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Potential Link between Zoloft and Birth Defects Identified in Pfizer Report

Jun 10, 2015

A Pfizer report warning that Zoloft may be linked to birth defects may make it more difficult for the pharmaceutical company to dodge litigation, Bloomberg reports. The April 2014 document shows that Francesca Kolitsopoulous, who was an associate director in Pfizer's Worldwide Safety Strategy unit's epidemiology, reviewed studies and found that the antidepressant was linked to "cardiac malformations, which could be causal." There are over 1,000 lawsuits filed on behalf of individuals who allege that Zoloft is to blame for cardiac abnormalities in infants. Pfizer has continually denied these allegations.

According to Kolitsopoulous' review, researchers identified links between Zoloft and septal heart defects. This is a congenital condition that causes a hole in a baby’s heart. Studies also showed that the drug was correlated with a birth defect known as omphalocele, where organs or intestines form outside the abdomen. In light of this evidence, Kolitsopoulous suggested revising the drug's warning label to include information about possible birth defects. "While the risks may appear to be increased for specific birth defects, these defects are rare and the absolute risks small," she stated, according to Bloomberg.

Recently, a pediatric cardiologist gave expert testimony in the Philadelphia trial. Dr. Ra-id Abdulla of Rush University, testified that the antidepressant was the only likely cause of the defects and that the mother had no other risk factors. "My opinion is that Zoloft … has the ability to cause abnormal developments of the heart," Dr. Abdulla said, according to Law360. "Zoloft was the only agent that the mother was exposed to."

Bloomberg also reports that in 1998, Pfizer researchers identified over a dozen side-effect reports about birth defects where Zoloft was used during pregnancy; use of the drug could not be ruled out as a cause of these conditions. This report has been presented as evidence during the trial.

The lawsuit alleges that use of Zoloft caused congenital heart defects in a child whose mother took Zoloft during pregnancy. According to the lawsuit, she reported using the drug during her first obstetrician appointment but was not instructed to stop taking it.

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