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Published on 27 November 2007

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FDA issues flu drug recommendations

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The Food and Drug Administration (FDA) has recommended that flu drugs made by Roche and GlaxoSmithKline (GSK) should carry warnings on their labels about neurological problems seen in children.

The move comes after the FDA released its safety review of Roche’s Tamiflu and GSK’s Relenza on Friday.

The agency began reviewing Tamiflu’s safety in 2005 after receiving reports that children had experienced neurological problems, including hallucinations and convulsions.

Twenty-five patients under the age of 21 have died while taking the drug, most of them in Japan. The agency said that five of the deaths occurred after children “fell from windows or balconies or ran into traffic”.

Although there have been no child deaths connected with Relenza, the FDA said children taking the drug have shown similar neurological problems.

While the agency said it is not clear whether the problems are directly related to the drugs, it is recommending that details about the possible side effects should be added to labels on both of them.

The agency said it was also possible that the behaviours could be related to an unusual strain of flu or a rare genetic reaction to the drug.

Copyright © PA Business 2007

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