WHO to review GlaxoSmithKline's flu drug Pandemrix after narcolepsy link

3 February 2011

The World Health Organization has said it is reviewing the safety of UK pharma giant GlaxoSmithKline's (LSE: GSK) Pandemrix H1N1 flu vaccine after a Finnish study suggested children who got the shot were nine times more likely to suffer from the rare sleeping disorder narcolepsy.

Pandemrix has previously been the subject of a revive by the European Medicines Agency regarding a link to narcolepsy, but last year supported continued use of the product, concluding that the available data are insufficient to demonstrate a causal relationship between its flu vaccine and the observed cases of narcolepsy And that any temporary restriction on the use of Pandemrix is not considered warranted (The Pharma Letter September 24, 2010).

The National Institute of Health and Welfare of Finland issued a statement indicating an increased risk of narcolepsy observed among children and adolescents vaccinated with Pandemrix, an adjuvanted pandemic H1N1 vaccine manufactured by GSK.

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