Pfizer Internal Report Warns of Possible Link between Zoloft and Birth Defects

An internal report from Pfizer Inc. shows a scientist warned company executives last year about a potential link between the anti-depressant drug Zoloft and birth defects and recommended changes to the medication’s warning label.

The report could complicate the company’s efforts to fend off lawsuits from parents of children with malformed hearts. Pfizer has consistently rejected claims that Zoloft (sertraline) caused the abnormalities and on Monday the company said the document was taken out of context, Bloomberg Business reports. The child’s family is seeking at least $2.4 million to cover her future medical expenses.Pfizer faces more than a thousand lawsuits alleging the company sold Zoloft knowing it could cause cardiac abnormalities in newborns. The company successfully defended itself in the first lawsuit to go to trial in April, before the disclosure of the document last week in a case in Philadelphia, Bloomberg Business reports. Los Angeles attorney Jim Morris said, “I don’t see how they could go before a jury with a straight face and make that argument now that these documents have surfaced.” (Morris has tried product-liability cases against Pfizer, though none involving Zoloft.)

In the 1998 report introduced into evidence in the Philadelphia trial, Pfizer researchers acknowledged more than a dozen birth defect reports for which Zoloft use could not be ruled out as a cause. Pfizer said the internal review had been mischaracterized by the plaintiff’s lawyers. Company spokeswoman Christine Rogen Lindenboom said plaintiffs’ attorneys had “cherry-picked” data from the review of adverse event reports and ignored conclusions that contradicted their testimony. Lindenboom said recent filings with U.S. and European health regulators support Pfizer’s contention that no credible link has been found between Zoloft and birth defects.

Pfizer wants to persuade the Philadelphia jury to reject the claim that the child’s birth defects, including a hole in her heart, were caused by her bipolar mother’s use of Zoloft, according to Bloomberg Business. In April, the jury in a state court in St. Louis, rejected arguments that Zoloft caused heart defects that required a boy to have three open-heart surgeries and to have a pacemaker implanted.

Francesca Kolitsopoulos, associate director in Pfizer’s Worldwide Safety Strategy unit’s epidemiology group, said she reviewed published studies that showed an association between Zoloft and cardiac malformations, “which could be causal.” The April 2014 review concluded that researchers had found links between Zoloft use and septal heart defects, a congenital disorder that features a hole in a baby’s heart. The researchers also found ties between the Zoloft and omphalocele, a birth defect in which the intestines or organs form outside the belly. The report shows that Kolitsopoulous proposed modifying the Zoloft warning label to indicate that researchers had identified potential links to birth defects, according to Bloomberg Business.

The 1998 report, made public for the first time last week in the Philadelphia trial, shows that Pfizer safety monitors reviewed 50 side-effect reports from pregnant women who had taken Zoloft. Twenty-five cases involved “congenital abnormalities” or other adverse events “possibly related” to Zoloft use. In 16 of the cases, “there was no obvious cause” for the defect other than the mother’s use of the anti-depressant, the review showed, according to Bloomberg Business.

 

 

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