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FDA Panel Backs Tougher Warning for Tamiflu
Date:11/27/2007

Advisers say current labeling doesn't reflect reports of bizarre behaviors and sudden deaths

TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Tuesday that the prescription flu drug Tamiflu (oseltamivir) should have a stronger warning label to reflect reports of bizarre behaviors and deaths among children who use the medication.

The FDA's Pediatric Advisory Committee, in a 9-5 vote, said that drug maker Roche Holding AG should change its prescribing information because it doesn't adequately explain side effects reported by hundreds of patients in Japan and the United States, according to Bloomberg News.

The drug's label mentions reports of delirium and self-injury, primarily among children in Japan, but the advisory panel said the language should state that several patients died as a result of these behaviors, the Associated Press reported.

In addition, the panel recommended that labeling for the flu drug Relenza, (zanamivir), should also reflect reports of abnormal behavior, according to Bloomberg.

The FDA is not obliged to follow its expert panels' recommendation, but it usually does. A safety review released Friday by the FDA's Division of Antiviral Products urged stronger label warnings for both drugs, including stricter monitoring of children taking these drugs.

According to the FDA safety review, there have been 596 reported cases of psychiatric behavior associated with Tamiflu use. Most of these cases happened among patients aged 21 or younger. The majority (75 percent) occurred in Japan.

Fifty-nine of the cases were classified as delirium with impulsive behavior and self-injury. Delirium, delusions, hallucinations or psychosis accounted for another 225 cases. In total, five children died "as a result of falls from windows or balconies or running into traffic," the safety review found, and three adul
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