Personal Injury Law

Tamiflu Finally Gets Stronger Delirium Warning

By Jane Akre

As flu season winds down, the makers of Tamiflu have been forced to put stronger language on its label warning of the potential for psychiatric problems.

Swiss pharmaceutical company Roche has sent letters to doctors that hundreds of cases of delirium and some self-injury has been seen among people taking the prescription Tamiflu. 

Psychiatric problems have been seen among Japanese children, sometimes proving fatal, the FDA was told during a meeting last November, the third meeting on adverse events concerning Tamiflu.

At least five children died from "falling from windows or balconies or running into traffic". Japan discontinued recommending Tamiflu for children and teens ages 10 through 19.

Japan accounts for the bulk,  two-thirds of Tamiflu prescriptions amounting to $2.4 billion for Roche.

The new stronger Roche label says that "the contribution of Tamiflu to these events has not been established." and "patients with influenza should be closely monitored for signs of abnormal behavior"

About 48 million people have taken Tamiflu (oseltamivir phosphate) since it was approved. 

Flu can cause delirium among other physical ailments such as fever, body aches, nausea and diarrhea.

It was approved for use in children ages one through 12 in December 2005. It is not approved for use in infants.  #

Full post as published by InjuryBoard on March 04, 2008 (boomark / email).