Pfizer, FDA Updating Pregnancy Caution On Zoloft Label

By Sindhu Sundar (September 18, 2015, 9:35 PM EDT) -- Pfizer Inc. is in talks with the U.S. Food and Drug Administration to update the label on its antidepressant Zoloft to acknowledge studies showing increased heart defect risks in children whose mothers took the drug early in their pregnancies, but the drugmaker stressed Friday that the proposal was not prompted by new data or litigation.

Pfizer says the proposed label change on Zoloft was prompted by an FDA move to revamp pregnancy labeling on all prescription drugs. (Credit: AP) The drugmaker, which is fielding multidistrict litigation in Pennsylvania federal court over cardiac birth defect risks, said the proposed label change was...

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