Basel, 16 November 2006

Statement - Label changes for Tamiflu

Tamiflu (oseltamivir phosphate) was demonstrated in clinical trials to be a safe and effective medication for influenza prevention and treatment. Tamiflu was approved in 1999 and has been used by more than 42 million people in over 80 countries.  

Roche continuously reviews post-marketing safety information and provides regular updates to the regulatory agencies. Based upon reports received over the last influenza season Roche has agreed that the Tamiflu label in the US will be revised to include reports of neuropsychiatric events such as self-injury and delirium in patients with influenza. Reports of neuropsychiatric events in patients taking oseltamivir are very rare based on usage, and a causal relationship between the use of oseltamivir and the likelihood of neuropsychiatric events in influenza patients cannot be established.

In 2005, 103 psychological reports during treatment of influenza with Tamiflu were received, including 5 deaths. These events are extremely rare in relation to the number of patients treated during the influenza season. Based upon the information presented by the FDA we calculate that:  

• approximately 1 in 100'000 patients experienced psychological disorders
  
• approximately 1 out of 2 million patients treated died

None of these events could be established to have been caused by Tamiflu.  

Phase III pivotal trials conducted by Roche found similar reports of neurologic and psychiatric events in pediatric influenza patients being treated with Tamiflu and those receiving no treatment. In addition, a recent review of a US claims database showed no differences in the incidence of neuropsychiatric events between flu patients treated with Tamiflu and those who were not treated.

Influenza itself is a severe disease. High fever, which is a typical symptom of influenza, has been associated with neuropsychaitric disorders including hallucination or delirium.

The well-being of patients and the safe and effective use of our medications is a priority for Roche.  Roche continues to monitor the safety of Tamiflu through established reporting mechanisms and notify regulatory authorities of adverse events in line with regulatory requirements.