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Taking TOPAMAX to Treat Alcoholism Could Have Serious Consequences

Worst Pills, Best Pills Newsletter article December, 2007

A New Study Mistakenly Suggests that the Drug is Useful for Treatment of Alcoholism

The Journal of the American Medical Association (JAMA) published a study suggesting that the popular migraine and seizure drug topiramate (TOPAMAX) could also be used help treat alcoholism. This drug is not approved by the Food and Drug Administration (FDA) for that purpose.

“Plausibly, individuals with certain subtypes of alcoholism might benefit the most from treatment with topiramate,” according...

A New Study Mistakenly Suggests that the Drug is Useful for Treatment of Alcoholism

The Journal of the American Medical Association (JAMA) published a study suggesting that the popular migraine and seizure drug topiramate (TOPAMAX) could also be used help treat alcoholism. This drug is not approved by the Food and Drug Administration (FDA) for that purpose.

“Plausibly, individuals with certain subtypes of alcoholism might benefit the most from treatment with topiramate,” according to the article published on Oct. 10, 2007.

However, upon closer inspection, the study does not convincingly prove the safety or effectiveness of the new suggested use of topiramate. The use of the drug produced only a modest decrease in the percentage of days of heavy drinking, compared to placebo. 

The JAMA study included only heavy drinkers. For men, heavy drinking was defined as 35 or more drinks per week; for women, the minimum number was set at 28 drinks per week. Subjects were not followed for very long; the entire study lasted only 14 weeks. At the beginning of the study, subjects taking topiramate and subjects taking placebo subjects were already drinking heavily (five or more drinks per day for men, four or more per day for women) on 82 percent of days. By the end of 14 weeks, subjects in the topiramate group had decreased this figure to 44 percent. But subjects who did not receive any drug (placebo group) had also decreased to about 52 percent, an unimpressive 8 percent difference. 

At the same time, the study provided evidence that the medication has troublesome, frequent and sometimes dangerous side effects when used to treat alcoholism. The study showed that patients taking topiramate experienced a statistically significant increased incidence of dizziness (doubled), anorexia (tripled), difficulty with concentration/attention (quadrupled) and taste perversion (nearly quintupled), compared to subjects taking a placebo. In addition, the drug quadrupled the incidence of paresthesia (tingling in the fingertips) – remarkably, about half of the people taking topiramate experienced this side effect. And even with these side effects, both groups were still drinking quite heavily at the end of the study.

Topiramate can be unsafe if mixed with alcohol. Current FDA labeling for the approved uses of the drug states, “You should avoid drinking alcohol while taking [topiramate]. Alcohol with [topiramate] can make side effects such as sleepiness and dizziness worse.”

Topiramate’s side effects have not escaped the FDA’s attention. In Dec. 2003, the FDA required Ortho-McNeil to send a strong warning letter to doctors stating that topiramate has caused metabolic acidosis, a very serious and sometimes life-threatening abnormality in acid-base balance in which the body becomes too acidic. Some of the side effects caused by metabolic acidosis include rapid breathing, fatigue, irregular heartbeats, stupor and kidney stones (see Worst Pills, Best Pills News, February 2004).

Serious Side Effects of Topiramate Described in the FDA-Approved Patient Information
  • Metabolic acidosis. Metabolic acidosis is a condition that occurs when there is too much acid in your blood. Metabolic acidosis can cause symptoms such as tiredness, loss of appetite, irregular heartbeat and impaired consciousness.
  • Eye problems. Serious eye problems include:
    • A sudden decrease in vision with or without eye pain
    • A blockage of fluid in the eye causing increased pressure in the eye. (Call your healthcare professional right away if you have a loss in vision or get eye pain. These problems can lead to blindness if not treated right away.)
  • Decreased sweating and increased body temperature (fever). Patients, especially children, should be watched closely for signs of decreased sweating and fever, especially in hot temperatures. Some patients may need hospital treatment for this condition.
  • Kidney stones. Drink plenty of fluids when taking topiramate to decrease your chances of getting kidney stones.
  • Tingling of the arms and legs (paresthesia). This is a common side effect of topiramate.

What You Can Do
Do not use topiramate to treat alcohol dependence or for weight loss (another off-label use of the drug). This drug is only approved by the FDA to treat seizures and migraines.

Is TOPAMAX Being Illegally Marketed as an Alcoholism Treatment?
The industry-funded researchers who authored the Journal of the American Medical Association (JAMA) study have been publicizing the use of topiramate (TOPAMAX) to treat alcoholism, a use for which the drug is not approved by the Food and Drug Adminstration (FDA).

There may technically be nothing wrong with such publicity, if the researchers generated it and sent it out independently. But if Ortho-McNeil Janssen,TOPAMAX’s manufacturer, was involved in the creation or dissemination of the information, or if company funding played any role in this publicity campaign – that could be a violation of federal law.

Here’s what we know, based on the documents we have seen: The University of Virginia, the venue where the study was conducted with funding from Ortho-McNeil, sent members of the media information kits including the JAMA article as well as additional information that implicitly promotes the use of the drug for alcoholism. The lead author, from the University of Virginia, is also a consultant to Ortho; six of the other authors are full-time employees of Ortho-McNeil.

These kits include a question-and-answer sheet asking “Can my doctor prescribe me topiramate for alcohol dependence?” The answer, in effect, is yes: “Since topiramate is currently FDA-approved for seizures and migraines, it is available to your doctor to prescribe it to you off-label.”

Doctors are legally able to prescribe drugs for “off-label” uses – those uses for which a drug is not FDA-approved. In fact, topiramate already has an off-label use – it has been prescribed as a weight-loss drug despite the fact that the FDA has not approved the drug for this purpose because it has never been proven to be a safe or effective weight-loss agent. 

So the university is within its rights to state that doctors can prescribe the drug for off-label uses. But if the drug manufacturer had any hand in writing or funding the distribution of those media kits, it’s another story.

FDA laws and regulations prohibit manufacturers from promoting or advertising off-label uses of their products. This is designed to prevent widespread use of drugs for purposes that the FDA has not fully evaluated.

If the promotional materials were directly provided or approved by topiramate manufacturer Ortho-McNeil Janssen, this would be a clear violation of the prohibition against off-label promotion. The FDA has agreed to investigate this and if there is illegal off-label promotion, the agency needs to require the company to stop this campaign.

Disclaimer

The information on this website is not intended to substitute for professional medical advice, diagnosis, or treatment. Consult your doctor before changing or discontinuing any medication.