Tamiflu needs stronger label warning: FDA experts

Tamiflu needs stronger label warning: FDA experts
A close up of Roche AG's Tamiflu pills, known generically as oseltamivir, are seen at the Center for Disease Control in Bangkok October 21, 2005. The safety of influenza drugs is under scrutiny as advisers to the U.S. Food and Drug Administration on Tuesday analyzed abnormal psychiatric behavior seen in some patients, especially children. Medical experts are reviewing cases of patients taking Roche Holding AG's (Adrees Latif/Reuters)GAITHERSBURG, Maryland (Reuters) - Advisers to the U.S.Food and Drug Administration said on Tuesday the labeling forRoche Holding AG's Tamiflu is not strong enough, amid reportsof abnormal psychiatric behavior and the deaths of somepatients.
The advisory panel also voted to change the label foranother flu drug, GlaxoSmithKline Plc's Relenza, to generallydenote cases of newly reported, but rare, neuropsychiatricevents.
Medical experts are reviewing cases of patients takingTamiflu and Relenza experiencing hallucinations, delirium andother abnormal behavior. In the case of Tamiflu, some erraticbehavior, including jumping from buildings, resulted in death.
The meeting marks the third public review of flu drugsafety, originally prompted by reports two years ago of a dozendeaths, including suicide, of children in Japan who had beentaking Tamiflu.
"The public expects to be made aware. I never hear on thepublic side that they are getting too much information," saidDr. Michael Fant, a pediatric expert at the University ofTexas, Houston, medical school, and panel member.
"If we're still wrestling with it, to me even though wedon't have anything definitive, that in and of itself warrantsconveying those concerns to the public."
The experts voted the current labeling on both drugs doesnot address the safety issues.
The FDA typically takes the advice of its expert panels.
(Reporting by Kim Dixon; editing by Andre Grenon)