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A U.S. advisory panel said on Friday it saw no evidence Roche AG's anti-flu medicine Tamiflu caused the deaths of 12 children in Japan but urged regulators to continue monitoring for potential risks.
"The committee does not think, based on the data presented, that there's any evidence Tamiflu played a role in the deaths," panel chairman Robert Nelson said.
The FDA has no current plan to add warnings about the deaths or psychiatric problems to the Tamiflu label, Lewis said.