EU agency flags narcolepsy risk on GSK flu shot

European regulators have recommended changes to the product label for GlaxoSmithKline’s pandemic flu vaccine Pandemrix to highlight the potential risk of narcolepsy in children or adolescents. The decision is based on preliminary results of studies from Finland, Sweden and France suggesting a possible link between the vaccine and the rare sleeping disorder. The move does not apply to adults. The European Medicines Agency said on Friday the step had been taken as an interim measure, pending the outcome of the European review expected to conclude in July 2011. GSK said it believed further information was needed on the likelihood of a causal relationship between Pandemrix and narcolepsy before any conclusions could be drawn. More than 31 million doses of Pandemrix have been given to people in 47 countries and the company said it had been notified of 247 cases of narcolepsy in those vaccinated as of April 5. “It is important to wait for the...