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...
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Case Title

Dolin v. Smithkline Beecham Corporation, et al


Case Number

1:12-cv-06403

Court

Illinois Northern

Nature of Suit

365(Personal Inj. Prod. Liability)

Judge

Honorable William T. Hart

Date Filed

August 13, 2012

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