Side effects of Tamiflu
Whilst it is possible that Tamiflu may help reduce the symptoms of swine flu, there have also be reports of potentially serious side effects of the drug
The most common side effects of Tamiflu are nausea and vomiting, although some incidences of self-injury and delirium with the use of Tamiflu in patients with the flu have been reported (mostly from Japan). These reports were primarily among children, although the exact relationship of these reported events to Tamiflu is not known.
The 2 most serious incidents in Japan took place in February 2004 and February 2005. 2 teenagers displayed abnormal behaviour before their deaths.
In the first case, a 17-year-old ran out of his house and jumped over a railing, falling into the path of a truck. In the second, a teenager fell to his death from the ninth floor of his apartment building.
By 2005 an estimated 33m people around the world have received Tamiflu. During the 2004-05 flu season in Japan, six million took the drug.
Since then, Japanese authorities have amended the patient information which comes with the drug to list psychiatric effects, such as delusions, in the list of side effects. However, a spokesman for the EMEA, said it had not been felt necessary to put similar warnings on the medication labelling in Europe.
A spokeswoman for Roche, the manufacturers of Tamiflu, said the company was aware of the two Japanese cases involving instances of "abnormal behaviour".
She added: "The information on these two cases has been shared with other regulatory authorities around the world, who have taken them into consideration and made the decision that no change to the summary of product characteristics was warranted.
"These conditions are known complications of influenza and its associated high fever.
"A number of studies have clearly shown that use of Tamiflu does not increase the likelihood of such events occurring in patients with influenza."
The EMEA had evaluated 48 reports of psychiatric side effects from Tamiflu as part of a regular safety review of the drug in July this year.
Most - 28 - of those reports had come from Japan, with 10 coming from the US, five from Canada, three from Germany and two from France.
They related to serious abnormal psychiatric behaviour, such as delirium and hallucinations.
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