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FDA Approves New Treatment That Prevents Cluster Headaches

Image result for FDA Approves New Treatment That Prevents Cluster HeadachesPITTSBURGH (KDKA) — Cluster headaches can be just as bad as migraines and just as difficult to treat.

But the Food and Drug Administration has just approved the first drug to not only treat, but also reduce the frequency of cluster headache attacks when they occur.

“Like a hot poker into my eye. I would always get them in my right eye.” Michelle Bartley’s headaches would come every other week, and last five to 10 days. Every 15 minutes, another wave. “Like getting brain freeze, but it would be like on a pain scale of ten. I wouldn’t be able to sleep. They would wake me up in the middle of the night. I would bang my head against the wall. I would push into my head.”

Instead of going somewhere dark and quiet, she would pace.

“My nose would run, my eye would droop, my eye would water,” she said.

Thirty years of these headaches. First she was diagnosed with allergies, then migraine, then two years ago, cluster headaches.

These are less prevalent and different from migraines.

Migraines tend to start on one side of the head, but can move. They’re more common in women.

With cluster headaches, the pain involves the eye.

“It feels like the eye is going to jump out. It’s really severe throbbing pain,” says Allegheny Health Network headache specialist Dr. Dolores Santamaria.

Along with the pain, people can have redness and watering of the eye, a runny nose, a small pupil, a drooped eyelid, and flushed skin on the same side. The episodes last 15 minutes to 3 hours and occur repeatedly during a cluster, which can last a week…or months. These headaches are more common in men

The usual treatments include oxygen or medications at the time of an attack.

“I would be on this oxygen for half an hour, and sometimes it would work, and sometimes it wouldn’t,” says Michelle. “A lot of it was hit or miss with all of the medication that you take.”

There has never been anything to prevent clusters… until now.

The FDA has approved a medicine — called Emgality — not only as a treatment for cluster headaches, but also prevention.

Initially it came on the market in 2018 for migraine prevention. but in a placebo-controlled study of more than 100 people with cluster, 70 percent had their headache frequency cut in half.

There are three injections at 100 milligrams each. “It’s three injections, 300 milligrams, at three different sites at the onset of the attack,” Dr. Santamaria explains. “Then it’s a single shot once a month until the cluster is over.”

This monthly injection blocks a fragment of protein circulating in the bloodstream. this blocking interferes with a hormone associated with episodic cluster headache.

“We don’t know exactly where the pathways to activate this terrible pain,” Dr. Santamaria admits.

“What are the long term effects of this medication? And I still don’t know that,” Michelle worries.

In the study, the only side effect was injection site irritation, and some people could be allergic to it.

“About the day after I inject, I get a little, a little cranky. My husband says he can’t tell the difference,” says Michelle.

And it’s pricey.

“My insurance would not cover it. And the shots are about $2000 a month.”

But the drug maker offers some assistance.

“They gave me the no pay card, for it. And so they’ve paid 100% of it each month.”

Because of the new medication, Dr. Santamaria expects more people with cluster headache will come forward. “Wwe have a treatment to offer them. so they’re going to be back and say, I’ve been diagnosed with cluster, and now I have an attack. Do you have something for me? Yes, I do.”

Michelle started the medicine in October and she hasn’t had a headache since. “It’s taken a complete 180.”

She no longer carries her rescue medicine everywhere she goes. “I keep waiting for like this worst headache to come back, because it’s been gone so long. What she’s told me is the longer I keep this medication in my system, the longer the headaches will stay away. As time keeps going on, and I’m not getting one, I’m starting to relax a little bit.”

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