Fw: FDA recommends precaution for this season's flu drugs.

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FDA Recommends Precautionary Warnings for This Season's Flu Drugs

Nov 29, 2007

PharmExec Direct

An FDA review team, recommended last week that precautionary warnings be added to two influenza vaccines, Roche's Tamiflu and GlaxoKline's Relenza, noting possible neuropsychiatric side effects in children.

"While there have not been noticeable changes in the types or pattern of neuropsychiatric adverse events reported in association with the use of Tamiflu, the number of cases continued to increase," the advisory team stated in a report.

"Regardless of whether they represent a drug-class adverse event, a drug–disease interaction, or a disease manifestation, healthcare providers should be aware of neuropsychiatric events and parents should be instructed to monitor their children closely when beginning medication for influenza."

Both Roche and GlaxoKline stated that they would work with FDA to identify the problem, and clinical and nonclinical trials are being conducted.

The report notes that there have been 25 deaths reported in patients under 21 receiving Tamiflu. Only three were in the United States. Side effects have been reported more heavily in Japan, a country that is far more proactive in giving influenza vaccines. No deaths have been reported involving Relenza.

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Source: PharmExec DirectDate: 11/29/2007

An FDA review team advised that flu vaccines manufactured by GSK and Roche include precautionary warnings citing the potential for neuropsychiatric side effects. Adverse events have been reported in Japan, and now the United States is starting to pay attention.