Seizure Drug May Treat Alcoholism
Oct. 9, 2007 -- The seizure and migrainemedicationTopamax shows promise for treating alcohol dependence, a study shows. But use of the drug for this purpose is not without controversy.
Alcohol-dependent patients in the University of Virginia study who took Topamax for three and a half months averaged fewer heavy drinking days overall, fewer drinks per day, and more days of continuous abstinence from drinking than patients given placebo treatments.
The study was paid for by Topamax manufacturer Ortho-McNeil Neurologics, and it appears in the Oct. 10 issue of TheJournal of the American Medical Association.
A spokeswoman for Ortho-McNeil tells WebMD that the company will not be pursuing FDA approval for the drug as a treatment for alcohol dependence.
But in a letter to the FDA, the consumer interest group Public Citizen accused the company of illegally promoting use of the drug for this purpose.
While doctors can legally prescribe FDA-approved drugs for nonapproved conditions, it is illegal for the companies that market the drugs to promote these so-called "off label" uses.
The Public Citizen complaint involved a question-and-answer sheet distributed to the media before publication of the study, which specifically discussed the drug's potential "off label" use for alcohol dependence.
Kara Russell of Ortho-McNeill tells WebMD that the company knew nothing about the question-and-answer sheet until the Public Citizen letter became public.
"Ortho-McNeil Neurologics does not support any reference to off label use of its products and only promotes the use of Topamax in the approved indication of migraine and epilepsy treatment," Russell says.
(What approaches have you tried to quit drinking? What has worked best? Discuss it with others on WebMD's Addiction and Substance Abuse: Support Group board.)
The study included 371 men and women with alcohol dependence. The men drank 35 or more standard alcoholic drinks per week prior to enrollment; the women had 28 or more drinks. Participants' ages ranged from 18 to 65 with an average of around 47.
A standard alcoholic drink was defined as one containing 0.5 ounces of alcohol, which is found in a 10-ounce regular beer, a 4-ounce glass of wine, or 1 ounce of 100-proof liquor.
Alcohol-dependent patients in the University of Virginia study who took Topamax for three and a half months averaged fewer heavy drinking days overall, fewer drinks per day, and more days of continuous abstinence from drinking than patients given placebo treatments.
The study was paid for by Topamax manufacturer Ortho-McNeil Neurologics, and it appears in the Oct. 10 issue of TheJournal of the American Medical Association.
A spokeswoman for Ortho-McNeil tells WebMD that the company will not be pursuing FDA approval for the drug as a treatment for alcohol dependence.
But in a letter to the FDA, the consumer interest group Public Citizen accused the company of illegally promoting use of the drug for this purpose.
While doctors can legally prescribe FDA-approved drugs for nonapproved conditions, it is illegal for the companies that market the drugs to promote these so-called "off label" uses.
The Public Citizen complaint involved a question-and-answer sheet distributed to the media before publication of the study, which specifically discussed the drug's potential "off label" use for alcohol dependence.
Kara Russell of Ortho-McNeill tells WebMD that the company knew nothing about the question-and-answer sheet until the Public Citizen letter became public.
"Ortho-McNeil Neurologics does not support any reference to off label use of its products and only promotes the use of Topamax in the approved indication of migraine and epilepsy treatment," Russell says.
(What approaches have you tried to quit drinking? What has worked best? Discuss it with others on WebMD's Addiction and Substance Abuse: Support Group board.)
Fewer Drinks and Drinking Days
The study included 371 men and women with alcohol dependence. The men drank 35 or more standard alcoholic drinks per week prior to enrollment; the women had 28 or more drinks. Participants' ages ranged from 18 to 65 with an average of around 47.
A standard alcoholic drink was defined as one containing 0.5 ounces of alcohol, which is found in a 10-ounce regular beer, a 4-ounce glass of wine, or 1 ounce of 100-proof liquor.