Botox Approved For Chronic Migraine
Botox — It Isn’t Just for Wrinkles Any More!
Since its introduction and approval for use in eye disorders by FDA in the late 1980’s, new medical uses for Botox (onabotulinumtoxin A) have continued to be explored. Many of these new uses came as a result of physicians and patients noticing beneficial effects of Botox for other conditions other than the one for which they were being treated. For example, Botox Cosmetic was introduced as a result of ophthalmologists observing that their patients with eye disorders had fewer wrinkles. Now Botox has gained FDA approval for the prevention of migraine headache because certain people who used Botox Cosmetic for wrinkles noticed improvement in their migraine headache symptoms.
Approval at a Cost
Earlier this year, Allergan settled a $600 million dollar case with the U.S. Department of Justice for marketing Botox for migraine and other non-approved uses between the years 2000-2005. The Allergan sales force participated in a number of activities targeted at off-label use of Botox including directing physician workshops and dinners and operating the Botox Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses. Under the Food, Drug and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a biological product. After the FDA approves the product as safe and effective for a specified use, such as migraine headache, any promotion by the manufacturer for other uses — known as “off-label” uses — renders the product misbranded.
Studies Show Limited Benefit
Allergan gained its FDA approval for the use of Botox for migraine prevention after two large studies were conducted which included more than 1300 headache sufferers with chronic symptoms (people who experience a migraine-like headache that lasts for at least 15 days per month and at least 4 hours per day). People experienced moderate improvement in the number of days per month they experienced a headache as well as the duration of each headache. The migraine treatment regimen, which involves 31 separate muscle injections in 7 regions of the head and neck areas on both the right and left sides, is repeated every 12 weeks. The most common side effects reported during the studies included headache, migraine, facial loss of movement, eyelid drooping, lung inflammation, neck pain, muscle stiffness and weakness, muscle pain and spasms, pain at the injection site and high blood pressure.
Botox Adds to Available Options
While current common non-traditional treatments for migraine include antidepressants, blood-pressure medications and medications that target the brain chemical serotonin, the approval of Botox for migraine represents an alternative for people who find that standard treatment options offer them no relief. Although it is not exactly known how frequently Botox may have already been used for chronic headaches and migraines prior to gaining official FDA approval, insurance companies who would previously not cover unapproved Botox for this indication may now be more inclined to do so. The number of headache specialists who offer Botox as a treatment option may increase as well. Patients who are contemplating the use Botox for prevention of chronic migraine should be aware of the benefits and risks of all available treatments and select the one that is right for them after discussion with and providing a thorough medical history to their physician.
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