EU agency flags narcolepsy risk with GSK flu shot
LONDON, April 15 |
LONDON, April 15 (Reuters) - European regulators have recommended changes to the product label for GlaxoSmithKline's (GSK.L) pandemic flu vaccine Pandemrix to highlight the potential risk of narcolepsy in children or adolescents.
The decision is based on preliminary results from studies on the risk of narcolepsy from Finland, Sweden and France. The move does not apply to adults.
The European Medicines Agency said the step had been taken as an interim measure, pending the outcome of the European review expected to conclude in July 2011.
(Reporting by Ben Hirschler; editing by Paul Sandle)
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