Tamiflu effects on children probed

By | Wednesday, October 17, 2007

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Drug-safety experts will review the safety of a popular flu medication that has been associated with the deaths of several children in Japan.

The Food and Drug Administration's Pediatric Advisory Committee will meet Nov. 27 to discuss neurological and behavioral side effects in children who have taken Tamiflu, manufactured by Roche Holding AG.

The committee meets twice a year to examine the side effects of drugs recently approved for use by youngsters. Children's medication is facing increased scrutiny after last week's withdrawal of 14 over-the-counter cold medicines for infants.

The safety of Tamiflu came into question two years ago after Japanese regulators reported cases of hallucinations and suicides among children who were taking the drug.

No reports of similar side effects have surfaced in the U.S. since federal regulators approved the Tamiflu influenza treatment for children in July. However, the FDA advisory committee has been monitoring Tamiflu since the incidents in Japan occurred.

The safety of Tamiflu is significant because it is being stockpiled around the world as a defense against a bird flu pandemic. Tamiflu was the first drug to show real efficacy in helping people with avian flu and is the World Health Organization's recommended medicine in managing patients infected with the virus.

Despite reports of several deaths in Southeast Asia, there have been no reported cases of bird flu in humans in the U.S.

Roche, a Swiss drug company, revised Tamiflu's prescribing information last year to encourage doctors to monitor patients for signs of abnormal behavior.

Roche said the influenza virus rather than Tamiflu is the cause of the reported side effects.

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