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New Data from the US and Japan Support: No Established Causal Link,Between Neuropsychiatric Symptoms and Treatment with Tamiflu US,Databases Indicate Psychiatric Symptoms Lower in Influenza Patients,Taking Tamiflu Versus Those Not Taking Tamiflu

BASEL, Switzerland, March 20, 2007 -- Clinical studies have shown (1) similar rates of neurologic and psychiatric events in pediatric influenza patients being treated with Tamiflu compared to those receiving no treatment for their influenza. Furthermore, recent data derived from US health insurance records (2) between 1999-2006 of over 101,000 influenza patients treated with Tamiflu and over 225,000 influenza patients not taking Tamiflu have shown that the Tamiflu treated patients showed a lower likelihood of experiencing a central nervous system (CNS) event such as delirium, delusion, confusion, hallucination, aggressive behaviour etc compared to those not receiving treatment (p<0.001). During the 2005/2006 influenza season the Japanese Ministry of Health Labor and Welfare coordinated a scientific study on the occurrence of influenza-associated symptoms. In accordance with previous clinical trials data the study reported no increase in neuropsychiatric events in patients with influenza receiving Tamiflu versus those not receiving the drug (3).

Influenza is a serious, sometimes life-threatening disease and the infecting virus gives rise to a number of unpleasant symptoms including a high fever (40 degrees or more), tender joints/limbs, severe malaise, a racking cough and in some cases delirium, confusion and general disorientation. Influenza associated delirium and neuropsychiatric disorders are not uncommon and occur in the United States in approximately 4 of every 100 000 influenza patients in the US, resulting in hospitalization (4). The incidence in Japan is believed even higher. A recent survey based on 1219 Japanese pediatric patients reported abnormal behavior in 1.7% of the patients (5). A second study reported 50 Japanese pediatric patients hospitalized for influenza. The most common reason for hospitalization was "abnormal behavior" (28%) (6).

Eduard Holdener, Roche's Chief Medical Offic
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