FDA Mulls Tougher Warning Label on Kids' ... ( Troubled behaviors and sudden deaths ...)

FDA Mulls Tougher Warning Label on Kids' Flu Drugs

Date:11/27/2007

Troubled behaviors and sudden deaths have agency looking into Tamiflu; Relenza also under scrutiny.

TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and Drug Administration panel is meeting Tuesday to debate stronger warning labeling for the prescription flu drug Tamiflu (oseltamivir), linked recently to anecdotal reports of bizarre behaviors and deaths among children.

The FDA's Pediatric Advisory Committee will begin considering label changes to Tamiflu and another flu drug, Relenza (zanamivir), when used in children.

A safety review released Friday by the FDA's Division of Antiviral Products does urge stronger label warnings for the medications, including stricter monitoring of children taking these drugs.

One expert is concerned that the public may overreact, however.

"I am not a fan of replacing fear of a disease with fear of the treatment for the disease," said Dr. Marc Siegel, a clinical associate professor of medicine at New York University School of Medicine in New York City. "You don't need to go from one panic to another," he added.

Tamiflu is overused, however, Siegel said. "It's supposed to be used in a very narrow window, and I am not surprised that there have been psychiatric side effects related to this drug," he said. "Maybe the new warning will lead to less overuse," he said.

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 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 adults committed suicide. So far, there haven't be
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