FDA approves Botox® as treatment for chronic migraines (WNDU.COM)


Source: WNDU.COM
By Maureen McFadden

After more than a decade of off-label use, the Food and Drug Administration (FDA) has finally approved Botox® as a treatment for chronic migraines.

Although some use the word very loosely, migraines are far more severe than a typical headache and cost the United States $20 billion each year in lost wages, disability payments and health care bills.

Migraine pain can be so severe, for some, it can become a driving hazard. For Irene Devine, driving, rain and lights were all it took to trigger her migraines.

"I would be vomiting," said Devine. "I would be really debilitated."

For others like Sharon Roth, the persistent pain never seemed to end, lasting nearly 20 hours each day. Her migraines could be triggered by anything, even scents and stress.

"It feels like somebody has taken a dagger and a knife and just stuck it in the side of my head," said Roth. "My migraine controlled me. I couldn't control my migraine."

Many patients suffering from chronic migraines have tried countless medications and even acupuncture. Some turned to Botox®, a purified toxin and muscle relaxer.

"There are certain messengers that are expressed in migraine headaches. Botox® onabotulinumtoxinA actually inhibits those messengers blocks those messengers," said doctor Robert Duarte, director of Long Island Jewish Hospital's Pain and Headache Treatment Center. "Generally you are putting about 30 to 31 injections, needles into their forehead, temple and back of the neck."

Relief can start in about six days and last up to three months. Duarte warns that minor neck pain is a side effect.

For many chronic migraine sufferers, doctors believe it may actually be a safer option as many often over-use pain medication.

Since their Botox® injections, both Devine and Roth still have some multi-migraine days. However, both can tell there is a difference.

"We were selling fragrances and I did it," said Roth. "I was able to stand one of the triggers."

"I feel very confident that I can get myself around and that's a very good feeling," said Devine.

To qualify for the Botox® migraine treatment, patients must have had migraines more than 15 days per month and for more than four hours per day.

Patients must also have had those symptoms for more than three months and have tried other medications.

The entire treatment can cost between $800 and $1,600 but since the FDA approval, the injections have become easier for patients to pay for as the treatment is covered by insurance.

Research Summary:
Botox® For Migraines: Erasing Migraines, Not Miracles
Background: Migraines are more severe than a typical headache and are often accompanied by symptoms such as nausea, vomiting, or sensitivity to light. Migraines may be caused by changes in the brainstem and its interactions with the trigeminal nerve, a major pain pathway. Imbalances in brain chemicals, including serotonin, which helps regulate pain in your nervous system, also may be involved. In the U.S., more than 30 million people suffer from a migraine, which means there is a migraine sufferer in 25% of all U.S. households. (Source: Mayo Clinic, migraine.com)

Smoothing Out Migraines: Botox® has been famous for smoothing out wrinkles but has been approved by the FDA to treat chronic migraine headaches in adults. The FDA says that Botox® injections have been shown to be effective in preventing the debilitating headaches, intense pulsing, and throbbing pain of migraines. Injections of Botox® typically act to temporarily blunt nerve signals to certain muscles or glands.

Botox® to treat chronic migraines is given at intervals of about 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. The FDA's approval for use of Botox® to fight migraines was based on the results of two studies involving 1,384 adults in North America and Europe. (Source: WebMD)

Finally, Some Relief: Relief from Botox® treatment can come as early as 48 hours after injection, and last for up to four months. Side effects such as soreness of neck and numbness are temporary The FDA has placed a "boxed warning" on this drug reporting that its effects may spread from the area of injection to other areas of the body. Other side effects can include swallowing and breathing products but the FDA says it knows of no confirmed cases of the spread of the toxin effect when used in recommended dosages. (Source: WebMD)

Not For Everyone: Doctor's do say that Botox® is not a good option for everyone who suffers from chronic migraines. Candidates for this treatment must have migraines lasting more than 15 days per month for more than four hours a day.

For more information, contact:
*Dr. Robert Duarte
(516) 719-7246