Tamiflu is safe, say US health advisers
NST, 20 Nov 2005

WASHINGTON, Sat. --- Tamiflu is a safe and effective treatment for influenza, federal health advisers said yesterday, after they found no direct link between the drug and the deaths of 12 Japanese children.

“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”, aid Dr Robert Nelson, chairman of the Food and Drug Administration’s Pediatric Advisory Committee.

“there is no signal the drug is doing it, as opposed to the disease”.

The Pediatric Advisory Committee, which often meets in obscurity, found the     world       watching       yesterday

because it was conducting a routine review of a drug that could play an important role in any pandemic caused by bird flu or another superflu strain.

The committee, in a unanimous vote, told the world not to worry. At the same time, though, it said it would continue to monitor adverse reactions to the drug.

“if we ever have a pandemic of avian flu, which is a debatable point, people want to know they have a drug that will not cause more harm than the flu itself”, Nelson said. “There is no evidence that this will”.

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 US, but from Japan, where the antiviral is much in demand.

It was in Japan where 12 children died while taking the drug since 2000. Besides the deaths, FDA staff briefing materials include reports of 32 “neuropsychiatric events” associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.

There have been no reports of deaths linked to Tamiflu in the US or Europe, but the events in Japan were enough to prompt further evaluations by the US. --- AP.