FDA Rejected Paxil Label Changes, GSK Says In Suicide Trial

Law360, Chicago (March 15, 2017, 9:42 PM EDT) -- GlaxoSmithKline told an Illinois federal jury Wednesday that the U.S. Food and Drug Administration four times rejected a label change that would have alerted doctors of the increased risk of suicide in some adult patients taking Paxil, a warning that the widow of a Reed Smith partner says would have saved her husband's life.

GSK says it updated the label for Paxil in 2006 to highlight the results of a study that found a subgroup of adult patients with major depressive disorder could experience increased episodes of suicidal thoughts and behavior while on the drug.

But the FDA nixed the language...

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