Restless Legs Syndrome: Two Heavily Promoted Drugs

Very likely you never heard of restless leg syndrome (RLS) before 2003. That’s when Glaxo-SmithKline launched a media campaign to promote awareness of this condition that the company described as “underdiagnosed.” Not incidentally, two years later Glaxo’s drug Requip received FDA approval for the treatment of RLS. The drug was already on the market as a treatment for Parkinson’s disease.

Within a year of its RLS approval, Requip was on track to post sales of $500 million, making it one of the fastest-growing drugs in Glaxo’s portfolio, according to the Wall Street Journal. Predictably, another company Boehringer Ingelheim got in on the action with its Parkinson’s drug, Mirapex.

Though RLS invites the usual suspicions that this is yet another illness made up by drug companies intent on expanding their markets, it appears to be real. For some people it can be disabling enough to interfere with sleep on a regular basis. But it is also likely, thanks to Glaxo’s ongoing promotional campaign with its ads aimed at doctors and the general public, that RLS is now overdiagnosed. And many people may be taking a serious drug indefinitely for a minor annoyance that could be treated non-pharmacologically or not at all.

How do you know you have it? These four criteria must be met for a diagnosis of RLS:

• An urge to move the legs due to an unpleasant feeling in the legs;
• Onset or worsening of symptoms when at rest or not moving around frequently;
• Partial or complete relief by movement (e.g., walking) for as long as the movement continues;
• Symptoms that occur primarily at night and that can interfere with sleep or rest.

Several things to keep in mind if you are taking Requip or Mirapex:

• According to company-sponsored trials, about 70% of the people on Mirapex or Requip reported a reduction in symptoms; so did more than 50% of those on placebo.
• These FDA required pre-approval trials lasted only 3 to 36 weeks; therefore the safety and effectiveness of taking a RLS drug longer is unknown.
• The precise mechanism of action of Requip and Mirapex as a treatment for RLS is unknown, according to company-generated label information.
• Because the FDA-required pre-approval studies have a relatively small number of participants and are short-term, information about a drug’s serious adverse effects usually comes out years after it comes on the market (if at all). Here is what is known to date: Both drugs can cause some people to fall asleep during everyday activities like driving, eating or talking to someone.

Have all non-pharmacological alternatives been explored?

• Try doing without any drug that can precipitate RLS, such as antihistamines, caffeine, alcohol, nicotine, as well as numerous prescription drugs, including antidepressants, anti-nausea, neuroleptics (e.g., antipsychotic drugs, major tranquilizers).
• Engage in moderate exercise, for example, a brief walk before bedtime. Avoid unusual and excessive exercise, which may precipitate RLS.

Maryann Napoli, Center for Medical Consumers ©
September 2007