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FDA Frets about Flu Drugs' Side Effects

Suicidal, violent thoughts reported in some young adults





November 26, 2007    Spanish

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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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