Originally published December 7 2005
FDA panel decides Tamiflu not linked to deaths of 12 Japanese children
by Mike Adams, the Health Ranger, NaturalNews Editor
Dr. Robert Nelson, chairman of the FDA's Pediatric Advisory Committee, oversaw the decision that cleared Tamiflu in the deaths of 12 Japanese children over the past several years.
An advisory committee to the Food and Drug Administration found no direct link between the drug and the deaths of 12 Japanese children over the last few years.
"Kids die of influenza, both in Japan and the United States, and if you give a drug to people who are at risk of dying, there will be people who die who got the drug," said Dr. Robert Nelson, chairman of the FDA's Pediatric Advisory Committee.
The committee, which often meets in obscurity, found the world watching as it conducted a routine review of a drug that could play an important role in a pandemic caused by bird flu.
At the same time, though, it said it would continue to monitor reactions to the drug.
"If we ever have a pandemic of avian flu, which is a debatable point, people want to know that they have a drug that will not cause more (harm) than the flu itself," Nelson said.
The committee reviewed Tamiflu as part of a routine safety check of drugs whose original uses had been extended to cover children.
The panel not only reviewed data from the United States but from Japan, where the antiviral is in much demand.
In addition to the deaths, FDA staff briefing materials include reports of 32 "neuropsychiatric events" associated with Tamiflu, all but one experienced by Japanese patients.
Melissa Truffa of the FDA's Office of Drug Safety said there were too many factors involved to link the adverse reports to Tamiflu.
Those factors include the use of other medications in some of the children, the presence of other medical conditions, and lack of details in the reporting of some of the deaths.
The committee determined that no change was needed in the label to reflect the deaths or other adverse effects.
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