Feds Will Decide If Tamiflu Makes Kids Bonkers, Suicidal

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Feds Will Decide If Tamiflu Makes Kids Bonkers, Suicidal

(October 12, 2007) - A U.S. advisory panel will review the safety of Roche Holding AG's influenza treatment Tamiflu in kids, two years after the drug was linked to the deaths of at least a dozen Japanese children.

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 the drug, according to a notice posted today on the agency's Web site. The panel has requested annual updates on Tamiflu safety since suicides, hallucinations and self-injury were reported in 2005.

The committee meets a few times a year to examine the side effects of drugs recently approved for use in children and older medicines linked to potential risks in the FDA's Adverse Event Reporting System. Drugs may pose risks in children that aren't seen in adult studies, as suggested by yesterday's withdrawal of 14 over-the-counter cold medicines for infants.

Roche revised Tamiflu's prescribing information last year to encourage doctors to monitor patients for signs of abnormal behavior. The Basel, Switzerland-based drugmaker says studies show that the flu, not the medicine, causes the reported side effects. Governments are also stockpiling Tamiflu for use in the event of a lethal worldwide outbreak of the flu.

On Nov. 28, the panel will review reports linked to GlaxoSmithKline Plc's asthma medication Serevent, Cephalon Inc.'s sleep-disorder drug Provigil, Gilead Sciences Inc.'s Emtriva, an HIV medicine, Novartis AG's cancer treatment Gleevec and Alcon Inc.'s eye drugs Azopt and Betaxon.

By: Catherine Larkin
Source: Bloomberg.com

Last updated: 10/07

Feds Will Decide If Tamiflu Makes Kids Bonkers, Suicidal

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