This news alone should make the bta share price jump (but we know it wont)
''FDA urges new caution on Roche's Tamiflu''
From correspondents in Washington November 14, 2006 06:24am Article from: ReutersFont size:
US Food and Drug Administration staff have recommended adding a new precaution to the label of Roche AG's flu-fighting drug Tamiflu about reports of psychiatric problems.
"It is still unclear whether these neuropsychiatric events are drug-related only, disease manifestation alone, or a combination of drug-disease expression," FDA staff said in a summary dated September20 and posted on the agency's website today.
The FDA reviewers said they evaluated 103 reports of delirium, suicidal behaviour and other mental problems from August 2005 to July 2006. Three cases were fatal.
Nearly all of the cases, 95 out of 103, came from Japan, the FDA staff said.
A Roche spokesman could not immediately be reached for comment.
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