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WASHINGTON, Fri. --- US regulators are studying the deaths of 12 children in Japan who took Roche AG’s flu-fighting drug Tamiflu, but it was difficult to tell whether the drug played a role in any of the cases, officials said yesterday. The US Food and Drug Administration said it was “concerned” that 32 psychiatric events, such as hallucinations and abnormal behavior, also had been reported in children who took Tamiflu. The drug 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 today. 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 website, Roche said: “There is no increase of deaths and neuropsychiatric events n patients on Tamiflu versus influenza patients in general”. |
Interest in Tamiflu has rises as experts around the world warn of the possibility of an H5N1 bird flu pandemic in people. This week Roche reported two possible suicides of Japanese youth who took Tamiflu but said there was no clear evidence. --- Reuters.
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