Pfizer report proposed Zoloft birth defect warnings

A scientist connected with Pfizer Inc. warned the company about a potential link between its SSRI antidepressant drug Zoloft and birth defects, according to a report cited by Bloomberg. The document, released as part of an ongoing Philadelphia Zoloft lawsuit, further recommended changes to the drug’s safety warning, the news service reported.

There are more than 1,000 lawsuits against Pfizer alleging that the company sold Zoloft knowing that it could cause heart complications in newborns.

The Pfizer drug safety official involved in the report had recommended last year that Zoloft change its warning labels. This was going on while the company publicly stated Zoloft was not proven to cause congenital heart problems.

Francesca Kolitsopoulous, who was an associate director in Pfizer’s epidemiology group and safety unit, said in the internal company report that she reviewed published studies showing a connection between Pfizer’s medicine and cardiac malformations which could be causal.

Her report from April 2014 concluded that researches had found links between Zoloft and septal heart defects (holes in the heart). Kolitsopoulous proposed changing the drug’s warning label to add the findings of some of the researchers she had reviewed where potential links between the drug’s use and birth defects were
found.

Furthermore, an October 1998 report that was also made public in the Philadelphia case, found 25 cases involving congenital abnormalities or other “adverse events” were possibly related to Zoloft use.

A review of the side effect reports showed that at least 16 cases where there was no obvious cause for the birth defect other than the mother’s use of Zoloft, the documents showed.

The company, which made $3.3 billion in Zoloft sales in 2005, successfully defended its first trial last April in St. Louis. The jury sided with Pfizer and against the claim that Zoloft caused a boy to have three open-heart surgeries and a pacemaker implanted.

However, the St. Louis trial verdict was before this document came out as a result of the ongoing case in Philadelphia where plaintiff claims her cardiac defect, a hole in her heart, was because of her bipolar mother’s use of Zoloft. Her family is seeking at least $2.4 million in damages to cover her future medical expenses.

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