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 Information

Case Title

Dolin v. Smithkline Beecham Corporation, et al

Case Number



Illinois Northern

Nature of Suit

365(Personal Inj. Prod. Liability)


Honorable William T. Hart

Date Filed

August 13, 2012

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Government Agencies

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