FDA Pushes Pfizer to update Zoloft Warning Labels 

Facing pressure from the FDA, drug giant Pfizer has been asked to revise the label on its antidepressant Zoloft to include warnings that the drug may cause fetal heart defects. The request was made of Pfizer after the selective serotonin reuptake inhibitor (“SSRI”) was linked to causing an increased risk of congenital cardiac defects in children born to mothers who took Zoloft during their pregnancies. Several studies support this link, including one published in the British Medical Journal  in 2009 and another published in January 2015 in the American Journal of Obstetrics & Gynecology, supporting the hundreds of lawsuits that have been filed against Pfizer alleging that patients were not adequately warned that Zoloft could cause defects in newborns.

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