SSSSSSSSSSSShHHHHHHHHHHHHHH
FDA probes deaths of Tamiflu patients
Thu Nov 17, 2005 1:15 PM ET
U.N. warns against panic in China
China confirms human bird flu
By Lisa Richwine
WASHINGTON (Reuters) - U.S. regulators are studying the deaths of 12 children in Japan who took Roche AG's flu-fighting drug Tamiflu, officials said on Thursday, but they said it was difficult to tell whether the drug played a role in any of the cases.
The U.S. Food and Drug Administration said it was "concerning" that 32 psychiatric events, such as hallucinations and abnormal behavior, also had been reported in children who took Tamiflu, which is in high demand because it is considered to be one of the best defenses against avian flu in people.
All but one of the psychiatric problems also were reported in Japan, the FDA said.
The agency will ask for input on the cases from an advisory panel of outside experts at a public meeting on Friday. Officials said the review was part of the routine monitoring of the safety of medicines used by children.
In a separate summary posted on the FDA Web site, Roche said: "There is no increase in deaths and neuropsychiatric events in patients on Tamiflu versus influenza patients in general."