GlaxoSmithKline denies restless legs drug claim

GlaxoSmithKline (GSK) has defended itself against accusations that it promoted an unlicensed drug, ropinirole, for the treatment of restless legs syndrome.

It has also faced claims that it exaggerated the severity of the syndrome, also known as Ekbom’s syndrome. Ropinirole, marketed as Adartrel, has been approved as a treatment for Parkinson’s disease. In April 2006, the drug was also licensed for use in patients with restless legs syndrome.

The Association of the British Pharmaceutical Industry’s prescription medicines code of practice authority has deemed that GSK breached regulations by promoting the drug when it was unlicensed for treating restless legs syndrome, conceivably encouraging some patients to ask their doctor to prescribe the drug, according to the Sunday Times.

However, a spokesman for GSK told the newspaper: “There are strict rules in the pharmaceutical industry code of practice that govern the provision of information on an unlicensed condition and GSK takes these very seriously.”

Restless legs syndrome is common and may be under-diagnosed, according RLS:UK, a newly formed academic group that promotes awareness of the syndrome. It claims that the condition can cause “considerable discomfort” during the day and while sleeping.

Although data regarding prevalence is not yet available in the UK, RLS:UK has said that up to eight per cent of Americans are thought to suffer from restless legs syndrome and 5.8 per cent of Swedish men.

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