Global Research, November 28, 2007
Associated Press - 2007-11-24
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.