[NVIC] Teens Hallucinating, Dying After Tamiflu

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" Protecting the health and informed consent rights of children since 1982. "

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BL Fisher Note:

Will the same researchers connected with drug companies selling these drugs

for profit and government officials both regulating and promoting their use

be in charge of " looking into " Tamiflu-related deaths? Will the new

" partnership " between federal health agencies and industry really lead to

the the truth about drug and vaccine-related injuries and deaths? There is a

very good reason why big Pharma is fighting so hard to get Congress to

remove all liability for injuries and deaths caused by vaccines and drugs

that will be used on a mass basis: they know that many will be hurt and they

don't want to pay for it.

http://www.nytimes.com/2005/11/18/health/18tamiflu.html

The NY Times

November 18, 2005

Childhood Deaths in Japan Bring New Look at Flu Drug

By ANDREW POLLACK

The Food and Drug Administration is looking into reports of deaths and

abnormal behavior among children in Japan who took the anti-influenza drug

Tamiflu, which is being stockpiled by governments around the world for use

in a possible flu pandemic.

The agency said that given the available information, it could not conclude

that Tamiflu had caused the deaths and other problems. It plans to continue

monitor possible complications from the drug for up to two years.

Roche, the company that sells Tamiflu, said that the reports of these

problems were rare given that millions of people had used the drug, and that

the problems might have been caused by the flu itself.

The issue of Tamiflu's safety in children will be discussed today by an

advisory committee to the F.D.A. at a meeting in Gaithersburg, Md. Such a

safety review is required one year after a drug receives a patent extension

offered to companies that test the safety and effectiveness of their

medicines in children.

Seven other drugs will also be discussed at the meeting, but most of the

time will be devoted to Tamiflu, also called oseltamivir. While the

discussion is not directly related to planning for a pandemic, the F.D.A.

said that a better understanding of the safety of Tamiflu for children would

be useful in such a situation.

Tamiflu was approved in 1999 in the United States and late in 2000 in Japan.

In documents prepared for the meeting, F.D.A. reviewers said 12 children,

ages 1 to 16, had died after taking the drug, all of them in Japan. In one

document, the reviewers commented on the death of six children ages 2 to 4

who had apparently been healthy before getting the flu. " It is concerning

that six young patients died suddenly within one to two days after

initiation of oseltamivir therapy, " the reviewers wrote.

The documents also said there had been 32 instances of " neuropsychiatric

events, " 31 of them in Japan, including delirium, abnormal behavior and

hallucination.

Two boys, one 12 and one 13, jumped from the second-story windows of their

homes after receiving two doses of Tamiflu. Those boys survived, but

Japanese news reports have told of two teenagers taking Tamiflu whose death

may be attributable to suicide. And an 8-year-old boy had a frightening

hallucination and rushed out of his house into the street three hours after

his first dose.

There have also been reports of severe skin reactions, in Japan and other

countries and in adults as well as children.

One reason so many of the reports are from Japan could be that the drug is

used far more widely there than in any other country. Of the 13 million

prescriptions written for children worldwide, 11.6 million have been in

Japan, according to Roche. That could mean that rare side effects are being

seen first in Japan.

But, the F.D.A. said, there may be other reasons. For one, Japanese doctors

seem to be more aware of brain inflammation caused by flu itself. That could

lead to greater reporting of problems experienced by flu patients, some of

whom happen to take Tamiflu.

Roche said that the death rate among children taking Tamiflu was only one in

a million and that the rate of death and other problems was no greater than

in children with the flu who did not take the drug.

" There is the complicating factor of the disease itself causing these

effects, " Dr. ph Hoffman, a vice president for pharmaceutical

development at Roche, said in an interview. He said that in some of the

cases of possible side effects, other causes might exist, including other

drugs the patients were taking.

Dr. Hoffman also said that one study using data from an insurance company

suggested that the use of Tamiflu could reduce the death rate from flu.

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