FDA approves first drug to prevent migraines

The Food and Drug Administration approved on Thursday the first drug designed to prevent migraines.

A once-monthly, self-injection, Aimovig is the first in a new class of long-acting drugs that is FDA-approved to specifically prevent migraines. It works by blocking the activity of a specific molecule, calcitonin gene-related peptide, that is involved in migraine attacks, the FDA announced in a press release.

The drug, expected to be made available to patients within a week, is made by Amgen and Novartis. Without insurance it will cost $575 for once monthly injections or $6,900 per year, Novartis said in a press release.

Migraines are more than just headaches. They cause severe throbbing and pulsating pain on one side of the head. They are accompanied by nausea, vomiting and extreme sensitivity to light and sound. Attacks cause significant pain for hours to days and can be so severe that they become debilitating.

RELATED: Foods that exacerbate headaches

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Foods that exacerbate headaches
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Foods that exacerbate headaches

Diet soda

If you’re plagued with headaches, look at your diet soda intake. While the Dietary Guidelines Advisory Committee (DGAC) recently gave the go-ahead to consume aspartame in moderation, the FDA has received thousands of consumer complaints about aspartame due mostly to symptoms such as dizziness, memory loss, and headaches. The 2015 Scientific Report of the DGAC says, “If individuals choose to drink beverages that are sweetened with aspartame, they should stay below the aspartame Acceptable Daily Intake (ADI) of no more than 50 mg/day." (A 12-ounce diet beverage contains approximately 180 mg of aspartame.)

Ripe bananas and avocados

You’ve heard nutrition experts praise bananas and avocados because of their many health benefits, but ripe bananas and avocados are also high in tyramine. “Certain foods that are high in tyramine can cause migraines,” says Jennifer Kriegler, MD, of the Center for Neurological Restoration at the Cleveland Clinic. Even if you’re not prone to migraines, high tyramine levels can still cause headaches. Tyramine is an amino acid that most people can digest without issue. However, if a person has the enzyme monoamine oxidase (MAO) deficiency or if the person is taking certain antidepressants it can interfere with the breakdown process. “Ripe bananas and ripe avocados can be potent headache triggers because they contain high amounts of tyramine,” says Kriegler. Make sure you know these sneaky signs you're about to have a migraine.

Bread 

Gluten in foods like wheat, crackers, pasta, and seasoning mixes may cause digestion woes (not to mention celiac disease), but for some, headaches can also be a symptom of gluten sensitivity. Gluten is in food products made with wheat, wheat germ, rye, graham flour, crackers, pasta, and seasoning mixes, to name a few. But, according to Michael Gregor, MD, of Nutritionfacts.org, celiac disease should be ruled out before going on a gluten-free diet.

Ice cream 

The first few slurps of a chocolate shake are heaven, but then suddenly your tasty adventure comes to a screeching halt when you encounter an “ice cream headache.” Luckily, the crushing pain usually subsides a minute or two later. The mystery is: Why does this come on so hard and fast and then disappear? Introducing a very cold food like ice cream or an ice drink to the throat may cause a reflex constriction of blood vessels around your head. When you think about the last “ice cream headache” you had, it does resemble a vice grip on your head!

Cocktail party foods

Aged cheeses, nuts, olives, and pickled products like baby corn and pickles are the standard appetizers for many cocktail parties. However, these little bites are high in tyramine. The National Headache Foundation suggests limiting intake of tyramine to help control headaches. Tyramine levels can increase in foods that are aged, fermented, or stored for long periods of time. Learn more about the different types of headaches and how to get rid of them.

The #11 special at your favorite Chinese restaurant

Monosodium glutamate (MSG) is a flavor enhancer used to prepare many foods but the MSG content in foods like our favorite take-out may be higher enough to trigger a headache. To be fair, MSG isn’t just in Chinese foods. MSG can be found in everything from frozen foods, to canned soups, and snacks foods. The higher the MSG content, the more risky it could be for a headache trigger. Patients with migraine may have an exacerbation of headaches after ingesting MSG, because of its effects on cranial blood vessels.

Gum

Chewing a piece of minty gum for a few minutes after a garlic-laden lunch probably won’t trigger a headache, but if you’re a frequent chewer, you may want to switch out gum for a mint. Excessive chewing gives your jaws quite the workout. In a recent small study, 19 of the 30 gum chewing teens observed found relief from chronic headaches when they stopped chewing gum. Even though the study focused on teens, the same holds true for adults.

Cheese

The aging process for cheese makes it taste better but the longer it ages, the more tyramine it contains. Blue cheese, brie, cheddar, feta, mozzarella, parmesan, and Swiss cheese have a high tyramine content, which can trigger migraine headaches.

Red wine

Pouring a glass of wine is often something we do to unwind at the end of the day, but for some, it could give you a bigger headache than the looming deadline you left at the office. Red wine, beer, and other alcohols contain high levels of tyramine. “The reason for this is that tyramine is an amino acid that our body usually has no problem breaking down with the enzyme monoamine oxidase (MAO). Unfortunately, certain circumstances can inhibit the breakdown of this amino acid, such as when a person takes certain antidepressants or if the person has an MAO deficiency,” says Tory Tedrow, a registered dietitian for the app MigraineChecked. Look out for these 16 signs your headache is a sign of something much worse.

Cold cuts

Your beloved turkey sandwiches could be giving you a post-lunch headache. The high levels of tyramine and food additives like nitrates or nitrites can increase blood flow to the brain in some people. A nitrate-induced headache is no picnic because they usually cause pain on both sides on the head.

Salt 

We took the salt shaker off the table and we’re not sprinkling added salt on our food but we still could be fooling ourselves. Sodium is sneaky. “A large amount of sodium in the American diet comes from some processed, prepackaged, and restaurant foods. Some people may not realize that cheese, canned soups and vegetables, frozen entrees, boxed macaroni and cheese contain sodium,” says Leigh Tracy, a registered dietitian at The Center for Endocrinology at Mercy Medical Center in Baltimore. “A study last year suggested a link between high sodium intake and the occurrence of headaches; however, it is unclear exactly what happens in the body and more research is needed,” says Tracy.

Chocolate

Sorry, but yes: This delicious dose of happiness could cause a headache. Chocolate contains a few substances that may be to blame: caffeine, tyramine, and phenylethylamine (a neurotransmitter that has stimulating effects). While this combination may make some people swoon, in others, it is a formula for a headache. Here are 13 more surprising things that could be triggering your headaches.

No food

Speaking of foods, you should eat something! When you skip meals your glucose levels drop, a buildup of muscle tension occurs, levels of serotonin and norepinephrine are out of whack, and a rebound dilatation of the blood vessels ensues, all adding to a whopper of a headache.

How to deal with headache food triggers

The National Headache Foundation recommends keeping a food log of the foods you have eaten before a headache. Note the time you ate and when the symptoms occurred. Identify the trigger foods and see if eliminating them from your diet reduces or eliminates your headaches. Don't miss these 34 easy ways to reduce your risk of headaches.

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Migraine sufferers can sometimes predict the onset of an attack because it is preceded by an aura. Approximately one-third of migraine sufferers experience auras, the FDA reported. These are visual disturbances that appear as flashing lights, zig-zag lines or temporary loss of vision.

"Aimovig provides patients with a novel option for reducing the number of days with migraine," said Dr. Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We need new treatments for this painful and often debilitating condition."

Aimovig's effectiveness was studied in several clinical trials. The first tested the drug on 955 patients with a history of episodic migraines. Researchers compared the injection to placebo and found that over the course of six months patients treated with Aimovig had one to two fewer monthly migraine days on average than those treated with placebo.

In the second trial, researchers studied 577 patients with episodic migraines over the course of three months. Compared to placebo, those treated with the Aimovig injection had one fewer migraine day per month on average. The third study examined 667 patients with a history of chronic migraines over the course of three months. Compared to placebo, patients treated with the injection experienced 2.5 fewer migraine days per month.

Novartis reported that in a Phase 3b study, patients with episodic migraines who have failed two to four prior treatments had almost three-fold higher odds of having their migraine days cut in half when taking Aimovig compared to placebo.

According to the FDA and Novartis, the most common side effects participants experienced were constipation and injection site reactions.

Current prevention treatments for migraines include drugs originally developed for other conditions, such as epilepsy. However, many of these drugs come with serious side effects. The wrinkle reducer Botox has also been approved as a migraine treatment.

More than 10 percent of people worldwide suffer from migraines, and they are three times more common in women than in men. Migraine attacks can be triggered by a variety of factors, including certain types or lack of food, lack of sleep, the weather, hormonal changes, bright lights and stress.

Copyright 2017 U.S. News & World Report

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