FDA wants labels on flu drugs warning of child brain disorders

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. FDA’s panel of outside experts will consider the government’s proposed labeling at its meeting Tuesday. FDA is not required to follow the advice of its outside experts, though it usually does.

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.”

Over 48 million patients, including 21 million children, have taken Tamiflu since it was approved in 1999. The drug, which comes in capsule and liquid form, had sales of $2.4 billion last year.

There have been no child deaths connected with Relenza, but regulators said children taking the drug have shown similar neurological problems.

The label for British drug maker Glaxo’s Relenza does not list any neurological problems. Tamiflu’s current label lists the potential for self-injury and delirium, but does not mention that these behaviors could result in death. The FDA’s proposed label would include that information.