FDA Wants Zoloft Labeling Changes Over Birth Defect Risk

The U.S. Food and Drug Administration wants Pfizer Inc. to modify safety warnings for its antidepressant Zoloft and acknowledge for the first time that some studies linked the mood-altering medication to heart defects in newborns. The body of evidence on the drug still finds no tie to birth defects.

The FDA asked Pfizer in August to alter Zoloft’s warnings to show some researchers have found an “increased risk of congenital cardiac defects” in babies whose mothers took the drug, according to court papers filed earlier this month.

The request was part of a widespread initiative by the FDA to reformat drug labels across the industry, Pfizer said in an e-mailed statement.

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