Wednesday, August 12, 2009

[UK] Alarm grows over Tamiflu for children:

Antivirals are being stockpiled in case of a mass flu outbreak. Picture: PA

Published Date: 12 August 2009

THE government last night attempted to calm the fears of worried parents by insisting that the anti-viral Tamiflu was an appropriate treatment for children with swine flu.

The Department of Health issued a statement underlining its confidence in the drug following a TV presenter's claim that his daughter "almost died" after taking Tamiflu and a watchdog reported a surge in the number of people suffering side-effects.

GMTV host Andrew Castle told Health Secretary Andy Burnham live on TV that daughter Georgina, 16, who suffers from asthma, had a "respiratory collapse" and "suffered very heavily" after being given Tamiflu, following an outbreak of swine flu at her school.

An uncomfortable Mr Burnham defended the government's policy, saying Tamiflu was "our only line of defence against this new virus".

He agreed that Georgina Castle's case would have been very worrying, but he stressed that advice to parents to treat swine flu with Tamiflu remained unchanged.

He said: "Swine flu is a new virus, it's early days and we're adopting very much a safety-first approach to tackling the illness. Tamiflu is our only, our main line of defence against this new virus right now."

The news followed a series of reports casting doubt on the efficacy of anti-viral drugs to children:

• On 31 July, two studies from the Health Protection Agency found a high proportion of schoolchildren reporting problems after taking anti-virals, including nausea, insomnia and nightmares.

• On Monday, an Oxford University study said children should not be given Tamiflu because its side-effects outweighed any benefits.

• Yesterday it emerged that more than 400 reports of Tamiflu side-effects, a third of which were in children, had been received since the start of the swine flu outbreak, according to the Medicines and Healthcare products Regulatory Agency (MHRA).

In a statement, the Department of Health said: "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." However, it also said people should not take Tamiflu if they did not have swine flu.

The MHRA figures, published yesterday, showed children accounted for more than a third of the 418 people reporting side- effects. More than a quarter were reported in the past week.

A total of 686 reactions were reported because some people had multiple side-effects. The MHRA said one death had been linked to Tamiflu.

Some 300,000 people in England have received courses of Tamiflu through the government's national pandemic flu service. The Scottish Government said figures were not yet available for Scotland.

A total of 85 five- to 14-year-olds were among those reporting side-effects, plus 61 one- to four-year-olds.

There have been 28 cases overall of side-effects involving the drug in Scotland, but it is not known whether the low number is linked to tighter control over dispensing north of the Border.

More than half the UK reports involved "gastrointestinal disorders", with vomiting the most common side-effect, being reported in 97 cases. There were also 35 reports of nausea and 21 of diarrhoea. Skin disorders accounted for 156 reports, and psychiatric disorders 85.

Tamiflu, which is made by Roche, has vomiting and nausea listed as its main side-effects on its packaging.

Clinical studies accepted by health bodies in the UK and worldwide show that the drug should not aggravate asthma.

A total of 4 per cent of children with asthma experienced worse asthmatic symptoms when taking the drug – the same proportion as in a group of asthmatic children taking a dummy drug.

A study of the side-effects of Tamiflu by Oxford University, published in the British Medical Journal, found it caused vomiting in some children, leading to dehydration and complications. However, the government said the research was into seasonal flu, not swine flu, which it said was "a very important distinction".

The government has 23 million treatments of Tamiflu and 10.5 million treatments of another anti-viral, Relenza.

Orders of Tamiflu have been placed to increase UK supplies to 50 million doses, enough to treat 80 per cent of the population.

Pregnant women should take Relenza, which is inhaled and helps reduce flu symptoms without affecting the baby.

Medical experts said swine flu rather than Tamiflu may have caused Georgina Castle to collapse, but warned that the impact of using the drug to treat the illness remained unclear. Hugh Pennington, a microbiologist and emeritus professor of bacteriology at Aberdeen University, said: "If there was a respiratory collapse, it would be surprising if it was from Tamiflu – it is more likely to be the virus. It is difficult to ascribe side-effects to the drug itself. Government policy (in England] is a free-for-all, which has never been done before.

"We are in a giant experiment on a huge scale. It would be very surprising if a small number of people did not have side-effects, some of them serious. However, Tamiflu has been used for quite a long time, such as in Japan, and I am not aware of concern over any particular side-effects."

A spokesman for the Department of Health said: "We are world leaders in monitoring side-effects of drugs precisely so that we can make sure they are safe and effective. Both Relenza and Tamiflu have been through rigorous safety and efficacy tests. They are effective against swine flu and help relieve the symptoms and length of infection.

As with many medicines, a small proportion of patients may experience some side-effects, and nausea is one of them. Side- effects are clearly indicated on patient information leaflets."

An MHRA spokesman said: "Tamiflu and Relenza are acceptably safe medicines and most people will not suffer any side-effects. The balance of risks and benefits for Tamiflu and Relenza remains positive."

A Scottish Government spokeswoman said: "The decision whether or not to prescribe a drug for a patient is always a matter for the clinical judgment of the prescriber.

"Doctors are free to exercise their clinical judgment in deciding who should receive anti-virals based on an individual's needs."

How the drug works and the side-effects

What is Tamiflu?

An antiviral medicine known as a "neuraminidase inhibitor" which prevents the spread of the influenza virus inside the body, helping to ease symptoms.

What are its most common side-effects?

Nausea, vomiting, diarrhoea, stomach ache and headache.

How can these be reduced?

By taking the drug with food. Side-effects also mostly occur only after the first dose and will usually stop as treatment continues.

Why do medicines have side-effects?

Any medicine may produce unwanted or unexpected adverse reactions, many of which are linked to the way they medicine work. However, different patients may respond in different ways to the same medicine.

What effect has Tamiflu on swine flu?

It is not a cure, but it can help recovery by relieving some the symptoms, cutting the length of illness by about a day and by reducing the potential for serious complications such as pneumonia. It will not change the effectiveness of a flu vaccine.

How can I get Tamiflu?

In Scotland, only through a GP. In England, it is available by phoning the government's national pandemic flu service

Which groups should take Tamiflu if they catch swine flu?

The government says anyone with severe symptoms should take it, but the at-risk groups are children under five, people aged 65+, those receiving drug treatment for asthma, people with chronic lung, heart, kidney, liver or neurological disease, those with immunosuppression, and diabetics.

What about pregnant women who catch swine flu?

They should take Relenza, another antiviral drug, which is inhaled and helps symptoms without affecting the baby. However, in severe swine flu cases, a doctor may prescribe Tamiflu.

What are the risks of such antiviral drugs to pregnant women?

An expert group has told the government the risk is extremely small – smaller than the risk posed by the symptoms of swine flu.

What are the side-effects of Relenza?

Wheezing or serious breathing problems, headaches, diarrhoea, nausea and vomiting.


WHILE fears are being raised about the side-effects of anti-viral drugs to treat swine flu, new controversy could emerge over the forthcoming vaccine for the virus.

The first supplies are due to arrive in Scotland this month, but the Scottish Government does not now expect to make it available until "the autumn". Doctors believe vaccinations will start in September or October. Children and the elderly are expected to be among those given priority in receiving doses.

Tests of the vaccine are being fast-tracked. However, health officials in the United States will remember a swine flu vaccine campaign in 1976, which was stopped after unexpectedly high numbers of patients suffered a paralysing condition called Guillain-Barre Syndrome.

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