 40% of patients, so the FDA approved it for treating the pain of migraine with aura.

sTMS is in its third design, called the “mini,” and has also been found to stop the pain of migraine without aura and prevent migraine. sTMS is currently before the FDA to decide if the approved use of the device can be broadened to include migraine prevention. The preventive approach involves pulsing the magnet four times twice a day, plus extra pulses on an as-needed basis. It is already being used for this in the United Kingdom.

SpringTMS Mini Device
Image of the SpringTMS Mini device

gammaCore

The third FDA approved device is a non-invasive vagal nerve stimulator (nVNS), called gammaCore, and is also approved in Canada and Europe. This device is placed on the neck over a gel and turned on to electrically stimulate the vagus nerve for 90 seconds to two minutes—generally in two cycles—causing mild buzzing and twitching neck sensations. The FDA approved nVNS for stopping the pain of an acute cluster headache attack in patients with episodic cluster headache, and it has also shown promise in preventing cluster headache when given in two cycles three times per day, and in treating migraine. Further studies are underway exploring its future use.

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