Compared with placebo treatment, treatment with Topamax was associated with an 8 percent greater reduction in the percentage of heavy drinking days during the trial, the researchers reported.
Researcher Bankole Johnson, MD, tells WebMD that alcoholics in the trial who took Topamax went from the equivalent of drinking a bottle and a half of wine a day to about 3 1/2 glasses of wine.
“I think that is a big difference,” he says. “Most people can manage that amount of alcohol without getting into too much trouble.”
The researchers reported that Topamax users had a greater rate of achieving 28 or more days of continuous nonheavy drinking during the study and 28 days of continuous abstinence.
The manufacturer has also been accused of promoting off-label use:
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.
I’m not surprised. I’ve wondered what arrangement led to the prominent placement of topiramate in the HBO series. It was practically an infomercial and led the lay people I know to grossly overestimate the effectiveness of the drug.
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