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FDA wants kid warnings on flu drugs

It recommends precautions about possible psychiatric side effects from Tamiflu and Relenza.

By Washington Post
Published November 24, 2007

WASHINGTON - Food and Drug Administration experts are recommending new label warnings about possible dangerous psychiatric side effects of influenza drugs Tamiflu and Relenza, according to FDA documents.

The documents, posted Friday on the agency's Web site, were prepared for a meeting Tuesday of the FDA's Pediatric Advisory Committee. Studies revealed 596 cases in which patients who took Tamiflu, made by Roche Holdings, experienced "neuropsychiatric events" such as delirium, delusions or hallucinations.

The problems tended to occur within 24 hours of first taking the drug, and the majority were in patients younger than 21, mostly in Japan, according to the documents. In five cases involving pediatric patients, the reported delirium resulted in death.

Tamiflu safety concerns arose two years ago after reports of deaths and psychiatric problems in children in Japan. U.S. labeling for Tamiflu notes that self-injury and delirium have occurred primarily among pediatric patients.

Now FDA regulators are recommending that U.S. labeling be updated to note that "fatalities have occurred in adult and pediatric patients in Japan, the onset may be abrupt, and fatal events have occurred." Regulators cautioned that no causal link has been established between the drug and the behavior.

The FDA said studies turned up 115 cases of psychiatric problems involving Relenza, made by GlaxoSmithKline.

[Last modified November 24, 2007, 00:59:45]