FDA update Tamiflu (oseltamivir) label
admin November 14th, 2006
Patients who take Tamiflu should be closely monitored for signs of abnormal behavior, health officials said Monday in announcing an updated label for the flu drug.
The added precaution comes after reports of more than 100 new cases of delirium, hallucinations and other unusual psychiatric behavior in children treated with the drug. Most were Japanese children.
The Food and Drug Administration said a relationship between the drug and the behavior had not been established and that the updated label was “intended to mitigate a potential risk associated with Tamiflu.” It recommends that close monitoring begin immediately after starting treatment with the drug
From the Seattle PI: the whole article is worth reading.
We considered psychiatric reactions to oseltamivir in our March 2006 Bulletin. [PDF]
The FDA say:
Roche and FDA notified healthcare professionals of revisions to the PRECAUTIONS/Neuropsychiatric Events and Patient Information sections of the prescribing information for Tamiflu, indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and for the prophylaxis of influenza in patients 1 year and older.There have been postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. People with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior.
FDA documentation [all in PDF format]:
Roche Letter.
Prescribing Information.
Patient Information.
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