From: Reuters
Published November 27, 2007 05:39 PM

Tamiflu needs stronger label warning: FDA experts

GAITHERSBURG, Maryland (Reuters) - Advisers to the U.S. Food and Drug Administration said on Tuesday the labeling for Roche Holding AG's Tamiflu is not strong enough, amid reports of abnormal psychiatric behavior and the deaths of some patients.

The advisory panel also voted to change the label for another flu drug, GlaxoSmithKline Plc's Relenza, to generally denote cases of newly reported, but rare, neuropsychiatric events.

Medical experts are reviewing cases of patients taking Tamiflu and Relenza experiencing hallucinations, delirium and other abnormal behavior. In the case of Tamiflu, some erratic behavior, including jumping from buildings, resulted in death.

The meeting marks the third public review of flu drug safety, originally prompted by reports two years ago of a dozen deaths, including suicide, of children in Japan who had been taking Tamiflu.


"The public expects to be made aware. I never hear on the public side that they are getting too much information," said Dr. Michael Fant, a pediatric expert at the University of Texas, Houston, medical school, and panel member.

"If we're still wrestling with it, to me even though we don't have anything definitive, that in and of itself warrants conveying those concerns to the public."

The experts voted the current labeling on both drugs does not address the safety issues.

The FDA typically takes the advice of its expert panels.

(Reporting by Kim Dixon; editing by Andre Grenon)

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