EU drugs panel says Tamiflu benefits outweigh risks
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LONDON/ZURICH (Reuters) - A panel of European experts said the benefits of Swiss drugmaker Roche's influenza drug Tamiflu outweighed the risks, but that it would closely monitor reports of safety concerns in Japan.
The European Medicines Agency said on Friday that "if any concerns emerge, further action will be taken."
But its Committee for Medicinal Products for Human Use "maintains its opinion that the benefits of Tamiflu outweigh its risks when the product is used according to the adopted recommendations."
Japanese health officials issued an alert over giving Tamiflu to teenagers on Wednesday after a series of cases, including teen suicides, fueled concerns the drug could induce psychiatric symptoms.
Roche said data from the United States and Japan showed there was no established causal link between Tamiflu, seen as effective against a possible pandemic triggered by bird flu, and neuropsychiatric symptoms.
"Everything is going to be monitored," said Roche spokeswoman Martina Rupp. "All events that are being reported are studied."
No definite link has been established between Tamiflu and the incidents in Japan, Rupp said, and the warnings do not affect Roche's sales forecast of between 800 million and 1.2 billion Swiss francs ($662 million-$993 million) in 2007.
"We don't understand the rationale for the actions that were taken," Rupp said.
