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FDA Asks Pfizer to Change Zoloft Warnings

The agency’s request is part of an initiative to reformat drug labels

The FDA wants Pfizer to modify safety warnings for its antidepressant sertraline (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.

As Bloomberg notes, the FDA asked Pfizer in August to alter sertraline’s warnings to show that 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 emailed statement.

“The new language, which is still in draft form, 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," Pfizer said.

Pfizer is fighting lawsuits by hundreds of women who say they weren’t adequately warned that the drug could cause defects in their newborns. While some legal experts say the label change could help the company fend off future lawsuits, it could also help bolster claims by those who have already sued over Zoloft, once the most prescribed antidepressant in the U.S.

“Since the FDA is basically forcing them to acknowledge the existence of credible studies showing Zoloft may cause heart defects, a jury could conclude they were ignoring or hiding those links to sell more of their product,” said Erik Gordon, a University of Michigan law professor, who teaches classes about how drugs are developed and regulated.

Regulators also noted in their suggestions that the vast majority of Zoloft’s research found “no difference in major birth defect risk” for users of the medication, according to the filings. Zoloft’s current label says there are “no adequate and well-controlled” studies of pregnant women.

Pfizer’s lawyers revealed the suggested changes in a federal court hearing on Sept. 1 in Philadelphia. The company maintains that the medication doesn’t cause heart defects and that it properly warned women and their doctors about the drug’s risks.

Earlier this year, Pfizer persuaded juries in St. Louis and Philadelphia that its current label explicitly urged doctors to examine the drug’s risks before prescribing it to pregnant women. Both state court panels ruled for the company in the only two Zoloft cases that have gone to trial. The first federal trial is scheduled for January.

Source: Bloomberg; September 17, 2015.

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