From Flu Wiki 2

Forum: Tamiflu and Children Warning

13 November 2006

Kathy in FL – at 14:16

Tamiflu may get ‘abnormal behavior’ label

WASHINGTON - 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 the delirium, hallucinations and other abnormal behavior.

<snip>

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.

<snip>

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.

<snip>

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.

Kathy in FL – at 14:18

Direct link for the above article:

http://tinyurl.com/y69max

Leo7 – at 15:43

Glad you started this thread Kathy in FL. Tamiflu revelations are falling like rain. We did hear about the Japanese experience months ago but it was low key. Now they’re taking warning labels. Those side effects must have been fearsome. A lot of people take Plavix for cardiovascular disease and now the reports say Plavix cancels out the effects of Tamiflu. If this keeps up, Roche will have a stock drop.

Ruth – at 16:00

As my father once said, always be watchful when a new or newer drug or vaccine is administered to the masses. Don’t be first in line.

diana – at 16:06

Save the Tamiflu for the H5N1 varient. To give it to children for a mild case of flu seems to be overkill.

MaMaat 16:49

Kathy in FL, thanks for posting this. It is frightening to contemplate how many people may be planning to use Tamiflu and have no idea of the risks involved.

I hope you don’t mind but I posted this story on Monotreme’s site, crediting you of course:-) The more people it reaches, the better.

LauraBat 16:55

Even if I had some, I would only give it to my kids if it was a PF situation and I was relatively certain they had something life threatening. With the exception of the very young, very old and immuno-supressed, I would hesitate giving antivirals like Tamiflu to most anyone. They all seem to have side effects. Yes, it sucks being sick, but in the vast majority of cases all turns out well without the need for medication. Seems often the “cure” is worse than the illness.

14 November 2006

Kathy in FL – at 11:34

MaMa – at 16:49

You are more than welcome to re-post anything. I got this off of the AP yesterday and am now seeing it in a lot of local newspapers, right dow to the little, small-circulation, entertainment types.

anon_22 – at 15:24

diana – at 16:06 Save the Tamiflu for the H5N1 varient. To give it to children for a mild case of flu seems to be overkill.

I agree 100%.

Okieman – at 19:48

It may sound conspiratorial, but could this not be something that has been put forth and built up so as to significantly reduce the use of Tamiflu for regular season influenza? By doing this, there will likely be more in stock if/when a pandemic starts this winter than if they did not raise this “warning”. One of my concerns has been that a pandemic would occur at the tailend of an active (normal) flu season, when Tamiflu stocks have been depleted in the northern hemisphere.

Now, this warning may all be on the up-and-up, but I do wonder…

Lisa the GP – at 20:20

In the event of a real panflu involving H5N1:

risk of death from untreated flu: >50% risk of death from use of Tamiflu: <<<<50%

It’s not that hard a decision.

Lisa the GP – at 20:21

grr. Lost some formatting. Imagine I line break after “>50%”

NJKME – at 20:29

Dr. Lisa @ 20:20

good point. I’ve made the decision to fill script that my pediatrician gave me for my 2 boys and keep it in storage for just in case.

DemFromCTat 20:55

Okieman – at 19:48

My recollection, poor as it is, was that the issue was to be studied when we first spoke about it. This seems that this is the product of the review.

The warning seems appropriate; the advice to use it if we’re really talking about H5N1 also seems appropriate (risk-benefit). It might give pause to people using it in an H3N2 ordinary flu, at least with children. But as some have noted, the symptoms could also have been from flu.

15 November 2006

Urdar-Norway – at 16:40

the issues on sideeffcts are small potato. Tamiflu shouldent be used on normal flu anyway exept for severe cases. But how does this mix with the planned keyworkers in large numbers using tamiflu as prophylacs to prevent illnes. I hate to se a lot of police, sanitation workers etc getting illusions etc.. :-/

Olymom – at 23:47

What I’m not seeing in the newspaper articles is the frequency — I understand that the Japanese routinely use Tamiflu to treat flu — so are we talking about 139 cases of side effects out of thousands of doses? Millions of doses? Hundreds of millions of doses? The frequency of side effects is an important aspect of this.

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