FDA panel to review Tamiflu's effect on brain

By Anita Manning, USA TODAY
A Food and Drug Administration panel on Tuesday will review reports of abnormal behavior and other brain effects in more than 1,800 children who had taken the flu medicine Tamiflu since its approval in 1999, including 55 in the USA.

Twenty-two of the U.S. reports were considered "serious," with symptoms such as convulsions, delirium or delusions, says Terry Hurley, spokesman for drugmaker Roche Laboratories.

None of the U.S. cases resulted in death. But in Japan, Hurley says, five deaths have been reported in children under 16 as a result of neurological or psychiatric problems. "Four were fatal falls, and one was encephalitis in a patient with leukemia," he says.

In a statement, the company says demand dropped after reports in February that "several teenage patients with influenza who were also taking Tamiflu had fallen from buildings after taking the drug."

Hurley said in an e-mail that 1,745 of the 1,808 reports of problems associated with Tamiflu are in Japan. He said 81% of all reports were "defined as non-serious."

In the USA, Hurley said, 2.85 million Tamiflu prescriptions have been written since 1999. A year ago Roche added a warning to its package insert label saying "people with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu," and their behavior should be monitored.

The anti-viral medication, stockpiled in the millions by countries around the world for use in a flu pandemic, is licensed to treat or prevent flu in patients older than 1 year.

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It never gave me the urge to jump off of a building... it just helped me get over the flu quickly!

Moonbeam said:

Maybe it's worse for kids.