Clinical trials to determine the efficacy of Botox (botulinum toxin type A) for Migraine prevention have been underway for several years. During this time, some doctors have used Botox off-label for their patients. Let's take a look at where things stand now, in September of 2010.
A bit of background: Off-label prescribing or usage of medications is very common. "Off-label" simply means using a medication for a purpose other than those for which the FDA has specifically approved it. Once a medication is approved by the FDA for human use, it's both legal and legitimate for doctors to prescribe it for other conditions when they believe it will be helpful. Migraine preventive medications are a perfect example of off-label prescribing. Of the more than 100 medications in use today, none of them were originally developed for MIgraine treatment. They were all developed for other conditions, then found to work as preventives for some Migraineurs. Four of them were put through the additional clinical trials to win formal FDA approval for Migraine prevention:
- propranolol, a beta blocker, brand name Inderal
- timolol, a beta blocker, brand name Blocadren
- divalproex sodium, a neuronal stabilizing agent (anticonvulsant), brand name Depakote
- topiramate, a neuronal stabilizing agent (anticonvulsant), brand name Topamax
What's NOT permitted:
It's legal to prescribe medications off-label, BUT it's not legal for pharmaceutical companies to promote or advertise a medication for any purpose for which it's not FDA approved. That means that Allergan, the manufacturer of Botox, may promote and advertise it for the purposes for which it is already approved - cosmetic purposes, blepharospasm, cervical dystonia, hyperhidrosis, strabismus, and upper limb spasticity. Promoting it for off-label use constitutes what the FDA calls "misbranding," and it's illegal.
Recently, Allergan was in the news when they agreed to pleas guilty and pay a $600 million fine to resolve allegations that they had promoted Botox off-label.
A point that needs to be understood about this is that the issue was NOT about doctors using Botox off=label. It was entirely about allegations that Allergan had promoted it for purposes other than those for which it was FDA approved. So, it has nothing to do with the medication itself, but about marketing and promotion practices.
Good news of progress:
Botox was recently approved in the UK for treating Migraine. In the U.S., the FDA is currently reviewing clinical trial data about Botox and Allergan's application for FDA approval of Botox for Migraine treatment. Many Migraineurs are hopeful that FDA approval will come soon. I've heard from many Migraineurs who would like to have the option for trying Botox for MIgraine prevention, but their insurance companies decline payment, saying that the treatment is "experimental" or "investigational."
If you've been wondering about Botox, you might be interested in reading Allergan's information about Botox History and Development, which includes a time line of when Botox was approved for various uses.
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© Teri Robert, 2010
Last updated September 13, 2010