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FDA examining Oseltamivir risks by John Pluenneke

If you read FierceHealthcare, you had advance warning of this one on  Monday. The Wall Street Journal reported yesterday afternoon that the  Food and Drug Administration is probing as many as 12 deaths it  believes may be linked to oseltamivir (i.e. Tamiflu) in Japan.  According to the paper, all of the victims were children.

Quoting from the source:

The FDA said there were 32 reports of "neuropsychiatric" adverse events, 31 of which happened in Japan, and included abnormal behavior, hallucinations, convulsions and encephalitis. The agency said it received a report of two patients, ages 12 and 13, jumping out of their windows after receiving two doses of Tamiflu.

The antiviral, which is jointly distributed by Roche and Gilead Life Sciences, is considered the best available treatment for the H5N1 virus, although not everybody agrees it will work. Given the recent hype about the drug, this is a development worth watching closely. Apparently the FDA has known about these allegations for some time – as in for many months. Expect a lot of talk in the media about this story and its implications once it sinks in.

Also expect the story to take center stage in the fight in Washington over the liability protections vaccine makers and drug companies say they want …Update: On Friday, an FDA advisory panel said it could find no evidence linking Tamiflu with the deaths in Japan.  Meanwhile, in response to public pressure, Japan’s independent Pharmaceuticals and Medical Devices agency  said it will begin publishing detailed data on all reports of adverse events it recieves related to prescription drugs and medical devices starting in January 2006.

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