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Page: << Prev | 1 | 2 | 3 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.
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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.
GlaxoSmithKline, the maker of Relenza, also released a statement after the meeting. "GSK was pleased to have the opportunity to present safety information on Relenza to the Pediatric Advisory Committee showing no conclusive evidence of a causal association between Relenza and neuropsychiatric events," the statement said.
"We believe the current Relenza U.S. prescribing information accurately reflects the safety profile of the drug," the company added.
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.
Tamiflu is approved both as a preventative and a treatment for flu for adults and children aged 1 year and older.
Relenza is approved as both a flu preventative and a treatment in adults and children aged 5 years old and older.
More information
For more on the flu, visit the U.S. Centers for Disease Control and Prevention.
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