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Roche Announces Shipments of New Supplies of Children's Tamiflu in the U.S.
Date:12/7/2009

acy of Tamiflu has not been established in immunocompromised patients.

Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

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.

In postmarketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu.
The most common adverse events reported in >1% of patients treated with Tamiflu and more commonly than in patients treated with placebo are:
- Treatment of adult and pediatric patients: nausea, vomiting
- Prophylaxis of adult and pediatric patients: nausea, vomiting, abdominal pain
Vaccination is considered the first line of defense against influenza.
Tamiflu is available for the treatment of influenza in more than 80 countries worldwide. Prescribing information for Tamif
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