F.D.A. Staff Recommends a Warning on Flu Drugs
By BLOOMBERG NEWS
Published: November 24, 2007
The report, by staff members of the Food and Drug Administration, was posted yesterday in advance of an advisory panel meeting scheduled for Tuesday to review use of the antiviral medications Tamiflu, made by Roche Holding, and Relenza, from GlaxoSmithKline.
Five Japanese children who took Tamiflu and became delirious died, and there were reports of abnormal behavior among some children using Relenza, mainly in
There have been no fatalities in the
Regulators are not sure if the deaths and abnormal behavior were caused by the drugs, the flu virus or a combination of both, the F.D.A. staff members said in a memorandum written Nov. 9. They did not propose any new limits on use of the drugs. While governments worldwide have been stockpiling the drugs in case of an influenza epidemic, sales have slipped in recent months amid concerns about the safety of Tamiflu.
Tamiflu generated $257 million for Roche in the third quarter. Sales were down 62 percent from a year earlier. Relenza generated $58 million for Glaxo in the third quarter, down 7 percent.
Roche, based in
Officials for Glaxo did not immediately respond to a request for comment.
Tamiflu’s prescribing information was updated last year to tell doctors they should monitor patients for signs of abnormal behavior. The label should be revised again, the F.D.A. staff members said in the Nov. 9 memorandum, to alert doctors and family members that psychotic side effects may happen quickly and can be fatal.