Letter to the FDA urging action against a campaign promoting the unapproved use of Topamax for treating alcoholics (HRG Publication #1825) October 9, 2007
Andrew von Eschenbach, MD, Commissioner
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. von Eschenbach:
I urge you to immediately stop the illegal and dangerous promotional campaign by Ortho-McNeil Janssen-funded researchers for the unapproved use of Topamax (topiramate) for treating alcoholics (the drug is only approved for treating seizure disorders and migraines).
In a study to be published in tomorrow’s Journal of the American Medical Association, funded entirely by the company, researchers from the company and from the University of Virginia find only a modest improvement in the percentage of days of heavy drinking in people using Topamax compared with people using a placebo. Both groups also got a weekly 15 minute intervention by a trained nurse to promote compliance.
But accompanying the study, in an embargoed press kit distributed by the University of Virginia on behalf of the researchers, is a question and answer sheet asking “Can my doctor prescribe me topiramate for alcohol dependence?” The answer is, essentially, yes: “Since topiramate is currently FDA-approved for seizures and migraines, it is available to your doctor to prescribe it to you off-label.” This clearly violates the prohibition on off-label promotion, as patients are being explicitly urged/promoted to ask their doctor for topiramate to treat their serious alcohol addiction.
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