Feds want warning labels on children's flu drugs
WASHINGTON (AP) -- Federal health regulators are recommending new label warnings about neurological problems on a pair of children's flu drugs.
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.
25 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.