FDA Issues Updated Warning for Zoloft Birth Defects

A growing number of mothers have filed lawsuits, claiming that their their babies developed birth defects resulting from Zoloft use during pregnancy. Known as sertraline generically, Zoloft is prescribed to treat depression, panic attacks, post-traumatic stress disorder, and obsessive-compulsive disorder, among other conditions. It has enjoyed great popularity and success on the U.S. market, thanks in part due to its reportedly low incidence of Zoloft side effects.

Zoloft birth defects provoke Zoloft FDA warnings

In December 1991, the U.S. Food and Drug Administration (FDA) first approved Zoloft for sale in the United States. Five years later, in February 2006, the New England Journal of Medicine published a study that revealed that babies born to women taking SSRI antidepressants like Zoloft after their 20th week of pregnancy were six times more likely to give birth to children with persistent pulmonary hypertension of a newborn (PPHN).

In July 2006, the FDA issued a consumer alert warning the public that Zoloft could cause harm in pregnant women. The FDA elaborated, stating that women who took Zoloft during pregnancy were more likely to give birth to babies with Zoloft birth defects, especially Zoloft PPHN.

Zoloft FDA warnings updated

On December 14, 2011, the FDA issued an updated Zoloft safety announcement that indicated a more limited risk for newborns to develop Zoloft PPHN. The agency’s first warning had been based on information from just one study – that published in the New England Journal of Medicine – but subsequent studies on Zoloft birth defects had revealed somewhat inconsistent and, in some cases, contradictory findings.

While some studies showed that taking Zoloft during pregnancy increased the risk of a child developing neonatal Zoloft PPHN, other studies were unable to establish a conclusive link between Zoloft and the condition.

As a result of this dueling data, the FDA advised physicians to continue treating pregnant mothers as appropriate. However, the agency also asked the medical community to report any adverse effects, especially Zoloft birth defects, caused by taking Zoloft during pregnancy.

Lawsuits follow Zoloft FDA warnings

After the 2006 FDA announcement regarding Zoloft birth defects, some affected women contacted a Zoloft lawyer to discuss the legal ramifications of their children’s conditions, and to seek advice regarding the potential of filing a Zoloft lawsuit.

Though the FDA issued its updated warning in December 2011, women whose children had allegedly developed Zoloft birth defects continue to seek legal advice, and to file Zoloft lawsuits.

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