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Mar. 26, 2007
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The anti-flu drug that has been stockpiled by the Department of Health for a future epidemic has been given a new pack warning after reports of teenagers falling to their deaths from tower blocks.
Japan uses more than 60 per cent of the world's supply of Tamiflu
It has been reported that two 14-year-olds in Japan died in separate incidents while taking the antiviral drug Tamiflu.
The European Medicines Agency (EMEA) says packets of the drug will include new advice to patients and doctors about "neuro-psychiatric" events.
The packets will say: "Convulsion, depressed levels of consciousness, abnormal behaviour, hallucinations and delirium have been reported during Tamiflu administration, leading in rare cases to accidental injury.
"Patients, especially children and adolescents, should be closely monitored and their health care professional should be contacted immediately if the patient shows any sign of unusual behaviour."
Earlier this week the Japanese health authorities issued guidance to doctors advising them not to prescribe Tamiflu to those aged 10 to 20.
The Japanese government - which had said in the past that there were no direct links - said yesterday that it would open an inquiry to examine any links between the drug and abnormal behaviour.
The EMEA said in a statement that the Japanese cases had been detected through routine safety monitoring. "The agency's committee for medicinal products for human use [CHMP] has monitored closely all adverse drug reactions reported in connection with the use of Tamiflu since it was introduced in the EU in 2003.
"The EMEA and CHMP will continue to monitor closely any emerging safety information on Tamiflu including neuro-psychiatric disorders. If any concerns emerge, further action will be taken."
The committee said it considered that the benefits of Tamiflu outweighed its risks.
Japan uses more than 60 per cent of the world's supply of the drug, which is a front-line treatment in the event of an epidemic of human bird flu.
The Department of Health has stockpiled 14 million doses of the drug - enough to treat a quarter of the population in an epidemic.
A spokesman from Roche said: "Following a recent review of the antiviral drug Tamiflu (oseltamivir), the EMEA and CHMP have proposed wording in the precautions section of the European label to include an observed increase of neuro-psychiatric reports, mainly in Japan, in those patients being treated for influenza.
"As clinical studies have already shown, patients not treated with Tamiflu experience delirium and other events as a natural course of the infection and its associated high fever. The changes in labelling are a precautionary measure."
She said reports of neuro-psychiatric events in patients taking Tamiflu were rare and there was no established causal relationship between the drug and the likelihood of neuro-psychiatric events in influenza patients.