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FDA asserts Tamiflu is safe and effective

/ Source: The Associated Press

Tamiflu is a safe and effective treatment for the flu, federal health advisers said Friday, finding 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,” said 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 on Friday because it was conducting a routine review of a drug that could play an important role in a 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 any adverse 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. “There is no evidence that this will.”

Routine safety check

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.

It was in Japan where 12 children taking the drug have died since the year 2000. 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. Those cases included delirium, hallucinations, convulsions and encephalitis.

There have been no reports of deaths linked to Tamiflu in the United States or Europe. But the events in Japan were enough to prompt further evaluations by the United States.

FDA staff said it found no direct link between the use of Tamiflu and the deaths.

Melissa Truffa of the FDA’s Office of Drug Safety said there were too many factors involved. They include the use of other medications in some of the children, the presence of other medical conditions besides flu, and lack of details in the reporting of some of the deaths.

The committee voted unanimously that no change was needed in the label to reflect the deaths or other adverse effects. But it did say information about serious skin reactions should be added to the label.

The FDA is not bound by its advisory committee recommendations, but usually follows them.

Tamiflu, manufactured by Roche Holdings AG, does not prevent the flu, but can reduce the severity and length of the illness.

Nelson said the FDA should remain vigilant despite the finding that there was no reason for concern about the drug at this point.

The committee asked the FDA staff to provide an update in about a year on any adverse reactions associated with Tamiflu. A full report should be made in two years, the panel said.

Advisory committee members noted that Japan treats the flu more seriously than the United States. Indeed, the number of prescriptions for the antiviral in Japan is about 10 times that of the United States, even though Japan’s population is half that of the U.S.

Joseph Hoffman, a vice president at Roche, said that helps to explain why the number of adverse events reported in Japan was about 10 times greater than in the United States.

“We heard from one of our colleagues, and this is a direct quote: ‘We love Tamiflu in Japan,”’ Truffa said. “I thought that was interesting.”

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

Japan’s Health Ministry warned last week that Tamiflu may induce “strange behavior” after reporting that two teenage boys died shortly after taking the medicine.

The Japanese distributor of the Roche-patented drug told health officials it could not rule out a link between Tamiflu and the deaths.

However, Roche said earlier this week that it “carefully reviewed these events and has concluded that a causal link cannot be established.”

The U.S. labeling for Tamiflu lists nausea and vomiting as its most serious side effects. Its labeling in Japan includes any adverse effects that have been reported — including impaired consciousness, abnormal behavior and hallucinations — regardless of whether they can be attributed to the drug, according to Roche.

Tamiflu is one of the few drugs believed 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.