Pfizer Weighing FDA Request to Change Zoloft's Warnings
- FDA suggests altering warnings on congenital cardiac defects
- Pfizer faces hundreds of lawsuits over the antidepressant
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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.