FDA-Approved Prescription Medications to Prevent Migraine

Only a few prophylactic drugs used for migraine have this distinction

For more than a third of people who get migraines, trying to head them off is at least as important as treating them when they occur. But even though quite a few medications and natural remedies are prescribed by doctors for migraine prophylaxis (prevention), only eight are approved by the U.S. Food and Drug Administration (FDA) for this use.

Preventive migraine drugs aren't right for everyone, but studies suggest that fewer people who would benefit from them actually take them. If you think you may be in this group, talk to your doctor about exploring these FDA-approved medications. You may discover that when taken as directed, one of them will greatly decrease the frequency of your headaches and greatly increase your quality of life.

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Drugs Approved for Episodic Migraine Prevention

Episodic migraines are those that occur fewer than 15 days per month. The seven medications that have earned approval by the FDA for preventing them fall into three categories:

Beta-Blockers

These are drugs that originally were developed to treat hypertension (high blood pressure). Beta-blockers are thought to keep migraines at bay by blocking adrenaline, a hormone released during stressful situations that binds to blood vessels in the brain, causing them to constrict and leading to head pain. Beta-blockers relax these vessels, allowing for the free flow of blood.

Although there are many beta-blockers on the market, and several are regarded as safe and effective for preventing migraines, only two are approved by the FDA for this purpose:

  • Inderal (propranaolol), which also is sold under the brand name Innopran
  • Timolol, which is available as a generic only

Both are rated as Level A migraine prophylactic medications according to guidelines set jointly by the American Headache Society (AHS) and the American Academy of Neurology (AAN). This means they have been established as effective and should be offered to patients who would benefit from preventive therapy.

Beta-Blocker Dosage
Propranolol 120 to 240 milligrams (mg) a day
Timolol 10 to 15 mg, twice a day

Anticonvulsants

Also sometimes referred to as membrane stabilizers, these medications are primarily prescribed to prevent seizures. They work by blocking channels in the body that deliver electrical impulses to nerve, muscle, and brain cells. This action enhances the activity of gamma-aminobutyric acid (GABA), a neurotransmitter involved in regulating motor control, vision, and anxiety.

Researchers aren't certain how this process works to prevent migraine headaches, but it does so safely and effectively for most patients. The specific anti-seizure drugs that have FDA-approval for migraine prophylaxis are:

In order to reduce the risk of side effects, most doctors will start a migraine patient with a low dose of an anticonvulsant drug—typically 25 mg per day—and gradually increase it until an effective dose is reached.

Anticonvulsant Target Dose
Depakote 400 to 1000 mg per day
Topamax 100 to 200 mg per day
Qudexy XR 100 mg per day
Trekendi XR 100 mg per day

As with the FDA-approved beta-blockers, these two anticonvulsants are listed as Level A medications for preventing migraines.

Calcitonin Gene-Related Peptide (CGRP) Inhibitors

These relatively new medications differ from beta-blockers and anticonvulsants in a significant way: They were developed solely for preventing chronic and episodic migraine headaches (with or without aura).

CGBP inhibitors are in a class of biologic drugs called monoclonal antibodies, which means that rather than being synthesized from chemicals, they are produced by altering the DNA inside of living cells. They work by targeting a protein in the brain and nervous system that plays a role in the progression and pain of migraines.

Three CGRP inhibitors have gained FDA approval for migraine prophylaxis. All are administered by subcutaneous injection with a thin needle into a thigh or abdomen, a skill most people are able to master with instruction. Note that these medications were developed after the AHS/AAN guidelines were published, and so they do not have an effectiveness rating.

  • Aimovig (erenumab-aooe)
  • Ajovy (fremanezumab-vfrm)
  • Emgality (galcanezumab-gnlm)
CRBG Inhibitor Dosage
Aimovig 1 or 2 shots (70 mg) per month
Ajovy 1 or 2 shots (225 mg) per month
Emgality 2 shots (120 mg each) the first month; 1 shot per month thereafter

Drugs Approved for Preventing Chronic Migraines

In addition to being approved for preventing episodic migraine headaches, each of the CGRP inhibitors also is approved for preventing chronic (or transformed) migraine—when at least 15 migraine attacks occur per month for at least three months.

The only other drug approved by the FDA for chronic migraine prophylaxis is Botulinum toxin A—what most people know as Botox.

Botox (also called Onabot) is a diluted form of a bacterial toxin that paralyzes muscles. Originally injected into the face to relax muscles and temporarily smooth out wrinkles, Botox was found to reduce the frequency of migraine headaches in people prone to them who used the drug for cosmetic purposes.

This prompted researchers to study Botox injections as a preventive treatment for migraines. It was found to be effective only for chronic migraines, a use the FDA ultimately approved.

Typical Botox Protocol

Botox treatment for migraine prevention usually involves 31 separate injections into seven key muscles of the face and neck every 12 weeks. It can take up to six months to get the full therapeutic effects.

Is It Always Better to Choose an FDA-Approved Drug?

Choosing and FDA-approved drug for migraine prevention (or any other reason) ensures that, according to the FDA's website, "the agency has determined that the benefits of the product outweigh the known risks for the intended use." Approval is granted after review of testing (lab, animal, and human) done by drug manufacturers (the FDA does not test drugs itself).

As such, opting for an FDA-approved migraine drug is always preferred. That said, there are times when your doctor may recommend that a drug be used off-label, meaning that it is not approved by the FDA for the use he intends to prescribe it (though it is approved for other reasons). This is often done when FDA-approved choices have proven to be ineffective and when there is at least some evidence that the medication is helpful.

Using a drug off-label may be effective and perfectly safe for you. But given that the FDA cannot verify that its pros outweigh its cons for the purpose for which you're using it, there is more reason to use caution.

A Word From Verywell

Prophylaxis is a vital part of migraine management. The FDA-approved medications aren't the only drugs that may be prescribed to prevent headaches or to at least reduce the number of headaches the occur per month, but they obviously are the ones that have been studied the most and found to be effective. If you aren't able to tolerate any of them or if none work for you, there are plenty of other options to discuss with your doctor.

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