Botox – More Than Just A Pretty Face?

October 18, 2010

One of the things about progress in medicine is the sheer adaptability of a treatment or drug when faced with adverse publicity. Botox has certainly had plenty of the latter, and now I read that FDA approved it for March as treatment for flexor muscle spasm of the elbow, wrist, and fingers in adult patients and now expanded that to include the prevention of migraine headaches in adults.

According to Russell Katz, MD, director of the neurology products division in the FDA’s Center for Drug Evaluation and Research, “Chronic migraine is one of the most disabling forms of headache. Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”

Well yes, that is certainly true and Botox prescribed for migraines is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Personally I wonder how it helps as this is a treatment that actually paralyses the muscles of the forehead we must have an effect on blood flow and I would have thought on migraines that happily I am not a doctor and am therefore allowed to speculate just how beneficial this might be.

In case you were wondering if you could get your wrinkles treated and your headaches at the same time please note that the FDA say that it “has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache.”

This research is based yet again on a tiny sample. It took place in February with just 18 participants who were patients with imploding and ocular headaches who were having Botox to treat their wrinkles and they did see a reduction in their migraines as well. Though again I have to wonder whether they had fewer migraines because they were smiling a lot more at their new and improved appearance, and in any event once you have Botox you are unable to frown and we know that smiling more often elevate your mood and perhaps give you less to have a headache about?

Interestingly the most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache — really?

Anyone considering Botox — whether for cosmetic or medical reasons — needs to be aware that if the botulinum toxin spreads to other areas of the body than the reactions can include swallowing and breathing difficulties and these can be life-threatening.

What is more interesting fact for me is that Allergan (who make Botox) also have been making headlines over marketing issues related to it. The company announced last month that it would pay $375 million in fines after pleading guilty to a charge of misbranding related to off-label use of botulinum toxin and a further $225 million to settle civil claims brought by the Department of Justice.

The misbranding charge alleged that, during the period from 2000 to 2005, labelling for the drug did not contain complete directions for intended use, which included off-label uses for headache, pain, spasticity, and juvenile cerebral palsy — none of which they are currently recommending it for I believe.

Oh, and in case you wanted to know about their most recent developments I’m sure you will be pleased to hear that Allergan is now conducting phase III trials using Botox with patients who have neurogenic and idiopathic overactive bladder. I really don’t want to think about what the effect of a muscle freezing agent is going to do in those cases.


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