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FDA Frets about Flu Drugs' Side Effects

Suicidal, violent thoughts reported in some young adults

November 26, 2007    Spanish

Bird Flu • 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 ...

The Food and Drug Administration Pediatric Advisory Committee meets this week and topic A on the agenda is possible dangerous psychiatric side effects of influenza drugs Tamiflu and Relenza. Both drugs are seen as a first line of defense in the event of a bird flu pandemic.

Documents posted on the FDA Web site express concerns about recent studies, which showed nearly 600 cases in which patients who took Tamiflu experienced "neuropsychiatric events" such as delirium, delusions or hallucinations.

The episodes sometimes led to impulsive behavior and self-injury, according to the documents.

According to the studies, the majority of the patients suffering adverse effects were age 21 or younger. There were at least three reports of suicides among adults in the studies.

The documents describe cases in which patients experienced delirium, resulting in impulsive behavior that led to self-injury. In some cases subjects in the study tried to escape from windows or jump from balconies.

“In addition, there were a few patients who became aggressive or violent and/or performed acts that were injurious to themselves,” the documents said.

Tamiflu, produced by Roche Holdings, is available in both pill and syrup form. Besides its role in combating an early flu pandemic, it is most commonly used to treat seasonal influenza.

Relenza, an antiviral drug made by GlaxoSmithKline, also has potential side effects, according to the FDA documents. Studies highlight 115 cases of psychiatric problems, including 74 cases in patients younger than 21. No potentially related fatalities were reported.

The FDA documents said the agency should consider strengthen the warning labels on both drugs.

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