Is Tamiflu safe for children?

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From Heidi Green.

I WAS very alarmed to read that Tamiflu is being handed out to school children in Jersey.

Health and Social Services are either unaware of the recent studies regarding the efficacy of Tamiflu or have failed to read the warnings that even Roche (manufacturers of Tamiflu) have given.

A few facts every member of the public should know about Tamiflu:

• Tamiflu has not been tested on people under the age of 18 so therefore there are no human trials to deem it safe or effective for this age group.

• Japan was the first country to use Tamiflu to counter avian flu. Japanese health authorities have reported eight deaths directly related to Tamiflu, where all the victims were between the ages of 17 and two.

• Roche makes no secret of its limitations and states that ‘it can reduce the duration of symptoms by one day provided it is taken within 48 hours of symptoms appearing’. Wouldn’t sensible bed rest and an analgesic do the same without the potential risks associated with Tamiflu?

• Virologists were shocked to discover that even swine flu (H1N1) had spontaneously developed a near total resistance to Tamiflu during the most recent flu season (New Sci, 29 April 29, 2009: www.newscientist.com/article/dn8509-new-tamifluresistant-bird-flu-cases-stir-fears.html).

This latest health panic coincides almost exactly with when vast consignments of Tamiflu (bought to fight against avian flu) are coming to the end of their shelf life.

Without this recent health scare billions of dollars of Tamiflu will have to be discarded. (The US and UK have over $3 billion worth of Tamiflu) and our health guardians would have to explain themselves to their governments as to why they spent their taxpayers’ hard-earned cash on such a useless drug.

Health have sent out thousands of leaflets to households giving us basic sensible advice. No advice has been given on ways we can protect ourselves against the flu; such as advice on healthy lifestyle, nutrition and supplements.

For healthy individuals, bed rest, lots of fluids and warmth is the best medicine. There are a variety of drug free solutions for colds and flu.

These can be viewed on: www.wddtyhealthshop.com (click on special reports).

Statistics from previous pandemics show that a healthy immune system and good public sanitation are key in determining the virulence of a flu virus.

We need to take personal responsibility for ourselves and our families’ health and get ourselves properly informed and not just accept the blithe assurances by the industry, who stand to make billions from these types of health scares, that their drugs are safe and effective.

The Meadows,

Ivystill Lane,

St Saviour.

Dr Susan Turnbull, Deputy Medical Officer of Health, commented as follows:

Firstly, Tamiflu (generic name oseltamivir) has not, and will not be ‘handed out’ to school children in Jersey. Children (and adults) for who Tamiflu is recommended – either as treatment because they are unwell with swine flu, or as a precaution because they have been a contact of a known or strongly suspected case – have been advised to contact their GP, who after an assessment that the necessary criteria are met, will have provided a course of Tamiflu at the right dose for that individual.

Tamiflu was first approved in October 1999 by the US Food and Drug Administration for the treatment of influenza infection in adults. When Tamiflu’s safety profile for use in children was considered and the drug approved in 2005 by the US FDA, Tamiflu had been used by about 33 million patients worldwide.

Turning to the Japan issue, 24.5 million patients had used Tamiflu, 11.6 million of whom were children. It is true that 12 deaths in children aged one to 16 years had occurred. This number of reported deaths, placed into the context of overall usage, would be a rate of 1 death per million of the patients treated with Tamiflu. This is lower than published rates of mortality in children infected with influenza (2 per million paediatric patients).

Safety reporting is based on clinical trials and routine use from about 33 million patients worldwide; of these, about 13 million were children. Safety of Tamiflu is intensively monitored by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Tamiflu is approved as a treatment for the most common strains of influenza (types A and B), and works by attacking the influenza virus and its ability to multiply, rather than simply addressing influenza symptoms. It both reduces the severity of the illness, and reduces the transmission of the virus onwards to other people.

Tamiflu is also approved for the prevention of influenza. This medication is generally well tolerated: the most common side effects are nausea and vomiting, described as mild to moderate, usually in the first two days of treatment. Taking Tamiflu with food reduces the chance of having these side effects. Tamiflu is available for the treatment of influenza in more than 40 countries worldwide.

In Jersey, as I write at the end of June and still with a low number of confirmed cases of the new pandemic swine flu, we remain well placed in our efforts to reduce the rate of further spread of the virus to the minimum possible, while awaiting our first supplies of the new pandemic-specific vaccine in the autumn.

The next few weeks are particularly crucial in this aim; that is the period before the schools break up for the summer holidays. This is because schools often act as a ‘melting pot’ for acceleration of the spread of flu viruses. Why? Because children with flu are more infectious than adults, may not recognise as quickly that they are unwell, spend lengthy periods in close proximity to many others in the school environment, and may be less rigorous about hand and respiratory hygiene than adults.

Our current containment efforts would have little chance of success without sufficient Tamiflu for treatment of the ill, and as a precautionary measure for contacts to reduce the rate of transmission in our community. We should all be grateful to Jersey’s Strategic Pandemic Flu Committee, led by my colleague Dr Rosemary Geller, and to the States for their foresight in agreeing the funding. If these supplies had not been secured by Jersey on a contingency basis, we may well have been experiencing considerable difficulty in accessing the treatment we need for Islanders now.

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