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Originally published July 19 2008

FDA Panel Seeks to Water Down Warnings on Tamiflu Side Effects

by David Gutierrez, staff writer

(NaturalNews) An FDA advisory panel has recommended that warning labels for the flu drug Tamiflu be amended to emphasize that the reported side effects might also occur in flu patients who are not taking the drug.

After reports of nearly 600 psychiatric side effects since the drug's introduction in 1999, the FDA asked an advisory panel to review whether the warning label on Tamiflu should be strengthened. The use of Tamiflu has been heaviest in Japan, where there have been reports of at least 14 deaths due to neuropsychiatric symptoms among flu patients taking the drug. According to the FDA, five children under the age of 17 died after "falling from windows or balconies or running into traffic."

There have been a total of 25 deaths linked to Tamiflu, three of them in the United States.

Tamiflu, known generically as oseltamivir, is an anti-viral medication that can be used to treat or prevent influenza. When used as a treatment, it reduces the duration of flu symptoms by approximately one day. South Korea has issued a warning against prescribing Tamiflu to teenagers, while in Japan the warning includes children as young as 10.

But while the FDA panel recommended that the warning label on Tamiflu be strengthened to note that psychiatric episodes linked to the drug's use have resulted in serious injury or death, it also voted 8-6 to note that such reactions may be due solely to the influenza virus.

"It is still difficult to determine if these events are due to drug, disease, or both," said FDA safety reviewer Adrienne Rothstein.

According to dissenting FDA panel member Michael E. Fant, the very fact that the drug's psychiatric side effects have been under discussion for more than two years is worrisome.

"That in and of itself says we have enough concern that it warrants conveying those concerns to the public," Fant said.

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