August 08, 2006
GSK reprimanded for unlicensed UK promotion of restless leg drug
British drugmaker GlaxoSmithKline has been reprimanded for promoting an unlicensed drug to treat the disputed condition of restless leg syndrome (RLS), The Times of London reported.
GSK ran ads in UK doctors’ magazines between September 2004 and November 2005 raising awareness of RLS – a previously unrecognized ailment also called Ekbom’s syndrome – and referred patients to a Web site of the Ekbom Support Group.
Some doctors claim the condition, characterized by cramps, pins and needles and an irresistible urge to move one’s legs, has been invented or exaggerated to help sell the GSK drug ropinirole, marketed in the UK as Adartrel. Ropinirole is sold in the US under the brand name Requip and was originally developed to treat Parkinson’s disease.
Britain’s Prescription Medicines Code of Practice Authority, set up by the Association of the British Pharmaceutical Industry, ruled GSK broke the authority’s rules by promoting an unlicensed drug.
“GSK was, in effect, directing patients to a Web site that contained misleading messages about the safety of ropinirole which might indirectly encourage patients to ask their doctors to prescribe it,” the authority said.
A spokesman for GSK said: “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.”