The Food and Drug Administration has had its hands full with several recent cases of removing once approved drugs off of the market due to serious health risks. Now, the FDA has approved Botox injections for the prevention of chronic migraines in adults.
OnabotulinumtoxinA injection (Botox) is used to relieve the symptoms of cervical dystonia, which is the uncontrollable tightening of the neck muscles that may cause neck pain and abnormal head positions and strabismus, an eye muscle problem that causes the eyes to turn inward or outward. Cosmetically, it is used to temporarily smooth frown lines and wrinkles between the eyebrows.
It is in a class of medications called neurotoxins. In a press release, the Food and Drug Administration recommended that Botox may be injected every three months around the head and neck to dull future headache symptoms. The drug hasn’t been shown to work for migraines that occur 14 days a month or less or for other forms of headache.
Migraines are described as a throbbing pain that occurs in one area of the head, and may also be accompanied by nausea, vomiting and sensitivity to light and sound. Chronic migraines are defined as those that happen for 15 days or more a month for more than four hours per day. The drug, which is made by Allergan Inc., of Irvine, Calif., was approved recently in Britain for the same purpose.
The new approval was based on results obtained from privately funded studies submitted to the FDA with 1,384 adults from 122 sites in Europe and North America. Their findings suggested that after six months, patients who got the drug experienced 7.8 and 9.2 fewer days of migraine than they had before the studies started. It was also reported that the most common adverse side effects reported by study subjects were neck pain and headache. The drug may also cause life-threatening difficulties swallowing and breathing.
Last year, Allergan reported Botox drug sales of approximately $1.3 billion. Earlier this summer, the company settled a Justice Department investigation into its marketing practices related to uses of Botox by paying $375 million and pleading guilty to a misdemeanor misbranding charge. –torrance stephens, ph.d.
