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"The FDA has been studying reports of 12 deaths and 32 cases of psychiatric problems in children who took the drug. All of the psychiatric events, which included hallucinations and abnormal behavior, also were reported in Japan. Linda Lewis, an FDA medical officer, told the committee there was "insufficient evidence to establish that deaths and neuropsychiatric events represent a safety signal associated with Tamiflu." The FDA has no current plan to add warnings about the deaths or psychiatric problems to the Tamiflu label, Lewis said. Tamiflu is used widely in Japan to treat influenza. From 2001 to 2005, there were 24.5 million prescriptions in Japan and 6.5 million in the United States." Teresa (in VA) |
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