FDA Wants Added Label Warnings About Bizarre Behavior in Kids That Get 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. 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.
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. A company spokesman said Friday no signficant behavioral issues have been recorded in clinical studies or patient safety reports. Sales of the drug last year were roughly $187 million.
While FDA said the reports of dangerous side effects could result from an unusual strain of flu or a rare genetic reaction to the drugs, the agency wants language about the possible side effects added to labeling for physicians who prescribe Tamiflu and Relenza.
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.
In a statement Friday, Roche suggested it would consider changing the label.
"If the FDA concludes that it is valuable to place additional details on the label with regard to specific adverse event reports, then Roche is open to that consideration," the statement from Roche, which is headquartered in Basel, Switzerland, said.
However, the company also stressed there is no concrete evidence connecting its drug to the reported problems. It also pointed out that many children with flu experience neurological problems, even when they aren't taking medication.