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FDA Riled over Approving Glaxo’s Flu Vaccine after EU Reports of Narcolepsy

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Though the precise nature of the link between GSK’s Pandemrix vaccine and narcolepsy in children is yet to be proved, numerous studies from Europe seem to indicate that children treated with Glaxo’s flu vaccine have a higher risk of contracting narcolepsy.

Narcolepsy is a chronic sleeping disorder that can cause hallucinations, cataplexy – muscle weakness forming from strong emotions – and daytime sleeplessness. Narcolepsy is often debilitating in nature.

Recent research published in the British Medical Journal found children who had received GSK’s vaccine during the swine flu pandemic had a 14-times higher risk of developing narcolepsy than normal children. Similar studies conducted in Ireland, Finland and Sweden have also concurred and scientists believe that ASO3, a compound present in the Pandemrix vaccine, may be the cause.

  
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While GSK’s Pandemrix has not yet been approved in the United States, a similar medication proposed for fighting the H5N1 bird flu epidemic has passed an FDA panel.

In November, a 14-member panel of advisors voted for the bird-flu vaccine, even after considering earlier studies from Europe linking narcolepsy with the AS03 contained in the vaccine, opining that the benefit outweighed the risks.

Why? Because, unlike swine flu, the H591 bird flu kills 60 percent of the people infected, and it is considering this angle that the FDA panel held the benefits outweighed the risks.

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WHO data released in 2011, shows, while millions had been affected by swine flu during the epidemic, only 1 percent had lost their lives. In contrast, though only 566 people have been infected so far by bird flu worldwide, 59 percent have lost their lives.

At least one committee member, Dr. Ambrose Cheung, would like FDA to reconvene the panel approving the bird-flu vaccine, but the chances of the committee changing their decision is slight. This is because of the high mortality rate of the disease in question and the lack of alternatives.



With bird-flu vaccine, it’s either don’t take it and suffer a 60 percent chance of death, or take it and bear a risk of narcolepsy.

It’s a hard choice for the FDA.

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