FDA Probing Deaths of Kids Taking Tamiflu
Thursday, November 17, 2005WASHINGTON — Federal health advisers are looking into the deaths of 12 Japanese children who took Tamiflu, part of their annual safety review of the anti-flu medication and seven other drugs.
There are no reports of deaths in the United States or Europe associated with Tamiflu.
"Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children's death," Dr. Murray Lumpkin, the deputy commissioner of the U.S. Food and Drug Administration, said Thursday.
The Japanese deaths were detailed in papers released in advance of a Food and Drug Administration advisory committee meeting Friday.
An update by FDA staff also includes reports of 32 "neuropsychiatric events" associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.
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