GlaxoSmithKline flu vacine to have narcolepsy risk warning in EU
Monday, April 25, 2011 at 12:59PM A swine flu vaccine which has been given to thousands of children in Britain may cause the sleep disorder narcolepsy. Symptoms include excessive daytime sleepiness and nodding off suddenly without warning.
All packets of the vaccine Pandemrix will have to carry a warning about the risk following a ruling by the EU regulator, the European Medicines Agency (EMA). The EMA, which is currently investigating the effects of the vaccine, has also told doctors to weigh up the potential risks before injecting children against the deadly H1N1 virus.
There have been seven reported cases of narcolepsy in the UK linked to the GlaxoSmithKline vaccine – four of them children. The condition can also cause temporary muscle paralysis, hallucinations and problems concentrating....Experts in Finland revealed last month that children who had the vaccination were nine times more likely to develop narcolepsy. And in Sweden research found the risk was four times greater.
...The label updates are intended as an ‘interim measure’ until the investigation is completed in July, the EMA said.