The safety of Tamiflu, the anti-flu drug, has been questioned for the second time in a week following reports that it has been linked to the deaths of 12 children in Japan // .
The drug is being stockpiled by governments around the world preparing for a threatened flu pandemic, but American drug regulators are to review its status today.
European regulators said on Monday they were monitoring the psychological effects of the drug after it was linked to the suicides of two Japanese teenagers.
In a report posted online, the US Food and Drug Administration said on Friday that 12 children had died in Japan from causes including heart attack, suicide, pneumonia and acute pancreatitis. Four had suffered a sudden death, which was an unusual phenomenon in otherwise healthy children. All had taken Tamiflu.
Deaths from influenza are uncommon among both children with and without high-risk conditions, but do occur, the FDA report said. Attribution of causality for the reports of sudden death and cardio-pulmonary arrest are extremely difficult to interpret because there is limited information leading up to the event. It added that it was concerning that 32 psychiatric events, such as hallucinations and abnormal behaviour, had been reported in children who took Tamiflu.
A panel of the FDA is examining reports of adverse reactions to Tamiflu as part of a wider review of how medicines work in children. One question they will have to address is how to distinguish the effects of the drug from the effects of the flu.
In a separate summary posted on the FDA web site, Roche, the manufacturer of Tamiflu, said: There is no increase in deaths and neuropsychiatric events in patients on Tamiflu versus influenza patients in general. Officials from the FDA and the Swiss drugs giant will present information about the cases to an FDA advisory panel today.
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