ROCHE: STUDIES SHOW NO LINK BETWEEN TAMIFLU, PSYCHIATRIC SYMPTOMS

Study data from Japan and the U.S. show there is no established link between neuropsychiatric symptoms and Tamiflu, Roche has announced.

The U.S. FDA received 349 adverse event reports, including 12 reported deaths, connected to Tamiflu (oseltamivir phosphate) between March 2004 and April 2005. The majority of the events, including all of the deaths, occurred in Japan. All of the deaths involved children who died suddenly, several of them in their sleep, according to briefing documents from the FDA.

The Japanese Ministry of Health, Labor and Welfare conducted a study during the 2005/2006 flu season the on the occurrence of influenza-associated symptoms. In accordance with previously recorded data, the study showed no increase in neuropsychiatric events in influenza patients receiving Tamiflu compared with those not receiving the drug, Roche said.

In addition, data from seven years of U.S. health insurance records showed that the rate of incidents of psychiatric symptoms such as delirium or hallucinations was lower in patients who took Tamiflu than those who did not take it, the company added, according to the company.

Ovarall, no causal link between neuropsychiatric events and Tamiflu has been established, Roche said. More than 45 million influenza patients worldwide have taken Tamiflu.