- Lawyers are alleging that, according to a May 2014 internal report at Pfizer, women taking Zoloft (sertraline) had an increased risk of having babies with heart defects.
- There are currently more than 1,000 lawsuits against Pfizer related to failure to disclose this risk. Many of them are from women who took the drug in the mid-2000's.
- In 2005, Zoloft was the most popular antidepressant, with sales of $2.6 billion. It lost patent protection in 2006.
Pfizer's response to the allegations in this class-action lawsuit is that a review of the safety data did not "signal for congenital anomalies and that a comprehensive review of the literature did not support an association between use of Zoloft and birth defects, including cardiac anomalies."
Moreover, Pfizer contends that the information which plaintiffs for the lawyers are using has been taken out of context. While it is not clear how this case will turn out, a similar case against GSK, involving lack of full disclosure of Paxil (paroxetine)-related safety risks resulted in $3 billion in rewards in a class-action case.
In terms of the risks associated with Zoloft in women who are pregnant while taking the drug, the specific heart-defect risks include atrial septal defect, congenital heart disease and growth retardation, according to the report.