FDA approves Botox to treat chronic migraines

SANTA ANA, Calif. — The Food and Drug Administration has approved Botox as a treatment for chronic migraines.

Irvine, Calif.-based Allergan, which makes Botox, announced Friday that it had received a letter from the FDA granting the approval for the use of Botox as a method of preventing migraines in patients who have the headaches an average of 15 or more days per month and lasting four hours a day or more.

An estimated 3.2 million Americans are affected by chronic migraines, the company said.

In a typical treatment session, a headache specialist such as a neurologist injects a total of 155 units of Botox into seven sites in the head and neck, an Allergan spokeswoman said.

For doctors, the price for Botox will remain $525 for a 100-unit vial, according to the Wall Street Journal.

In many cosmetic Botox sessions, doctors inject a total of 100 units of the diluted form of botulinum toxin into the forehead and around the eyes. But the FDA has only approved cosmetic injections of 20 units to treat wrinkles between the eyebrows.

The safety and effectiveness of Botox has not been established for the treatment of episodic migraine, Allergan said.

In July, British regulators approved Botox for migraine sufferers.

Allergan has been running clinical trials of Botox as a treatment for migraines since 2004.

In one trial, patients treated with Botox had 7.8 fewer days per month of headaches, compared to 6.4 fewer days with a placebo, BusinessWeek reported. In another trial, patients getting Botox had 9 fewer days of headaches, compared with 6.7 days fewer for an inactive injection.

In the United States, because Botox is approved for other uses, doctors such as Dr. Susan Hutchinson at the Orange County Migraine and Headache Center in Irvine have already prescribed it routinely as a treatment for migraine sufferers. Observers predict that FDA approval will expand the number of doctors willing to offer Botox as a migraine treatment.

Botox sales total $1.3 billion a year, and analysts have said that FDA approval of Botox as a migraine treatment could add $1 billion to that total.

In a news release, the FDA said the Botox injections will typically be timed every three months, with the aim of dulling future headaches.

Clinical studies have not shown that Botox works as a treatment for other types of headaches or for migraines that occur 14 days or fewer per month, the FDA said.

In previous tests, the most common side effects for migraine patients treated with Botox were neck pain and headache.

The FDA noted the potential risks of Botox:

“OnabotulinumtoxinA, marketed as Botox and Botox Cosmetic, has a boxed warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening.

“There has not been a confirmed serious case of spread of toxin effect when Botox has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm or strabismus, or when Botox Cosmetic has been used at the recommended dose to improve frown lines.”

Talk to us

More in Local News

Zachary Robbins
Marysville superintendent could start a month early

A June start means Zachary Robbins could weigh in on a $13.5 million budget shortfall and a parental consent policy for clubs.

Arlington
Driver dies after rollover crash at Smokey Point

The deceased man, 25, reportedly sped off from police before crashing into a nearby utility pole. A woman, 19, was injured.

Epic Ford on the corner of 52nd Street and Evergreen Way in Everett is closed. The dealership has been in business for more than 50 years. (Janice Podsada / The Herald)
After 50 years, Everett’s Epic Ford dealership closes shop

It opened in 1971, when gas guzzling muscle cars like the Ford Mustang still ruled the road.

Nuno Taborda
Former Rolls Royce executive to lead Everett aerospace firm

magniX, which builds electric aircraft motors, has hired Nuno Taborda as its next CEO.

Marysville
Smokey Point Boulevard stretch closed for crash investigation

The road was closed between 136th Street NE and 152nd Street NE after a possibly fatal collision.

The Mountain Loop Highway between Darrington and Granite Falls remains closed beyond Barlow Pass. (Snohomish County)
Oops, Mountain Loop Highway only partly open

A miscommunication led Snohomish County to misstate how much of the road is open.

Monroe High School with (inset) a Facebook video screenshot from Nov. 10, 2021, which showed a white student repeatedly using racial slurs in a confrontation with a Black student.
‘It makes me angry’: Black students in Monroe report persistent racism

“Please help stop this racism,” a first-grade student told the Monroe school board Monday. Other kids reported racist slurs.

Destiny Conner, 13, takes tags off of clothing at the new Volunteers for America storefront on Monday, May 16, 2022 in Sultan, Washington. (Olivia Vanni / The Herald)
At Sultan’s only thrift store, teens learn teamwork, job skills

Teens with the Sky Valley Youth Coalition “stepped up and created the store” on Main Street.

Joshua Freed
Ex-Bothell mayor accused of misleading real estate investors

One Snohomish couple sued Joshua Freed after losing a $300,000 investment in a development project.

Most Read