A Food and Drug Administration advisory panel said Friday that it saw no evidence Roche AG's Tamiflu caused the deaths of 12 children in Japan, but it urged regulators to continue monitoring the flu medicine's use.
"The committee does not think, based on the data presented, that there's any evidence Tamiflu played a role in the deaths," said the panel's chairman, Robert Nelson.
Tamiflu is in high demand as countries stockpile the drug to fight a feared pandemic of avian flu.
The panel did recommend to the FDA that new information be added to the Tamiflu label about serious skin reactions, which already are listed as a possible side effect.
The committee, a group of independent experts, agreed that the agency should continue monitoring the safety of Tamiflu in children.
The FDA has been studying reports of 12 deaths and 32 cases of psychiatric problems in children who took the drug. All of the psychiatric events, which included hallucinations and abnormal behavior, also were reported in Japan.
Linda Lewis, an FDA medical officer, told the committee there was "insufficient evidence to establish that deaths and neuropsychiatric events represent a safety signal associated with Tamiflu."
The FDA has no current plan to add warnings about the deaths or psychiatric problems to the Tamiflu label, Lewis said.
Tamiflu is used widely in Japan to treat influenza. From 2001 to 2005, there were 24.5 million prescriptions in Japan and 6.5 million in the United States.