November 26, 2005

FDA Says Tamiflu Did Not Cause Japan Deaths

Dr. Mercola's comments:

So, even if these drugs or vaccines wind up killing innocent children, these companies will not be held liable. But you don't have to worry as on Saturday the FDA announced that Tamiflu was safe. Of course, this is the same agency that gave Vioxx its safetly blessing before it killed 55,000 people.

Read the whole thing here.

Regulatory agency asserts Tamiflu safe

WASHINGTON (AP) — The anti-flu drug Tamiflu is safe, federal health advisers said Friday, 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 whose original uses had been extended to cover children.

Interest was raised, however, because the drug is key in the arsenal of treatments for pandemics caused by bird flu or another superflu strain.

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

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

Nelson said the FDA should still be vigilant in going forward despite the finding that there was 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 committee said.

"Influenza is a serious disease. 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," Nelson said. "There is no signal the drug is doing it as opposed to the disease."

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 Friday 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 to about 872,000 during that same period in the United States.

An official with the drug maker 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 vs. non-users.

"The absolute numbers are in the opposite direction," said Joseph Hoffman, a vice president at Roche.

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.

The company also has supplied the FDA with two additional studies it commissioned that evaluated the safety of Tamiflu in pediatric patients.

Complicating the issue is that many of the Japanese death and adverse reaction reports list symptoms commonly associated with the flu, Dr. Murray Lumpkin, deputy commissioner of the FDA, said prior to the meeting.

"It is very difficult, when the underlying disease causes what it is being reported, to figure out: Is it the underlying disease? Is it the drug?" he said.

The popularity of Tamiflu in Japan may explain in part the number of reports from that country: Of 32 million people treated with Tamiflu since its approval in 1999, 24 million were in Japan, according to Roche.

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.

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