- The Washington Times - Friday, November 18, 2005


The anti-flu drug Tamiflu is safe, federal health advisers said yesterday, after finding no direct link between the drug and the deaths of 12 Japanese children who had taken it.

“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,” said Dr. Robert Nelson, chairman of the Food and Drug Administration’s Pediatric Advisory Committee. “There is no evidence that this will.”

The committee reviewed Tamiflu as part of a routine safety check of drugs for which the original uses had been extended to cover children.

Interest was raised, however, because the drug is key in the arsenal of treatments for flu pandemics.

Tamiflu is one of the few drugs believed to be effective in treating bird flu, which health officials fear could spark a pandemic should it mutate into a form easily passed from human to human. To date, there is no evidence the avian flu has mutated to this form.

The FDA committee voted unanimously that no change was needed in the label to reflect the deaths of the Japanese children. But it did say that information should be added to the label about serious skin reactions.

There have been no reports of deaths linked to Tamiflu in the United States or Europe. Melissa Truffa of the FDA’s Office of Drug Safety told the panel earlier yesterday that they found no direct link between the use of Tamiflu and the deaths in Japan.

The FDA staff said Tamiflu is used much more often in Japan than in the United States — 11.6 million prescriptions for children in Japan between 2001 and 2005, compared with about 872,000 in the United States.

An official with the drugmaker Roche Holdings AG told the commission that there are 10 times the number of adverse reactions to the drug in Japan than in the United States and about 10 times the number of prescriptions. He said that studies show no higher mortality rates for users of Tamiflu versus nonusers.

In addition to the deaths, briefing material prepared by the 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.

Roche said several studies in the United States and Canada had shown that the incidence of death in influenza patients who took Tamiflu was far lower than in those who did not.

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