A Japanese government-backed research group has found no evidence that Tamiflu causes abnormal behavior in young people, a health ministry official says. The study, which could lead to the lifting of warnings in Japan for children between the ages of 10 and 19, was conducted in response to incidents in which young people jumped from buildings while taking the flu med.
The findings will be presented to a drug safety panel at the ministry, which may decide to withdraw warnings against Tamiflu use in young people. "The timing of the presentation is not decided, but we want to do it as soon as possible," Tsutomu Matsuda, the health ministry official, said at a briefing. The warnings were issued in March.
The study, which was funded by the health ministry, analyzed 9,715 patients under the age of 18 who were diagnosed with the flu last winter. About 12 percent of 7,487 patients taking Tamiflu exhibited abnormal behavior, compared with 13 percent of the 2,228 who weren't taking the treatment. A spokesman for Roche's Chugai Pharmaceutical declined to comment on the results.
Last November, an FDA panel recommended that Tamiflu and Glaxo's Relenza, the two most common flu drugs, carry revised warnings about the risks of psychiatric side effects. And early last year, European regulators recommended a stronger warning for patients taking the Tamiflu treatment after reports of convulsions, abnormal behavior and hallucinations.
Source: wire reports