'Abnormal behavior' warning added to Tamiflu

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'Abnormal behavior' warning added to Tamiflu

 

http://blogs.usatoday.com/ondeadline/healthscience/index.html

A new warning about possible " abnormal behavior " has been added to

the label of Tamiflu after U.S. health officials received reports

from Japan about 103 cases of " delirium, hallucinations and other

unusual psychiatric behavior, " mostly in children, the Associated

Press says. The revision conforms with the Japanese label.

Previously the FDA-approved label cautioned about possible " seizure

and confusion. "

 

The Food and Drug Administration said today that scientists had not

yet established a relationship between the prescription drug and the

abnormal behavior, and that the new label was " intended to mitigate

a potential risk associated with Tamiflu. " Children being treated

with Tamiflu should be monitored closely as soon as it is

administered.

 

The Swiss pharmaceutical company that makes Tamiflu, Roche Holding

AG, said there was no evidence the drug caused the reported

behavior. Roche and the FDA both noted that " severe cases of the flu

can spark the abnormal behavior flagged in the updated label, " the

AP says.

 

The FDA approved Tamiflu for children in November 2005 after a panel

found no link between the drug and 12 deaths and 32 cases of

psychiatric disturbance in Japan.

 

Posted by Michael Winter on November 13, 2006 in Health/Science |

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