On October 9, 2007, Sidney M. Wolfe, MD, the director of the Health Research Group of Public Citizen, sent a letter to the commissioner of the United States Food and Drug Administration (FDA) urging action against a specific promotion of Ortho-McNeil’s Topamax. Topamax is manufactured by Ortho-McNeil and approved for treatment of seizure disorders and migraines.

The letter, which was made public by Public Citizen’s Health Research Group, came a few days prior to publication of a study in the Journal of American Medical Association by researchers from Ortho-McNeil and the University of Virginia.

Public Citizen claims that a question in a press kit distributed by the University of Virginia implies that physicians can prescribe Topamax for alcohol dependence. Topamax is not approved by the FDA for the treatment of alcohol dependence.

Promotion of a drug for off-label use is not only illegal, it can be dangerous. Marketing approval by the FDA indicates the agency determined the benefits of using a specific drug or product for a specific condition outweighs its risks.

The study found modest improvement in the percentage of days of heavy drinking in people using Topamax as compared to those using a placebo. Alcohol-dependent people taking Topamax showed an increase of dizziness, injury, and concentration difficulty. In addition, other serious side effects associated with Topamax, including serious eye problems, decrease in sweating, increase in body temperature, kidney stones, and tingling in the arms and legs, were still present.

According to Wolfe, lack of responsive action from the FDA will send a message to the pharmaceutical industry that “you can sell more drugs, and possibly injure more people, by promoting off-label uses whose benefits have not been proven to outweigh their risks. And, don’t worry, we will not stop you.”

Source: “Letter to the FDA urging action against a campaign promoting the unapproved use of Topamax for treating alcoholics (HRG Publication #1825),” Health Research Group of Public Citizen, October 9, 2007.