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 says in a statement.
The FDA says it’s important that patients who suffer chronic migraines discuss with their doctors whether Botox is appropriate for them.
Allergan Inc., the maker of Botox, says in a statement that the FDA’s approval applies to people with chronic migraine, which it defines as a “distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer.”
The company says that when treating chronic migraine, qualified medical specialists administer 31 Botox injections into seven specific head and neck sites.
It says that Botox, when injected at labeled doses in recommended areas, is expected to produce results lasting up to three months depending on the individual patient.
“Chronic migraine is a debilitating but under-recognized neurological condition,” Scott Whitcup, MD, Allergan’s chief scientific officer, says in the company’s announcement. “Oftentimes, chronic migraine patients mistakenly self-diagnose their symptoms as headaches or infrequent migraine and treat them with drugs that provide rapid, but temporary, relief rather than seeking an evaluation, diagnosis and treatment from a qualified headache specialist.”