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Drugmaker to put stronger warning label on flu drug

Infection Control Monitor, November 30, 2007

A Swiss drug manufacturer has agreed to put a stronger warning label on its flu drug Tamiflu, reported the Associated Press (AP).

 

The company, Roche Holding AG, accepted a recommendation made Tuesday by a U.S. Food and Drug Administration (FDA) panel that the label should say that several patients have died as result of abnormal behaviors.

 

A company spokesman said there is no connection between Tamiflu and reported cases of delirium and hallucinations. However, she said, all patients with full-blown flu should be warned that the illness itself poses a risk of psychiatric problems, not just for those taking Tamiflu, the AP reported. The FDA said nearly 600 cases of psychiatric problems have been reported in Tamiflu patients, with 75 percent of them coming from Japan, where five children have died after falling from windows or balconies or running into traffic. Several governments have stockpiled Tamiflu in case avian flu mutates to spark a human flu pandemic.

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