European Medicines Agency to review GlaxoSmithKline's flu vaccine Pandemrix for possible link with narcolepsy
At the request of the European Commission, the European Medicines Agency (EMEA) says it has launched a review of UK pharma giant GlaxoSmithKline's (LSE: GSK) flu jab Pandemrix to investigate whether there is a link between cases of narcolepsy ' a rare sleep disorder - and vaccination with Pandemrix.
A limited number of cases of narcolepsy was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland. Pandemrix, an influenza vaccine, has been used since September 2009 for vaccination against H1N1 influenza in at least 30.8 million Europeans, the agency noted.
On August 24 this year, Finland's National Institute for Health and Welfare recommended that vaccination with Pandemrix be discontinued until the suspected link with narcolepsy is thoroughly evaluated. Sweden's Medical Products Agency (MPA) has also started to investigate the H1N1 vaccine.
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