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Tamiflu: 12 children die

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Gromit | 15:01 Tue 11th Aug 2009 | News
17 Answers
Tamiflu is not safe for children doctors have warned. It follows reports that 12 children have died from the side-effects in Japan and the US are to review the risks.

The Government say it is fine, and you should still give it to your kids.

The Government have ordered 14.6million doses at a cost of �200million.

http://www.bio-medicine.org/medicine-news/US-R eviews-Risks-Of-Tamiflu-After-12-Children-Die- -5722-1/

Who would you trust?
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Gromit.

I wouldn't take Tamiflu......because the benefits are minimal and the side effects are significant.

I will not have the vaccine because of inadequate clinical trials....in my opinion.
Well not bio-medecine.org - who the heck are they?

They say

In a report posted online, the US Food and Drug Administration said on Friday that 12 children had died in Japan from causes including heart attack, suicide, pneumonia and acute pancreatitis. Four had suffered a sudden death, which was an unusual phenomenon in otherwise healthy children. All had taken Tamiflu.

But they weren't otherwise healthy were they? Otherwise they wouldn't be on Tamiflu.

It doesn't sound as if much is known about these cases.

But that's beside the point Tamiflu basically will shorten your syptoms for about a day. Personally I wouldn't bother with it. My father however has a serious respiritory condition and I'd really suggest that he were to take it.

All drugs carry a risk - Nobody in government is forcing anyone to take it but they've acted quickly to make sure that it's available. If they sat back and hadn't there'd've been war.

Talk about damned if you do and damned if you don't.

Would you rather they sent everyone a leaflet entitled "Swine Flu - How to pull yourself together and snap out of it"?
Squad - you said to me

"Children can and should be prescribed Tamiflu"

Do you remember?
jake...I do and subsequent events have proved me wrong, which often happens in Medicine.
jake...."otherwise healthy children" means that they do not have a pre-existing condition.
I'm not sure if they're saying anything so emphatic as it isn't safe - I think it's more like Sqad says: it's probably (not certainly) not effective and there are side-effects, so parents might well feel happier not giving it to their kids.

http://www.guardian.co.uk/world/2009/aug/11/sw ine-flu-tamiflu-andrew-castle

There would rpobably be protests if the government just shrugged and said there were no suitable drugs available. At least this way parents can make up their own minds.
Sqad

"jake...I do and subsequent events have proved me wrong, which often happens in Medicine"

So does your advice to me to have the amputation still hold?
jno....LOL...you haven't had it have you?
I could always grow another one, couldn't I?
Events prove people wrong - exactly

So why is Gromit trying to make this look like as issue of trust in Government?

They've clearly acted speedily with the best evidence available at the time.

We seem to know very little about these cases right now - they may have contracted a different disease, a mutated strain there could even have been a bad batch or even a fake batch of drugs.

We just don't know

So let's not jump to the nearest available conclusion eh?

Question Author
Jake,

The debate about the safety of tamiflu has been around for quite a while.
This is from 2005

http://www.independent.co.uk/news/world/americ as/us-reviews-risks-of-tamiflu-after-12-childr en-die-515789.html

Rather that asking a question about trust, I was more asking whether its safety and effectiveness and value for money were properly assessed before the expenditure of�200million was made?
Gromit - No evidence of causality exists between the deaths of 12 youngsters in Japan and Tamiflu after exhaustive examination of the data both in Japan and by the FDA in the USA - All had received Oseltamivir, true, but they all suffered from 'flu as well, and influenza- related neuropathy has been well documented in children.

There has been extensive surveillance of tamiflu - over 50 million doses have been given, and the ADRs are at a level of around 1%, ranging in severity from the most minor of reactions through to the more severe.

The calculation must be the effectiveness Oseltamivir in inhibiting the spread of a virus and its small treatment effect in infection vs the pathogenicity of the virus itself.

Remember that tamiflu was bought as a first line of defence against any pandemic influenza virus, most particularly the Avian Flu Virus which has demonstrated a frightening pathogenicity. In that context, the Government were unequivocally right in buying Oseltamivir stocks and should be commended for their planning.

After the initial panic over H1N1 ( remember the initial results in Mexico, which showed a more infectious virus than avian flu, but seemingly just as deadly), and our own early experience of its spread, It was perhaps understandable that tamiflu was made so widely and easily available - That decision might be questioned in light of what we now know about the low pathogenicity - but just imagine the level of hysteria had we not had the antivirals available.

Personally, I think that since H1N1 in this incarnation has demonstrated very mild clinical effects, Tamiflu probably shouldn't be prescribed to 12s and under.

I don't understand objections to a vaccine though... I will definitely be in the queue when it is available. H1N1 vaccine is as well tested as the seasonal flu vaccines that are administered every year.
Lazy gun.

I have read your well presented reply and bye and large agree with your comments..BUT

No evidence of causality exists between the deaths of 12 youngsters in Japan and Tamiflu after exhaustive examination of the data both in Japan and by the FDA in the USA

Very difficult to explain 4 sudden deaths, heart attack, 2 suicides, pneumonia and acute pancreatits and multiple psychiatric problems in children.

Could be coincidence, could be secondary to H1N1, could be due to Tamiflu.

Lazygun, I don�t think that the FDA did say that there was no causal link between Tamiflu and the reported deaths from Japan�.what it did say was:

One question they will have to address is how to distinguish the effects of the drug from the effects of the flu.

Something quite different from denying a causal relationship.

In my opinion there is an issue with Tamiflu and its alleged side effects which has to be addressed considering the minimal benefit in the pathogenesis of H1N1

At this moment I would withhold Tamiflu from children until the causality is ruled out.

If there is a reference stating no definite link to Tamiflu of the above, then clearly I apologise.
Lazygun...the vaccine.

Concerning vaccinations.

I am not a pure scientist, but I am concerned about the following:

Providing that H1N1 does not change it�s antigenic structure, then a vaccine has been developed and properly conducted clinical trials have been set up and the results reviewed in 5 months. My gut reaction is that this is a very short period of time to circulate and vaccinate a population that will mainly include children and young adults.
This time span may be perfectly acceptable and reasonable for the scientific virologists.

An unexplained increase in the risk of Guillain-Barr� syndrome (GBS) occurred among recipients of the swine influenza vaccine in 1976-1977. Guillain-Barr� syndrome remains the most frequent neurological condition reported after influenza vaccination to the Vaccine Adverse Events Reporting System (VAERS) since its inception in 1990.
From 1990 to 2003, VAERS reporting rates of GBS after influenza vaccination decreased. The long onset interval and low prevalence of other preexisting illnesses are consistent with a possible causal association between GBS and influenza vaccine. These findings require additional research, which can lead to a fuller understanding of the causes of GBS and its possible relationship with influenza vaccine.
That was the situation about 5yrs ago and I haven�t seen an update, but if you have one to hand I would be appreciative.
H1N1 is mild in the elderly and myself will not take the vaccine��.although I can quite understand the objection to this.

Vaccination of children worries me.

If the virus mutates then we are in a different �ball game�

Hi Sqad - As you point out, it 's very difficult to explain the mortality specifically in those cases mentioned - but my reading of the FDA report was that it was not possible to attribute causality to oseltamivir - balance of probabilities suggested that neuropathology of the viral infection, or purely temporal causes were far more likely culprits.

The 1976 outbreak of swine flu in the USA and the numbers of GBS cases is probably the single strongest causal relationship yet between a mass vaccination programme and immunopathology, and even now no one has a clear idea why.If memory serves, there were 500 cases of GBS registered, out of 25% of the US population vaccinated, representing a significant increase in cases of GBS reported. Nothing like it has been seen since.

Subsequent evidential review of the data through the VAERS programme show that GBS remains an extremely rare complication of a mass influenza vaccination programme, approximately a 1 in a million event - so if everyone in the UK was vaccinated, you might expect to see perhaps 60 cases.

You have to balance the risk of serious illness and mortality from the virus against the very rare complications of the vaccine programme, and for me the evidence in favour of vaccine efficacy and safety is compelling.

Long post - ctd -
ctd from previous post -

I do understand where you are coming from - Since swine flu so far has proven pretty mild, would it be worth getting vaccinated? The fear that the vaccine might mutate into something more pathological is a valid one, and indeed the vaccine in its current form may not be protective - But we would be extremely unlucky if the mutation rendered the vaccine ineffective. In these circumstances, I would still get the vaccination, and would vaccinate my kids, were they still at home and subject to my control ! :)

Finally, I dont have any substantive new reports or data to show you sqad, but I have provided a link to a couple of abstracts - you may or may not have seen them.

http://www.ncbi.nlm.nih.gov/pubmed/19388722
http://www.ncbi.nlm.nih.gov/pubmed/15562126?or dinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed. Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubm ed_Discovery_RA&linkpos=1&log$=relatedarticles &logdbfrom=pubmed
lazy...thanks again for an informed answer........hope that you are right............and anyway, I am an old cynic.LOL

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