Roche has informed HealthCare Professionals on recent update to the Tamiflu ( Oseltamivir ) package insert. The revisions to the product label are the result of recommendations made by the FDA Pediatric Advisory Committee meeting held on November 27, 2007.

The revised Precautions section of the Tamiflu capsules and oral suspension package insert now includes the following information and guidance under the Neuropsychiatric Events subheading:

Neuropsychiatric events

Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.

There have been postmarketing reports ( mostly from Japan ) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made but they appear to be uncommon based on Tamiflu usage data.
These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to these events has not been established.

Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

Source: FDA, 2008

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