- A newly-emerged document shows that last year, a scientist warned Pfizer management about the link between Zoloft (sertraline) and birth defects. He recommended that Pfizer update its safety label to reflect this risk, Bloomberg reports.
- The news comes as Pfizer is facing more than 1,000 lawsuits alleging the firm sold Zoloft despite knowing medication could cause cardiac abnormalities in newborns.
- Pfizer asserts that the reports mischaracterize Zoloft's risks and that the basis for the idea that Zoloft is linked with congenital birth defects is based on "cherry-picked" information. Recent regulatory filings in both the U.S. and the E.U. support Pfzier's position that there isn't a credible link between Zoloft and birth defects.
In 2005, Zoloft was the most popular antidepressant, with sales of roughly $3.3 billion. It lost patent protection in 2006. Many of the lawsuits harken back to that period 10 years ago when pregnant women were routinely prescribed Zoloft.
Like most stories, this one has two sides. On one side is Pfizer, which has many supporters in this case, including a state-court jury, which concluded in April that Logyn Pesante's birth defects were not related to Zoloft.
On the other side are experts like Francesca Olitsopolous, who was associate director of Pfizer's Worldwide Safety Strategy unit's Epidemiology group. Her extensive review led her to the understanding that scientists had found links between Zoloft and septal heart defects, as well as omphalocele, a birth defect of the abdominal wall in which the intestines and organs form outside the belly. However, she said that the risks are very small.
A current case in Philadelphia involves a woman named Mia Robinson, who is seeking damages claiming that her mother took Zoloft, which led to her cardiac defects. She is seeking $2.4 million in damages. Pfizer is attempting to use available evidence to support its position.
The Zoloft case is Robinson v. Wolters Kluwer Health Inc., July Term, 2011, No. 778, Control No. 14123047, Pennsylvania Court of Common Pleas of Philadelphia County (Philadelphia).