New Safety Information Regarding Paroxetine:
Findings Suggest Increased Risk Over Other Antidepressants,
Of Congenital Malformations, Following First Trimester Exposure To Paroxetine

GlaxoSmithKline Inc. (GSK)
September 29, 2005

GlaxoSmithKline Inc. (GSK), following discussions with Health Canada, would like to inform you of important new safety information regarding the use of paroxetine during the first trimester of pregnancy.

Background
GSK initiated a retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy from January 1995 to June 2003. The study was conducted in 3,581 pregnant women. A preliminary analysis has recently been conducted which has shown a 2.2 fold increase [adjusted odds ratios of 2.20 (95% CI: 1.34-3.63)] for congenital malformations as a whole, and a 2.08 fold increase [2.08 OR (95% CI: 1.03-4.23)] for cardiovascular malformations alone, for paroxetine as compared to the other antidepressants in the database.

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