Tamiflu causes abnormal behaviour

March 6, 2008

Article from: Reuters From correspondents in Washington

March 05, 2008 06:49am

US regulators and Roche Holding AG have warned doctors of psychiatric

events, some of which resulted in death, in patients taking flu drug

Tamiflu, regulators said overnight.

Drugmaker Roche wrote a letter, dated February 2008, to health

professionals advising them of a recent update to the Tamiflu label,

according to a notice posted on the US Food and Drug Administration's

website.

The revised label includes a new description of reports of delirium

and other abnormal behaviour, with some cases resulting in fatal

outcomes, the letter said.

The previous language did not mention any deaths.

The new label says the cases " appear to be uncommon " and " the

contribution of Tamiflu to these events has not been established " .

The company said the revisions reflect recommendations made in

November 2007 by an FDA advisory panel that reviewed the cases, which

have been seen mostly in Japan.

" The changes to the label reflect observations from a growing body of

data, which shows no evidence of a causal relationship between Tamiflu

and the reported adverse events, " Roche said.

The new label also notes influenza itself can be associated with

various psychiatric problems.

Roche Products Pty Limited distributes Tamiflu in Australia.

Governments worldwide have been stockpiling the drug, known

generically as oseltamivir, as a first line of defence in case the

bird flu virus sparks a human influenza pandemic.

Drug company GlaxoKline has also added a warning to its flu drug

Relenza about reports of delirium and abnormal behaviour in some

patients who took the medicine, a company spokesman said today.

" The contribution of Relenza to these events has not been

established, " the drug's revised label says.

Glaxo spokesman Jeff McLaughlin said the changes reflected input from

the US FDA advisory panel's recommendations.

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