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A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases
Date: Mon 10 Aug 2009
Source: The Daily Telegraph online [edited]
[NB: This analysis refers to the use of oseltamivir [Tamiflu] in children
exposed to seasonal influenza virus infection but is included in the
influenza pandemic (H1N1) thread because of its relevance to the current
practice regarding the use of neuraminidase inhibitors in the treatment of
children exposed or potentially exposed to pandemic flu. - Mod.CP]
Children should not be given the antiviral drug Tamiflu [oseltamivir] for
swine flu [influenza pandemic (H1N1) 2009 virus infection] because its
harms outweigh any benefits, and the government should review its policy on
dealing with the pandemic, researchers have said.
The antiviral drugs Tamiflu and Relenza [zanamivir] reduce the length of
time children are ill with flu by about one day and can cause vomiting as a
common side effect, Oxford researchers found. Vomiting is more dangerous in
children than in adults, as it can rapidly lead to dehydration and
admission to hospital, they said.
Also, the drugs had little or no effect on asthma flare-ups, ear infections
or the likelihood of a child needing antibiotics, meaning on balance the
medicine does more harm than good in otherwise healthy children, the
authors said. It comes after research last week showed that Tamiflu reduced
the length of flu in adults by just half a day.
Together, these findings will question whether the government's policy of
stockpiling enough antiviral drugs for 80 per cent of the population was a
waste of money. The exact cost of the stockpile has been kept secret for
"commercial reasons" but is expected to run to tens of millions of pounds.
Countries around the world have stockpiled around 50 million doses of
Tamiflu, made by Roche, for use during a flu pandemic.
Tamiflu has also been linked to side effects such as insomnia and
nightmares in children. Dr Matthew Thompson, a GP and senior clinical
scientist at Oxford University and Dr Carl Heneghan, a clinical lecturer at
Oxford University, said the findings review of 7 research studies should
prompt the Department of Health to reconsider its policy. The study,
published online in the British Medical Journal, reviewed trials where
children aged between one and 12 were either given Relenza or Tamiflu to
treat seasonal flu or where one of their family had flu and they were given
medicine to stop them becoming ill. The researchers said although the
studies were carried out on seasonal flu, the findings are relevant to the
current swine flu outbreak.
The drugs may still be of some benefit for children who have underlying
conditions such as cystic fibrosis or whose immune system is compromised
because they are being treated for leukaemia, for example, but there was
not enough evidence to be conclusive about this, the researchers said. Dr
Thompson said the government's current policy of giving Tamiflu to all
symptomatic people was "inappropriate."
GPs are using their clinical judgment and providing antivirals to severe
cases of flu, but the National Pandemic Flu Service is handing out the
drugs to anyone who fits the criteria for having a flu-like illness. Data
from the Health Protection Agency has suggested only one in 4 of those with
symptoms will actually have swine flu.
The Flu Service handed out 150 000 doses of Tamiflu in its 1st week as
cases peaked at around 110 000 in 7 days. Dr Thompson said: "Reserving
these antiviral drugs for children who are more likely to have
complications may be a more sensible strategy and would take some of the
pressure off the current public demand for antivirals." Dr Heneghan warned
that prescribing the drugs so widely will encourage flu to become resistant
to the medicine. He said: "Going forward, we have a treatment which is
ineffective because we've given it to everybody." He also warned that
people were relying on Tamiflu, also known as oseltamivir, "like a magic
bullet," and this meant that serious complications of swine flu could be
dismissed in those on the drug. Parents should treat flu in children with
paracetamol and rest but watch carefully for complications and contact
their GP if they are worried, the authors said.
The research trials which were reviewed have been available for over a
year, and the government could have carried out its own study in this
before the outbreak of swine flu began, they said. The findings also showed
that when using antiviral drugs in children who have been exposed to flu
but do not yet have symptoms, as preventive treatment, they were of limited
use. They found 13 children need to be treated to prevent one case, meaning
onward transmission was only reduced by 8 per cent.
Government data released on 30 Jul 2009 suggested that by then, one in 77
children aged between one and 4 had already had swine flu along with one in
95 of those aged between 4 and 14.
Norman Lamb, Liberal Democrat health spokesman said: "An urgent review must
be carried out into whether the benefits of prescribing certain antiviral
drugs are worth the risks when it comes to our children's health. "Parents
will now need urgent guidance and reassurance about what exactly they
should be doing to look after their children. This is even more crucial
given that health experts are predicting a surge in swine flu cases this
autumn [2009]."
Sir Liam Donaldson, the government's chief medical advisor, said: "This is
a good research team, and their report is welcome. However, the study is
limited in its scope, tentative in its conclusions and not directly
comparable to the current situation. It reviewed a very small number of
past clinical trials on seasonal flu, not the current H1N1 pandemic flu
strain. Antivirals are the only available weapon, albeit imperfect, against
the virus until a vaccine is developed and ready for use. Like all drugs,
they can have side effects in some people."
A Department of Health spokesman said: "The BMJ review is based on seasonal
flu and not swine flu. As the authors note, 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. For those who experience severe symptoms,
the best scientific advice tells us that Tamiflu should still be taken as
soon as possible; and to suggest otherwise is potentially dangerous. If
people are in any doubt about whether to take Tamiflu, they should contact
their GP."
A spokesman for Roche, which makes Tamiflu, said: "Data ... show that in
otherwise healthy children (under 12s) who had fever plus either cough or
head cold symptoms, Tamiflu treatment, started within 48 hours of onset of
symptoms, significantly reduces the time to alleviation on illness by 1.5
days compared to placebo. As with all medicines, healthcare professionals
need to weigh up the benefits against the risk of any side effects."
The latest figures have suggested the 1st wave of the swine flu outbreak
has peaked [in the UK], with officials saying around 30 000 new cases were
diagnosed in the week ending 1 Aug 2009, but a 2nd wave is still expected
later in the autumn. So far, 36 people with swine flu [in the UK] have died.
[byline: Rebecca Smith]
--
communicated by:
ProMED-mail rapporteur Mary Marshall
[The reference for the BMJ article is: Matthew Shun-Shin, Matthew Thompson,
Carl Heneghan, Rafael Perera, Anthony Harnden, and David Mant.
Neuraminidase inhibitors for treatment and prophylaxis of influenza in
children: systematic review and meta-analysis of randomised controlled
trials BMJ 2009;339:b3172, doi: 10.1136/bmj.b3172 (Published 10 Aug 2009)
Mod.CP]
[see also:
Influenza pandemic (H1N1) 2009 (27): Viet Nam, patient data update
20090809.2819
Influenza pandemic (H1N1) 2009 (26): update 20090807.2801
Influenza pandemic (H1N1) 2009 (25): Australia, UK, updates 20090806.2784
Influenza pandemic (H1N1) 2009 (24): global update 20090805.2766
Influenza pandemic (H1N1) 2009 (23): (China, Taiwan), co-circ. H3N2
20090802.2713
Influenza pandemic (H1N1) 2009 (22): Australia (NSW), swine 20090801.2698
Influenza pandemic (H1N1) 2009 (21): vaccine priorities 20090730.2669
Influenza pandemic (H1N1) 2009 (20): Peru, 33 percent asymptomatic
20090730.2668
Influenza pandemic (H1N1) 2009 (10): vaccine 20090720.2577
Influenza pandemic (H1N1) 2009 (08): pandemic origins 20090718.2559
Influenza pandemic (H1N1) 2009 (06): case reporting 20090717.2553
Influenza pandemic (H1N1) 2009 (05): vaccine 20090716.2540
Influenza pandemic (H1N1) 2009 (04): pandemic origins 20090715.2527
Influenza pandemic (H1N1) 2009 (03): vaccine 20090713.2505
Influenza pandemic (H1N1) 2009 (02): obesity risk factor 20090711.2482
Influenza pandemic (H1N1) 2009 - Viet Nam: patient data 20090708.2450]
....................cp/msp/sh
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