Läkemedelsverket, Sweden's Medical Products Agency (MPA), and Finland's National Institute for Health and Welfare (THL) have begun investigating if the GlaxoSmithKline (GSK) vaccine Pandemrix is responsible for cases of narcolepsy among children treated with the H1N1 "swine flu" drug. The investigations have been launched in response to physician reports.
The MPA has received six reports from healthcare professionals regarding narcolepsy as a suspected adverse drug reaction following Pandemrix flu vaccination," the Agency said in a statement.
These reports concern children aged 12-16 years who developed symptoms of narcolepsy within two months of inoculation with Pandemrix.
In Finland, the number of narcolepsy cases reported this year was 12-14, which is much higher than the average of three cases annually. This increase has prompted officials there to consider a link between the condition and either the vaccine or the flu itself.
The Finnish cases were detected among children aged 5-15 years. Symptoms began between December and February, during the winter 2009/10 flu season, and the cases were diagnosed in early spring and summer.
Kerhi Kilpi, the director of THL's vaccine department, has said that she does not believe a link exists but that any doubts must be examined.
Preliminary results from the investigations are expected by the end of the year.
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