The FDA safety review also reported that in cases involving Relenza, mostly in Japan, there have been 115 reports of "delirium with impulsive behavior and self-injury in which the patient expressed 'fear' and attempted to flee or expressed a desire to 'jump,'" the agency said. There were no deaths associated with Relenza.
During its meeting on Tuesday, the advisory panel said it was unclear whether the psychiatric problems are a side effect of Tamiflu or the flu itself, AP reported.
At the hearing, representatives of Roche told the panelists that the flu itself, not Tamiflu, caused the bizarre behaviors.
"We feel that the current U.S. prescribing information is an accurate assessment of the current data," Jonathan Solsky, Roche's director of drug safety risk management, testified, according to Bloomberg.
In a statement released after the meeting, Roche reiterated its faith in the drug. "According to data analyzed from two U.S. claims databases of more than 150,000 patients, there is no increased risk for neuropsychiatric events in influenza patients treated with Tamiflu compared to untreated influenza patients," the statement said.
The FDA first began reviewing Tamiflu in 2005. Since November 2006, the drug's label has had a warning focused on self-injury and delirium, advising that patients be monitored during treatment. In March, the Japanese Ministry of Health, Labor and Welfare limited Tamiflu use in patients aged 10 to 19 years old.
One expert believes a new warning is appropriate for Tamiflu. "The idea that there have been 596 neuropsychiatric events is a reason for the FDA to put a strong warning on the label," said Dr. Marc Siegel, a clinical associate professor of medicine at New York University School of Medicine in New York City.
But he is a
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