Federal health regulators are recommending new
label warnings about neurological problems on a pair of children's
The Food and Drug Administration has released its safety review
of Roche's Tamiflu and GlaxoSmithKline's Relenza. The FDA opened a
safety probe of Tamiflu in 2005 after receiving reports of children
experiencing hallucinations and convulsions.
Twenty-five patients under the age of 21 have died while taking
the drug, most of them in Japan. Five died from "falling from
windows or balconies or running into traffic."
No deaths have been connected with Relenza, but regulators say
children taking the drug have shown similar neurological problems.
An outside group of pediatric experts is scheduled to open its
own safety review next week.