Complain about a product or service

FDA Probes Tamiflu's Effect on Kids

November 18, 2005

Bird Flu • FDA Gains Insight to Bird Flu Virus • New Flu Bug Proves Resistant to Antiviral Drugs • Report: Nation Not Ready For Flu Pandemic • Antiviral Overuse Could Aid Deadly Flu • 1918 Flu Virus Offers Clues to Prevent Pandemics • Scientists Report Progress Toward Bird Flu 'Cure' • Bird Flu Not the Only Animal Disease Threat • Bird Flu Vaccine Trials 'Encouraging' • FDA Frets about Flu Drugs' Side Effects • World Not Ready For Bird Flu • Researchers: Bird Flu Pandemic Inevitable • Bird Flu Scare in Virginia • FDA Issues Flu Vaccine Guidelines • FDA Approves First Bird Flu Vaccine • More Flu Bugs Show Resistance To Anti-Virals • Seasonal Flu Shot Might Offer Some Bird Flu Protection • Experts Concerned about Tamiflu Overuse • Study Finds Much Bird Flu Planning is Misplaced • U.S. Orders More Bird Flu Vaccine • Scientists Identify Genetic Changes That Could Lead to Bird Flu Pandemic • Drug Interaction Can Render Tamiflu Ineffective • New Bird Flu Variant Renews Pandemic Concerns • Researchers Find New Weapon Against Flu Virus • Researchers Test Spreadability of Bird Flu Viruses to Humans • GlaxoSmithKline Claims Bird Flu Breaththrough • Global Corporations Struggle to Plan For Pandemic • Flu Pandemic Is "Inevitable," EU Experts Warn • Bird Flu Virus May Have Mutated In Indonesian Cases • Indonesian Nurse May Have Bird Flu • Study Warns of "Chaos" and "Panic" If Bird Flu Strikes • Investigators Find No Evidence Bird Flu Virus Has Mutated • Scientists Fear Bird Flu Virus May Have Mutated • Airlines Queasy About Quarantining Bird Flu Victims • More ...

Is Tamiflu safe for kids? With a potential bird flu pandemic in the making, the Food and Drug Administration (FDA) is looking for answers, in the wake of reports that 12 children died in Japan after being trested with Tamiflu, a powerful antiviral drug.

Tamiflu is currently approved for treatment of uncomplicated influenza A and B in patients 1 year of age or older and is the leading candidate for widespread use if a bird flu pandemic breaks out. While there are no vaccines against bird flu, health officials believe Tamiflu might be effective in helping victims recover from it.

The stepped-up safety review is mandated by the Best Pharmaceuticals For Children Act because of reports of adverse events in children 16 years of age or younger, including unusual neurologic or psychiatric events such as delirium, hallucinations, confusion, abnormal behavior, convulsions, and encephalitis.

These events were reported almost entirely in children from Japan who received Tamiflu according to Japanese treatment.

The review identified a total of 12 deaths in pediatric patients since Tamiflu's approval. All of the pediatric deaths were reported in Japanese children. In many of these cases, FDA said a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail in the reports.

“Initially, it was not clear why the neuropsychiatric adverse events and deaths were reported almost entirely in Japanese children. The FDA receives adverse event reports from all over the world and usually adverse events are roughly the same from different reporting countries," the agency said. "The reports of death and neuropsychiatric events associated with Tamiflu, almost entirely from Japan, was unusual enough to prompt further evaluation."

The FDA said it has requested additional information from both Hoffman-La Roche, the pharmaceutical company which produces Tamiflu, and the Japanese Ministry of Health, Labor, and Welfare. FDA said it is evaluating several possible explanations for the adverse events.

“The Pediatric Advisory Committee discussion is not directly addressing any issues related to pandemic flu preparations,” the FDA said in a statement. “Indirectly, a better understanding of Tamiflu safety in children will be useful should a pandemic occur and there is widespread use of Tamiflu.”

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Share		Follow us on Twitter.