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Last Updated: Saturday, 19 November 2005, 10:41 GMT
US clears bird flu drug Tamiflu
Tamiflu
Tamiflu is seen as a key weapon in the event of a pandemic
America's powerful medicines regulator has ruled there is no evidence of a link between the bird flu drug Tamiflu and the deaths of 12 children in Japan.

A Food and Drug Administration panel found no "causal link" between the deaths over the past 13 months and the drug, which is widely distributed.

Swiss manufacturer Roche welcomed the ruling, saying: "The positive role of Tamiflu remains unchanged."

Tamiflu, it added, would be relabelled to warn of possible skin side-effects.

Countries have placed huge orders for Tamiflu to ward off a feared pandemic that scientists fear could result from the H5N1 strain of bird flu.

'Adverse skin events'

The FDA had looked at 75 cases of mental and skin disorders - 69 of them in Japan - which raised concern about the use of Tamiflu in children.

Of the 12 deaths, four were described as sudden, one attributed to a fall during a psychiatric disturbance, and several others to heart and lung failure.

There were also 32 cases of psychiatric disturbance, including hallucinations.

The FDA panel concluded that there was no "causal link between paediatric deaths and neuropsychiatric adverse events and Tamiflu".

"We welcome the outcome of the FDA advisory committee and look forward to working with the FDA and other health authorities to extend our knowledge of the use of Tamiflu and its safety profile," said William Burns, head of Roche's pharmaceuticals division.

Roche intended, however, to "work with the FDA to change the drug's labelling based on adverse skin events that have occurred in a small number of patients, mostly in Japan".

Roche said earlier the rate of deaths and psychiatric problems was no higher among those taking its medication than among those with flu.


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