Tamiflu has no effect on kids with H1N1: study

[vinny]

Flu drugs 'unhelpful' in children

Tamiflu is the antiviral being used in the UK

The antiviral drugs being used to treat swine flu do not appear to work well in children, say UK researchers.

Their work in the British Medical Journal shows Tamiflu and Relenza rarely prevent complications in children who have normal seasonal flu.

Although it is hard to generalise this to the current swine flu pandemic, they say these drugs are unlikely to help children who catch the H1N1 virus.

Side effects and the risk of resistance developing may negate their use.

There were an estimated 30,000 new cases of swine flu in England in the last week, a drop compared with the 110,000 cases the week before.

Our research is finding for most children these antiviral drugs are probably not going to have much of an effect

Study author Dr Matthew Thompson
A decreased incidence has also been seen in Scotland and Wales in the past week.

The total of swine flu-related deaths in England and Scotland stands at 40.

Antivirals are the mainstay of treatment at the moment until a vaccine becomes available, which is expected in September.

The drugs are designed to ensure that symptoms are mild and reduce the chance of an infected person giving the illness to someone else.

The UK has moved beyond the stage of containing swine flu into the "treatment phase", which means that Tamiflu is only being offered to people who have swine flu and not usually to their contacts.

No effect

While the latest study shows that antivirals can shorten the duration of flu in children by up to a day and a half, it also shows that they have little or no effect on asthma flare-ups, ear infections or the likelihood of children needing antibiotics.

The antiviral Tamiflu is also linked to an increased risk of vomiting.

The study also reveals the effectiveness of using antivirals to contain the spread of flu.

They found that 13 people need to be treated to prevent one additional case, meaning antivirals reduce transmission by 8%.

The University of Oxford team, led by Dr Matthew Thompson, carried out a review of four trials on the treatment of seasonal flu in 1,766 children and three trials involving the use of antiviral to limit the spread of seasonal flu in 863 children.

Dr Thompson said: "Our research is finding for most children these antiviral drugs are probably not going to have much of an effect."

Co-researcher Dr Carl Henegan, a GP and expert from the John Radcliffe Hospital in Oxford, said the current policy of giving Tamiflu for mild illness was an "inappropriate strategy".

He said: "The downside of the harms outweigh the one-day reduction in symptomatic benefits."

http://news.bbc.co.uk/1/hi/health/8193012.stm

[GennieF]

Tamiflu has no effect on kids with H1N1: study

Monday,10 August 2009 20:23 hrs IST
Tamiflu has no effect on kids with H1N1: study

London: In new research with implications for swine flu treatment in India, experts based at the University of Oxford say that antivirals oseltamivir (Tamiflu) and zanamivir (Relenza) are unlikely to prevent complications in children who have swine flu. While the study published in the British Medical Journal shows that antivirals shorten the duration of flu in children by up to a day and a half, it also shows that they have little or no effect on asthma flare-ups, increased ear infections or the likelihood of children needing antibiotics.

The antiviral Tamiflu is also linked to an increased risk of vomiting.

The authors, led by Dr Matthew Thompson from the University of Oxford, add that the study reveals the effectiveness of using antivirals to contain the spread of flu.

They conclude that 13 people need to be treated to prevent one additional case; therefore antivirals reduce transmission by 8 per cent. During seasonal flu epidemics children are at high risk, with over 4 in 10 (40 per cent) pre-school children getting the virus and 3 in 10 (30 per cent) school age children doing so.

School age children are also the main source of spread of flu into households, say the authors.

The main strategy to control flu is vaccination but coverage can be low and often there is not enough time to produce and distribute vaccines in response to emerging strains.

http://week.manoramaonline.com/cgi-bin/MMOnline.dll/portal/ep/contentView.do?contentId=5825388&programId=1073754912&pageTypeId=1073754893&contentType=EDITORIAL

[Shannon Bennett]

Re: Tamiflu has no effect on kids with H1N1: study

I wonder if it helped prevent cytokinesis? Or, were none of the cases studied that severe?

[Snowy Owl]

Re: Tamiflu has no effect on kids with H1N1: study

WOW,

I have to land here, because the title of this thread is misleading, false and dangerous.

From Voice of America

http://www.voanews.com/english/archive/2005-11/2005-11-13-voa12.cfm?CFID=266465134&CFTOKEN=73115362&jsessionid=843041b9c73247ba20c2314632786c7c5e63

Japan Links Tamiflu to Sudden Deaths in Children

Tokyo
13 November 2005

Herman report - Download 445k - Download (Real)
Herman report - Download 445k - Listen (Real)

Tamiflu

Japan's health ministry says it plans to reissue a warning of dangerous behavioral side effects linked to the anti-influenza drug Tamiflu.

This comes amid reports that several children in Japan died after taking the medication. Governments around the world are stockpiling the medicine amid growing fears of a possible human pandemic of avian influenza.

Japan's health ministry says it is looking into reports of a number of sudden deaths of young people who had taken prescribed dosages of Tamiflu.

The ministry confirms that it has concluded that the death of one boy was the result of side effects from the drug. The ministry says it has found 64 cases of psychological disorders linked to the drug in the past four years.

Dr. Rokuro Hama, head of the Japan Institute of Pharmaco-Vigilance, says he has investigated eight suspicious deaths of children aged between two and 17 over the past three years, which he thinks are linked to Tamiflu. He reported his findings Saturday at a meeting of the Japan Society of Pediatric Infectious Diseases.

Dr. Hama said Sunday that Tamiflu appears to be similar to other powerful drugs that can cause behavioral changes.

"These are tranquilizers, sedatives or hypnotics. These cause discontrol or disregulation of the central nervous system. So it may cause very bizarre phenomenon or behavior," said Dr. Hama.

Investigators say in one case last year, a 17-year-old boy, after taking the medication, left his home during a snowstorm, and jumped in front of a truck and died.

Earlier this year, a 14-year-old boy, after taking one Tamiflu capsule, jumped or fell from the ninth floor of an apartment building.

Doctors say in both cases the boys had not exhibited any abnormal behavior before taking Tamiflu.

Yuji Yamashita of Chugai Pharmaceutical, the Japanese distributor for Tamiflu, said Sunday that the company had notified the health ministry about two deaths involving teenage boys. However, Mr. Yamashita said he had no knowledge of any other cases of psychological side effects the ministry has tracked.

Tamiflu, which has the generic name of oseltamivir phosphate, is produced by Roche, based in Switzerland. The medication inhibits the growth of flu virus in humans.

In Japan, the medication comes with a warning alerting patients to the possibility of impaired consciousness, abnormal behavior, hallucinations, and other psychological and neurological symptoms.

But Dr. Hama at the Institute of Pharmaco-Vigilance says because Tamiflu is a new drug, most health care professionals wrongly conclude behavioral changes are the result of delirium caused by high fever.

Dr. Hama says the health ministry's initial alert last year received little notice, even among medical professionals.

"It was not reported, distributed through the mass media, so doctors do not notice that warning," he said.

In other countries, including the United States, there is no such explicit warning with the medication.

Roche, in its consumer information, says there have been cases of seizures and confusion in patients who have taken Tamiflu but, as with a number of other side effects, "it is not possible to reliably estimate their frequency or establish a causal relationship to Tamiflu exposure."

Roche officials at its headquarters in Switzerland and the United States were not available Sunday to comment directly on the new warning from Japan.

However, a company statement issued Sunday said Tamiflu has been shown to have a "good safety profile". Roche says it monitors reports of side effects but says they must be considered in the context of flu symptoms, which includes high fevers that can lead to neurological complications.

Japan, like many other nations, is boosting its stockpile of Tamiflu, in case there is a flu pandemic in the next few years. The government is trying to acquire 250 million capsules to cover treatment for 25 million people.

Sorry Mr. Rumsfeld of Gilead but it is becoming a known fact that Tamiflu in children cause nightmares and psycological problems.

You have to cope with that Sir.

Snowy

[GennieF]

Don't give swine flu drugs to under-12s, says study

Don't give swine flu drugs to under-12s, says study

? Side-effects said to outweigh benefits
? Government queries relevance of research

James Sturcke
guardian.co.uk, Monday 10 August 2009 20.33 BST

Children under the age of 12 should not be given Tamiflu or Relenza, the two antiviral drugs that form the cornerstone of the government's fight against swine flu, because their side-effects outweigh any benefits, Oxford University researchers said yesterday.

A study by Dr Matthew Thompson, a clinical scientist, and Dr Carl Heneghan, a clinical lecturer, found that antivirals were no "magic bullet" and only led to a minor reduction in the length of time that a child with mild sickness was ill or the chance of their spreading the disease.

The research, to be published in the British Medical Journal, said that Tamiflu caused vomiting in 5% of children, which could lead to dehydration and complications.

The Oxford researchers, both GPs, said children with mild symptoms should be treated in the same way as if they had any other mild flu ? with drinks to cool high temperatures and rest ? and there was no need for children who were otherwise healthy to be taking Tamiflu or Relenza. They called on the government to be clear about the limitations of the two drugs.

"It would be quite reasonable for the Department of Health to make clear to parents and GPs how much help the drugs are," Thompson told a press conference.

The research, a peer review of seven trials, all but one previously published, looked at the effectiveness of antivirals in reducing seasonal flu complications and stopping the spread of the disease. They said their findings were relevant to the current swine flu outbreak because the diseases shared many characteristics.

They found the drugs had little or no effect on asthma flare-ups, ear infections or the likelihood of a youngster needing antibiotics.

The researchers also found that preventive antiviral use had little effect, reducing transmission of flu by 8%. Thirteen children would have to be treated to prevent one additional case of the flu, they said. The benefit of antivirals was that they reduced symptoms.

Heneghan said the current policy of giving Tamiflu for mild illness was an "inappropriate strategy".

"The downside of the harms outweighs the one-day reduction in symptomatic benefits," Heneghan said.

His advice to GPs was "not to rely on Tamiflu as a treatment to reduce complications" or to think of it as a "magic bullet".

He likened the current policy, which saw more than 315,000 courses of antivirals given out during the first two weeks the national pandemic flu line was in operation, to misguided historical health policies such as the prescription of antibiotics for sore throats.

"The problem is a resistance issue," said Heneghan. "Going forward we have a treatment which is ineffective because we've given it to everybody. We are calling for a more rational prescription process for these drugs."

One of the country's most respected flu experts, Professor Hugh Pennington, agreed that reliance on antivirals was increasing the possibility that the flu would become resistant sooner or later.

"We cannot be certain that the virus will not get nastier. We might require antivirals for the elderly or others who are more likely to get complications. It means the potential that a resistant strain will get that selective advantage as it will grow in a Tamiflu environment."

Norman Lamb, the Liberal Democrat health spokesman, said: "The government antiviral policy and flu line need to be kept under constant review. The cost involved is very high. Perhaps it should come down and be relaunched in the autumn. These are judgments for the chief medical officer."

The Department of Health disputed the relevance of a seasonal flu study to the current outbreak. "The extent to which the findings can be applied to the current pandemic is questionable ? after all, we already know that swine flu behaves differently to seasonal flu, and past pandemics have hit younger people hardest. Whilst there is doubt about how swine flu affects children, we believe a safety-first approach of offering antivirals to everyone remains a sensible and responsible way forward. However, we will keep this policy under review as we learn more about the virus and its effects."

Roche, which makes Tamiflu, said: "Health authorities worldwide such as the National Institute for Health and Clinical Excellence (Nice), European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have reviewed the data from controlled clinical trials and approved Tamiflu (oseltamivir) for use in children based upon a positive benefit/risk assessment.

"There are significant data showing the medicine to be effective and well tolerated when used for the treatment or prevention of influenza in children."

http://www.guardian.co.uk/world/2009/aug/10/swine-flu-drugs-under-12s

[Desolation_anonymous]

Re: Don't give swine flu drugs to under-12s, says study

Don't give swine flu drugs to under-12s, says study

? Side-effects said to outweigh benefits
? Government queries relevance of research

James Sturcke
guardian.co.uk, Monday 10 August 2009 20.33 BST

Children under the age of 12 should not be given Tamiflu or Relenza, the two antiviral drugs that form the cornerstone of the government's fight against swine flu, because their side-effects outweigh any benefits, Oxford University researchers said yesterday.

A study by Dr Matthew Thompson, a clinical scientist, and Dr Carl Heneghan, a clinical lecturer, found that antivirals were no "magic bullet" and only led to a minor reduction in the length of time that a child with mild sickness was ill or the chance of their spreading the disease.

The research, to be published in the British Medical Journal, said that Tamiflu caused vomiting in 5% of children, which could lead to dehydration and complications.

The Oxford researchers, both GPs, said children with mild symptoms should be treated in the same way as if they had any other mild flu ? with drinks to cool high temperatures and rest ? and there was no need for children who were otherwise healthy to be taking Tamiflu or Relenza. They called on the government to be clear about the limitations of the two drugs.

"It would be quite reasonable for the Department of Health to make clear to parents and GPs how much help the drugs are," Thompson told a press conference.

The research, a peer review of seven trials, all but one previously published, looked at the effectiveness of antivirals in reducing seasonal flu complications and stopping the spread of the disease. They said their findings were relevant to the current swine flu outbreak because the diseases shared many characteristics.

They found the drugs had little or no effect on asthma flare-ups, ear infections or the likelihood of a youngster needing antibiotics.

The researchers also found that preventive antiviral use had little effect, reducing transmission of flu by 8%. Thirteen children would have to be treated to prevent one additional case of the flu, they said. The benefit of antivirals was that they reduced symptoms.

Heneghan said the current policy of giving Tamiflu for mild illness was an "inappropriate strategy".

"The downside of the harms outweighs the one-day reduction in symptomatic benefits," Heneghan said.

His advice to GPs was "not to rely on Tamiflu as a treatment to reduce complications" or to think of it as a "magic bullet".

He likened the current policy, which saw more than 315,000 courses of antivirals given out during the first two weeks the national pandemic flu line was in operation, to misguided historical health policies such as the prescription of antibiotics for sore throats.

"The problem is a resistance issue," said Heneghan. "Going forward we have a treatment which is ineffective because we've given it to everybody. We are calling for a more rational prescription process for these drugs."

One of the country's most respected flu experts, Professor Hugh Pennington, agreed that reliance on antivirals was increasing the possibility that the flu would become resistant sooner or later.

"We cannot be certain that the virus will not get nastier. We might require antivirals for the elderly or others who are more likely to get complications. It means the potential that a resistant strain will get that selective advantage as it will grow in a Tamiflu environment."

Norman Lamb, the Liberal Democrat health spokesman, said: "The government antiviral policy and flu line need to be kept under constant review. The cost involved is very high. Perhaps it should come down and be relaunched in the autumn. These are judgments for the chief medical officer."

The Department of Health disputed the relevance of a seasonal flu study to the current outbreak. "The extent to which the findings can be applied to the current pandemic is questionable ? after all, we already know that swine flu behaves differently to seasonal flu, and past pandemics have hit younger people hardest. Whilst there is doubt about how swine flu affects children, we believe a safety-first approach of offering antivirals to everyone remains a sensible and responsible way forward. However, we will keep this policy under review as we learn more about the virus and its effects."

Roche, which makes Tamiflu, said: "Health authorities worldwide such as the National Institute for Health and Clinical Excellence (Nice), European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have reviewed the data from controlled clinical trials and approved Tamiflu (oseltamivir) for use in children based upon a positive benefit/risk assessment.

"There are significant data showing the medicine to be effective and well tolerated when used for the treatment or prevention of influenza in children."

http://www.guardian.co.uk/world/2009...rugs-under-12s

Hmmm.. This scares me a bit, as both of my babies are on Tamiflu due to having the flu, most likely H1N1, and asthma.

baby 1 has had some asthma flare-ups, but so *far* (day 4 of illness) it has not gotten as bad as when he had RSV at 3 months old.

Baby 2- not as far in disease. Fever did not seem to get as bad as baby 1.

I don't know about complications, but it did seem to help with baby 1 fever and amount of pain/misery within 24 hours of taking.

I don't know about other parents, but for me- having a limp baby burning with fever whimpering with pain in your arms, especially if your child is high-risk and have has asthma, a reduction in symptoms is relevent.

[dr kockosh]

Re: Tamiflu has no effect on kids with H1N1: study

looks like new second generation neuradimase inhibitors more effective for kids and well tollerated according to research released yesterday.



announcement from japan

Positive top line results from Phase III study (MARVEL) of anti-influenza virus
agent ?CS-8958?

TOKYO, Japan (August 10, 2009)

�� Daiichi Sankyo Company, Limited announced
today the top line results from a Phase III study of the anti-influenza virus agent ?CS-8958?
(generic name; laninamivir).
This study, named MARVEL (Multinational Asian Clinical Research for Influenza Virus
Extermination on Long-Acting Neuraminidase-Inhibitor study), was performed as a randomized,
double-blind, and active-controlled study in order to confirm the efficacy and safety of CS-8958
administered as a single inhaled dose of 20 or 40 mg compared to oseltamivir phosphate 75 mg
(Tamiflu�� capsule) orally administered twice daily for 5 days (total of 10 times) in adult
patients with influenza A or B virus infection. According to the results, non-inferiority to
oseltamivir phosphate was confirmed in both the 20 mg group and 40 mg group of CS-8958 in
terms of the primary endpoint, which was the time to alleviation of influenza illness. In the
comparison between the dose groups of CS-8958, 40 mg group was superior to 20 mg group in
efficacy. Both 20 mg and 40 mg of CS-8958 were well tolerated.
In addition, Daiichi Sankyo conducted a randomized, double-blind, active-controlled Phase
II/III study for pediatric use in parallel with MARVEL study, and the efficacy and safety of
CS-8958 administered as a single inhaled dose of 20 or 40 mg was compared to oseltamivir
phosphate (Tamiflu�� for oral suspension) as well. According to the results, both the 20 mg
group and 40 mg group of CS-8958 were better than oseltamivir phosphate group in efficacy.
Both 20 mg and 40 mg of CS-8958 were well tolerated in pediatric patients.
Daiichi Sankyo is now preparing to file its NDA for a treatment indication in fiscal year 2009.
Furthermore, Daiichi Sankyo is also preparing to start a clinical study for a prophylaxis
indication in autumn of 2009.

��

About CS-8958
CS-8958 (generic name; laninamivir) is an anti-influenza virus agent, originated by Daiichi
Sankyo Co.,Ltd., and is expected to be effective after a single dose due to its long action as a
neuraminidase inhibitor. After inhalation, CS-8958 is retained for a long time in the target organ.
Non-clinical studies conducted so far have shown that this agent was effective not only against
seasonal influenza, but also against new type influenza (swine A/H1N1) in-vitro and in-vivo (Y.
Itoh,et al, Nature, 2009). Additionally, CS-8958 shows efficacy against H5N1 avian influenza

virus in non-clinical tests.

<!-- / message -->

<!-- controls -->

[dr kockosh]

Re: Tamiflu has no effect on kids with H1N1: study

The company (australias Biota) said that the drug, taken via inhalation, differed from other flu drugs in that it required just one dose to treat flu and a once-weekly dose to prevent flu.

But, he said, (biota ceo)in the event of a "turn for the worst" in the incidence of swine flu, the US Food and Drug Administration may accept the studies done elsewhere in the world (Japan)for approval under emergency circumstances.

In my opinion This is a very important find as it not only gives a new generation of anti- viral right when we are heading for an unknown potentially lethal flu period - but also one that is safe and more effective in children - looks like there is some potential to get early registration under emergency act and i believe there is an advantage in production storage etc because you only need one dose - this would make it cheaper to produce store and ship - under the circumstances this should be put into emergency production by WHO collaboration.

<!-- / message -->

<!-- / message -->

[kiwibird]

Re: Tamiflu has no effect on kids with H1N1: study

I think this story may have more to do with this thread:

http://www.flutrackers.com/forum/showthread.php?t=114394&highlight=stockpile+tamiflu

LONDON (AP) ? Britain's health minister says the country faces a projected 100,000 new swine flu cases a day by August and must revamp its flu strategy.
Britain had been trying to contain the disease by liberally giving out the drug Tamiflu to all suspected swine flu cases and their contacts.
Health minister Andy Burnham said Thursday that Britain will now only give the antiviral to people with the virus. (...)
Burnham announced in the House of Commons Thursday that Britain was going to stop liberally giving out Tamiflu to all cases and their contacts, and that the antiviral would only be used to treat patients. Many experts have criticized Britain's approach to the outbreak for wasting resources and drugs.

The UK INFLUENZA PANDEMIC CONTINGENCY PLAN started on October 2005. From October 2005 to January 2009, the UK stockpile for Tamiflu was brought up from 2.5 millions to at least 14.6 millions of treatment course. 14.6 millions is enough for TREATMENT of 24 percent of the UK population (60.8 million). There had been a stepwise announcement of UK Health Authorities to bring up Tamiflu stockpile to about 30 millions (to treat 50% of the British population; November 2007) and at last to about 50 millions doses of treatment course (April 2009).

But in January 2009 due to the parliament publication as quoted above, the mass of 11 billions of milligrammes Oseltamivir (Tamiflu) had only been the stockpile for 14.6 millions of treatment course (11 billions mg divided by 750 mg).

If it was true, that UK Tamiflu stockpile was brought up to 50 millions of treatment course in April 2009, it then would be the mass of 37.5 billions of milligrammes. That stockpile then truly would be enough for the TREATMENT (not only prophylaxes) of 82 percent of the UK population (50/60.8 millions).

In 2004 there were 7.4 million families with 13.1 million dependent children living in them in the UK.

http://www.statistics.gov.uk/cci/nugget.asp?id=1163

I would think that it was not "liberal" to provide anti-virals to an at risk group. I note that when Mrs Blair, former Prime Ministers wife, caught the flu she was instantly given Tamiflu. Perhaps the government should be giving vulnerable children Relenza if they do not react well to Tamiflu.

But the UK really is one of the best prepared countries (36 % for Tamiflu alone and 53 % for both Tamiflu and Relenza)

http://www.flutrackers.com/forum/sho...ckpile+tamiflu

[dr kockosh]

Re: Tamiflu has no effect on kids with H1N1: study

yes i agree - and if you look at the study tamiflu appears to increase vomiting in children - so how much is absorbed any way - in addition with this new swine flu stain vomiting and diahr are common and infection deep in the lung more so than seasonal flu - so makes sense to administer relenza direct to lung - gets there more quickly - no gi absorption requierd + time lag while absorption takes place if at all.

even better biotas LANI - one puff supervised by Dr or nurse or at home - job done
less room for error -particially with kids stays in target zone for full seven days and better tollerated - no side effects reported- i hear japanese will fast track registration - i hope they fast track LANI for western world before more serious mutation arrives - otherwise we'll be left with only relenza. tamiflu will be useless - i agree with dr niman on that -