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EMA updates GSK flu vaccine guidance

The European Medicines Agency has recommended the product label for GlaxoSmithKline's flu vaccine Pandemrix be revised to include information about a possible increased risk of narcolepsy in children

The European Medicines Agency (EMA) has recommended the product label for GlaxoSmithKline's (GSK) flu vaccine Pandemrix be revised to include information about a possible increased risk of narcolepsy in children.

The label will advise healthcare professionals to perform an individual benefit-risk assessment for each patient in relation to the information about narcolepsy.

This is an interim measure pending the outcome of the European review, expected to conclude in July 2011.

The EMA's Committee for Medicinal Products for Human Use (CHMP) announced the revisions following recent epidemiological studies covering use of the vaccine in the populations of Finland, Sweden and France.

The Swedish study looked at data from October 2009 to December 2010, with results indicating a four-fold increase in cases of narcolepsy in children and adolescents who received Pandemrix compared with unvaccinated people of the same age. Similar results were found in France and Finland.

Results in other EU and non-EU countries saw no clear relationship between the use of Pandemrix and narcolepsy, however, with the EMA stating current findings 'may point towards the influence of other unknown factors affecting the trend seen in some countries.'

There is also no 'clearly identified biological plausibility' for why Pandemrix should cause narcolepsy, according to the EMA.

In a statement, GSK said: 'GSK maintains that further information must be gathered on a potential likelihood of a causal relationship between Pandemrix and narcolepsy before any conclusions can be drawn. It is important to wait for the results of the ongoing European investigation, which includes an epidemiological study of narcolepsy and pandemic vaccines across a network of research and public health institutions (VAESCO) in nine European Union Member States.'

According to the company, over 31 million doses of Pandemrix have been administered worldwide.

18th April 2011

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