Product News and Recalls

Pfizer Reviewing FDA Request for Zoloft Label Change

fda requests pfizer update safety labels for zoloftPharmaceutical company Pfizer Inc. is reviewing a suggestion from the U.S. Food and Drug Administration (FDA) to modify safety warnings on labels of the popular antidepressant Zoloft. According to Bloomberg, court papers filed earlier this month reveal that the FDA asked Pfizer in August to update Zoloft’s warnings to reflect findings by some researchers that the drug may increase the risk of congenital heart defects in babies whose mothers took Zoloft during pregnancy.

Until Pfizer’s patent expired in 2006, Zoloft was the highest-grossing antidepressant on the market. The drug belongs to a class of medicines called selective serotonin reuptake inhibitors (SSRIs). Zoloft and other SSRIs have been linked in some studies to increased risk of birth defects in the babies of mothers who used the SSRI during pregnancy. Over 250 Zoloft birth defect lawsuits have been consolidated in a multidistrict litigation in the U.S. District Court for the Eastern District of Pennsylvania. Women who have filed Zoloft lawsuits claim that Pfizer failed to adequately warn them of the increased risk of birth defects posed by the drug. Recent evidence suggests that some of Pfizer’s own scientists knew of the increased risk of birth defects Zoloft may cause.

Up to now, Zoloft has been classified under pregnancy category C by the FDA. This means adverse effects on the fetus have been recognized in animal studies but not in human testing. But with the FDA overhauling its drug safety labeling system for pregnant women, the agency has requested that Pfizer reformat its label to indicate that some scientific studies have linked Zoloft to an increased chance of birth defects in children whose mothers took the drug while pregnant. While the new label does not confirm a link between Zoloft and birth defects, it nonetheless raises a flag that Pfizer may not want to have raised. As Bloomberg notes, while the updated label may safeguard against future lawsuits, it may also assist Zoloft plaintiffs who filed lawsuits before the reformatting.

Consult your doctor about any health concerns you may have. If you or a loved one gave birth to a child with a congenital defect after taking Zoloft during pregnancy, contact the birth defect lawyers at Lopez McHugh today for a free consultation. We can help determine whether you may qualify for legal damages in a Zoloft birth defect lawsuit.