From the "...Now they tell us."-Files.
My non-medical-but-intelligent-and-intuitive-opinion is this:
Do Not give kids Tamiflu - or take it yourself, for that matter - Unless you are facing life-threatening flu Sx (Symptoms)... *Of course, check with your physician regarding any health or drug-related issues*. I'm no doctor. But I know better than to blindly trust the FDA or the Pharmaceutical industry!
* There's a second article included, published in 2004(!), that brought up a possible link between Tamiflu and bizarre behaviour - leading to some deaths - in children... Where the FDA basically pooh-poohed people's concerns. My question... Are there any former heads of Roche (manufacturer of Tamiflu) on the Label Board of the FDA??!


*Psst! Here's a little known Fact: Tamiflu Patent Holder is Gilead Corporation: Whose former executive and still major shareholder is...
Donald Rumsfeld! (Yes, THAT Donald Rumsfeld.)
What a Coincidence! ( - i don't believe in coincidence.)
Talk about creepy!
-L



FDA Proposes 'Abnormal Behavior' Warning for Tamiflu Label
BY ANDREW BRIDGES

WASHINGTON Nov 13, 2006 (AP).. Doctors and parents should watch for signs of bizarre behavior in children treated with the flu drug Tamiflu, federal health officials suggested Monday in citing an increasing number of such cases from overseas.

Food and Drug Administration officials still don't know if the more than 100 new cases, including three deaths from falls, are linked to the drug or to the flu virus or a combination of both. Most of the reported cases involved children.

Still, FDA staff suggested updating Tamiflu's label to recommend that all patients, especially children, be closely monitored while on the drug. They also acknowledged that stopping treatment with Tamiflu could actually harm influenza patients if the virus is the cause of delirium, hallucinations and other abnormal behavior, such as aggression and suicidal thoughts.

The FDA's pediatric advisory committee is to discuss the recommendation Thursday. The FDA isn't required to follow the advice of its outside panels but usually does. An FDA spokeswoman did not immediately return a call seeking comment.

The meeting comes a year after the same panel of outside experts rejected linking Tamiflu to reports of 12 deaths in Japanese children since 2000 and voted against changing the drug's label to suggest any such concern. At that time, however, the committee did recommend that the FDA continue to monitor the drug's safety and return a year later with an update.

The panel's decision after reviewing the new update is likely to be closely watched, since Tamiflu could play an important role in an outbreak of bird flu. The drug doesn't prevent flu but can reduce the length and severity of its symptoms.

Most of the 103 new cases of bizarre behavior are from Japan, where the number of Tamiflu prescriptions is about 10 times that in the United States, with more than twice the population.

The new cases occurred during a 10-month period, between Aug. 29, 2005, and July 6, 2006. The tally marks a sharp increase to the 126 similar cases logged over the more than five years between the drug's approval in 1999 and August 2005, the FDA said.

The Japanese Tamiflu label now warns that disturbances in consciousness, abnormal behavior, delirium, hallucination, delusion and convulsion may occur. It also recommends patients be carefully monitored and the drug stopped if any abnormality is observed.

Even though severe cases of the flu can spark those conditions, the number and nature of the cases along with comments from doctors who believe the abnormal behavior was associated with the drug keep the FDA from ruling out Tamiflu as the cause, according to agency documents.

For that reason, the proposed changes would bring the U.S. label more in line with the Japanese one, and warn of abnormal behavior and recommend that patients, especially children, be closely monitored. However, the proposed U.S. version would recommend treatment be stopped only on a doctor's advice.

FDA staff called the proposed changes "prudent," since U.S. Tamiflu use could jump to Japanese levels. The current U.S. label mentions only "seizure and confusion" seen in some patients.

Tamiflu is made by the Swiss pharmaceutical company Roche Holding AG. A Roche spokesman did not immediately return messages seeking comment. Previously, Roche has cited studies from the United States and Canada that show the death incidence rate of influenza patients who took Tamiflu was far below those who did not.

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.


The following article was published 2 years ago... alarms should have been sounded! -L.
From: Science News, on Monday, November 24, 2004.(Two Years Ago!)

*************************************************************************************

"What, Us Worry?"

What, Us Worry?


The FDA says don't sweat the reports from Japan (*Update* And now, in 2006, cases of bizarre behaviour in children, induced by Tamiflu, are being reported from Europe.) linking Tamiflu with serious side effects in a small number of 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 FDA's Pediatric Advisory Committee. "There is no signal the drug is doing it, as opposed to the disease."

The committee, which often meets in obscurity, found the world watching as it conducted a routine review of a drug that could play an important role in a pandemic caused by bird flu.The committee, in a unanimous vote, said not to worry. At the same time, though, it said it would continue to monitor reactions to the drug.

There's just one problem. The kids in Japan in didn't die from influenza. They died from hallucination-induced bizarre behavior.

THE antiviral drug Tamiflu, being stockpiled by governments around the world as a defence against bird flu, is believed to have caused the deaths of two Japanese teenagers. According to Health Ministry and other medical sources, it appears that the drug induced hallucinations and dramatic shifts in behaviour in the boys, which led them to commit suicide. Rokuro Hama, the doctor who made the connection, is the head of the Japan Institute for Pharmacovigilance and gave details of the incidents at a medical conference at the weekend.

Dr Hama believes that Tamiflu was linked to a third case in which a teenage girl was narrowly prevented from jumping from a window two days after starting a course of the drug.

Let's hope the FDA took a closer look at the evidence than the public statement of one member seems to indicate.

The safety of Tamiflu in children has been questioned before, and there's at least some reason to be on the lookout for central nervous side effects - especially in children, a population that doesn't see a lot of heavy Tamiflu use.

Based on the Japanese experience, I'd be reluctant to use it in a child. The Japanese have the highest rate of Tamiflu use in the world. A rare side effect would be more likely to reveal itself there than here. Unless there was an extremely virulent strain of influenza going around, it might not be worth the risk.

UPDATE: Looks like the FDA did a decent job of considering the possibilities behind the Japanese teenage Tamiflu deaths: Initially, it was not clear why the neuropsychiatric adverse events and deaths were reported almost entirely in Japanese children. The FDA receives adverse event reports from all over the world and usually adverse events are roughly the same from different reporting countries. The reports of death and neuropsychiatric events associated with Tamiflu, almost entirely from Japan, was unusual enough to prompt further evaluation. The FDA requested additional information from both Hoffman-La Roche, the pharmaceutical company which produces Tamiflu, and the Japanese Ministry of Health, Labor, and Welfare. FDA then evaluated several possible explanations for the neuropsychiatric adverse events.Was it possible that Japanese patients metabolize Tamiflu differently than American or European patients or have higher levels of the drug in their bodies? There is no scientific evidence that this is true and Japanese dosing recommendations are very similar to U.S. and European recommendations.

Was it possible that these events were an unusual manifestation of influenza infection? There is good evidence that neuropsychiatric events can occur with influenza, in the absence of Tamiflu or other treatment. Beginning in the mid-1990s, there have been many reports in the pediatric scientific literature describing a syndrome of influenza-associated encephalitis (inflammation of the brain) or encephalopathy. These reports originated primarily from Japan where pediatricians described a pattern of rapid onset of fever, accompanied by convulsions and altered level of consciousness, progressing to coma within a few days of the onset of flu symptoms. This syndrome frequently resulted in death or significant neurologic sequelae. These reports prompted nationwide surveillance of influenza-associated encephalopathy in Japan. This syndrome was described and the surveillance in Japan was in progress before Tamiflu was approved for the treatment of influenza.

Was it possible that the large number of adverse events from Japan was because the Japanese use more Tamiflu? Is it possible that we may see more U.S. cases as use of Tamiflu increases in this country? Partly because of the awareness in Japan of influenza-associated encephalopathy, the Japanese health service will pay for rapid diagnostic testing for influenza in children and subsequent treatment. Japan currently uses the majority of the world's supply of Tamiflu distributed for seasonal influenza. It is possible that some of these events might be observed in the U.S. population if the use of Tamiflu increases substantially.

Finally, was it possible that the neuropsychiatric events reported from Japan reflect different methods and requirements for adverse event reporting? Both the Japanese Ministry of Health, Labor and Welfare and Roche confirmed that Japanese regulators require an intensive period of active adverse event reporting for 6 months after a product is approved.

When Tamiflu was approved for prophylaxis of influenza in Japan, Roche and its Japanese pharmaceutical affiliate actively solicited adverse event reports from 70,000 institutions and physicians in Japan. These adverse event reports included the 2003-04 flu season and were subsequently reported to the FDA and are included in the BPCA safety review.

It is particularly difficult to assess the relationship of Tamiflu to the reported pediatric deaths. It is known that young children (less than 2 years of age) are hospitalized more often for influenza-associated illness than older children and young adults. Infants and the elderly are known to have higher influenza-associated death rates than other age groups.

However, in the U.S., influenza deaths in children were not among the events requiring reporting to public health departments and the CDC until the 2004-05 flu season.Review of the available information on the safety of Tamiflu in pediatric patients suggests that the increased reports of neuropsychiatric events in Japanese children are most likely related to an increased awareness of influenza-associated encephalopathy, increased access to Tamiflu in that population, and a coincident period of intensive monitoring adverse events.

Based on the information available to us, we can not conclude that there is a causal relationship between Tamiflu and the reported pediatric deaths. MedPundit 04:00 Nov-21,2004