Roche denies Tamiflu deaths link

Roche has denied any link between its Tamiflu treatment and the deaths of 12 Japanese schoolchildren. The company is due to appear today before the US Food and Drug Administration (FDA) and the EU’s drugs agency to answer questions on the treatment that has become the front line of defence against bird flu.

Tamiflu was implicated in the suicides of two school boys on Monday by Japanese authorities, and the FDA said that it is aware of 12 deaths in the past year of children taking the drug. The FDA report said that there was not enough detail available to assess the cause of the cases, but that the circumstances are “unusual” enough to require further study.

In all, the FDA said that it was aware of 75 cases of possible side effects among Tamiflu users, including complaints of psychiatric disorders and skin reactions. Of the cases, 69 had occurred in Japan, five in the US and one in Canada.

“Roche doesn’t believe there’s a link between Tamiflu and those deaths, and we are confident that Tamiflu can be used safely both by children and adults,” a spokesman for Roche told the AFP. The spokesman added that the FDA meeting is a “routine” 12 month review of several drugs approved for use in treating children under 18.

The EU Medicines Agency, however, said that it would require Roche “to provide a cumulative safety review of all available data on serious psychiatric disorders, including all case reports with a fatal outcome where Tamiflu was involved”. Governments around the world have placed huge orders for Tamiflu against the threat of a global bird flu pandemic.

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