FDA Requests Warning Label Change For Antidepressant

Bloomberg News (9/18, Koons) reports that the Food and Drug Administration requested Pfizer Inc. in August to “alter Zoloft’s [sertraline] 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.

Legal experts believe that the label change could help “bolster claims by those who have already sued over Zoloft,” but could also “help the company fend off future lawsuits.” According to a statement by Pfizer, the new label language, although still being drafted, “reflects the extensive science supporting the safety and efficacy of Zoloft, stating a complete review of the scientific evidence finds that there is no difference in birth defect risks between pregnant women who took Zoloft and those who did not.”

Related Links:

— “Pfizer Weighing FDA Request to Change Zoloft’s Warnings,” Cynthia Koons and Jef Feeley, Bloomberg News, September 17, 2015.

Posted in In The News.