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FDA Asks Pfizer to Change Zoloft Label

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The U.S. Food and Drug Administration (FDA) has asked Pfizer to change Zoloft’s label to reflect the warnings of researchers who have found increased risk of congenital cardiac defects in infants whose mothers took the medication.

According to Pfizer, the request is part of a larger initiative to reformat drug labels across the industry, but it will undoubtedly give new focus to claims of Zoloft’s association with congenital birth defects. Although the majority of Zoloft studies have found no difference in major birth defect risk for pregnant women, the drug’s current label states that there are “no adequate and well-controlled studies of pregnant women.”

What is Zoloft?

Zoloft is the brand name of sertraline, an antidepressant prescribed to treat major depressive disorders. It is in a class of antidepressants known as selective serotonin inhibitors, or SSRIs, that work by controlling the levels of serotonin in the brain. SSRIs are the most prescribed type of antidepressants in the U.S. today. The FDA approved Zoloft in 1999 and by 2005 it was the most popular antidepressant in the nation, grossing nearly $2.6 billion.

Zoloft Lawsuits

Pfizer has defended numerous lawsuits alleging that the company did not adequately warn pregnant women about the drug’s potential risks. Although Pfizer successfully defended the first two Zoloft cases to go to trial in April and June 2015, the company still faces hundreds of lawsuits with similar allegations.

A Pfizer Inc. report recently disclosed during a Zoloft trial in Philadelphia allegedly shows that the company’s own scientists alerted top executives about a possible link between Zoloft and birth defects in 2014, according to Bloomberg Business. Pfizer researchers have also acknowledged a 1998 report stating that they’d found more than a dozen side-effect reports about birth defects in infants for which Zoloft use in their mothers could not be ruled out.