Gambling and Restless Legs

By: Laura Strickler
Topics: FDA

(CBS/AP)

You might have noticed that a common television ad for restless leg syndrome (RLS) now includes an unusual side effect: gambling. That's right, if you suffer from Parkinson's or RLS and suddenly find yourself in Vegas losing money you might be able to blame the drug you take. As of August 4, GlaxoSmithKline added "gambling, sexual or intense urges" to its list of side effects in its television ad for its drug Requip. The company says the warning has been disclosed in its print ads since July 2005 but this week's change to its television ad was in response to an FDA request three months ago. The FDA did not respond to requests as to why it asked for the change. But two research studies published in the Archives of Neurology since 2005 identify gambling addictions as one of the possible side effects of taking Requip or its competitor Mirapex made by Boehringer Ingelheim Pharmaceuticals. Mirapex's television advertising campaign already mentions gambling as a possible side effect.

Requip was approved in May 2005 and since then has been heavily advertised. In 2006, according to Med Ad News, GlaxoSmithKline spent $108 million advertising the drug, making it the 16th most advertised pharmaceutical in America. Figures are not yet available on the Mirapex advertising budget for RLS.

In addition to more public warnings about the gambling side effect, there are also new lawsuits filed by people who claim they have gambled away their nest eggs after they began to take drugs in this class, known as dopamine agonists.

For example, Jacquie Rice, a retired Texas banker was prescribed Mirapex off-label in April, 2004, and says she gambled away her entire retirement of $250,000. Max Wells, also from Texas, filed a lawsuit against drug companies as well as the Las Vegas casinos where he lost millions. His attorney Tom Alleman says the discovery process in the case has just begun.

The FDA says they can't comment on the number or kind of Requip adverse events that have been reported to the agency. That information is only available through a freedom of information request which can take months.

This is not the only controversy following RLS and its treatments. Industry critics have attacked pharmaceutical manufacturers for creating the disease to sell drugs. But sufferers claim it is a real problem involving serious discomfort. One anonymous patient quoted on Mirapex's site indicates they were unaware that their discomfort had a name or a treatment, "I couldn't believe it because I had all of the symptoms mentioned in the article. I was so relieved that there was a name for what had been causing me so much discomfort."

Manufacturers of RLS treatment drugs point to a recent study in the New England Journal of Medicine that indicates the disease is not only real but has a genetic cause. The Journal discloses that two of the 25 researchers who worked on the study served as paid consultants to the companies that manufacture RLS drugs. Two additional researchers also disclosed that their genetics company had a financial interest in the results of the study.

Patricia Alulema and Ariel Bashi contributed to this report.