Law360, New York (November 28, 2007, 12:00 AM ET) -- A U.S. Food and Drug Administration advisory committee has recommended stronger warning labels for flu drugs sold by Roche Holding AG and GlaxoSmithKline Plc after reports showed an increase in psychotic reactions to the drugs in young patients, particularly in Japan.
On Tuesday, a majority of the FDA’s Pediatric Advisory Committee found that the current labeling for Roche’s flu drug Tamiflu does not “adequately address” safety concerns raised by reports of neuropsychiatric events experienced by patients.
The PAC recommended adding warnings to the label stating that...
FDA Advisers Recommend More Flu Drug Warnings
To view the full article, take a free trial now.
