Date:
11/23/2007 11:52 AM FDA wants warnings about possible bizarre behavior
in kids that gete 2 widely used flu drugs
WASHINGTON (AP) _ Government health regulators
recommended adding label precautions about neurological problems
seen in children who have taken flu drugs made by Roche and
GlaxoSmithKline.
The Food and Drug Administration on Friday
released its safety review of Roche's Tamiflu and Glaxo's
Relenza. Next week, an outside group of pediatric experts
is scheduled to review the safety of several such drugs when
used in children.
FDA began reviewing Tamiflu's safety in 2005
after receiving reports of children experiencing neurological
problems, including hallucinations and convulsions.
Twenty-five patients under age 21 have died
while taking the drug, most of them in Japan. Five deaths
resulted from children "falling from windows or balconies
or running into traffic."
There have been no child deaths connected
with Relenza, but regulators said children taking the drug
have shown similar neurological problems.
While FDA said it isn't clear whether the
problems are directly related to the drugs, it recommends
adding language about the possible side effects to labeling
for physicians who prescribe Tamiflu and Relenza.
Besides being a drug side effect, the agency
said the behaviors alternately could result from an unusual
strain of flu or a rare genetic reaction to the drug.
Company representatives were not immediately
available for comment.
