Paxil, Prozac Birth Defect Risk Seen in CDC Study of Antidepressants

Side effects of older antidepressants like Paxil and Prozac appear to increase the risk of children suffering rare birth defects, according to a government study. However, similar medications like Zoloft, Celexa and Lexapro do not appear to carry a birth defect risk. 

Data on nearly 28,000 women were reviewed by researchers from the U.S. Centers for Disease Control and Prevention (CDC) in a study published in the medical journal BMJ on July 8.

The study reviewed the birth defect risk with antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which include some of the most widely used prescription drugs in the United States. While the researchers identified a link between birth defects and Paxil or Prozac use during pregnancy, the study indicates that it does not appear to be a class-wide effect.

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Contrary to other studies that have suggested side effects of Zoloft increase the risk of birth defects, researchers found to find a link in this most recent study.

Researchers looked at data involving nearly 18,000 mothers who had children with birth defects, and nearly 10,000 mothers who had children without defects, born between 1997 and 2009. They compared the results to the use of the SSRI antidepressants Paxil, Prozac, Zoloft, Celexa, and Lexapro.

The data appears to show no connection between the risk of birth defects and the side effects of Zoloft, Celexa, or Lexapro. However, Paxil (paroxetine) was linked to an increased risk of anecephaly, atrial septal defects, right ventricular outflow tract obstruction defects, gastroschisis, and omphalocele. Prozac (fluoxetine) was linked to an increased risk of right ventricular outflow tract obstruction defects and craniosynostosis.

The study concluded that these two drugs increased the risk of these birth defects from two to 3.5 times higher when taken during early pregnancy.

In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.

In 2010, Paxil’s manufacturer, GlaxoSmithKline, paid more than $1 billion to settle about 800 Paxil birth defect lawsuits.

Zoloft Birth Defect Risks

The study showed no correlation between Zoloft side effects and birth defects, but that has run counter to a number of studies and the FDA’s own warnings.

Zoloft (sertraline) is one of the most widely prescribed medications in the United States, and has been used by tens of millions of individuals. However, several studies have suggested that use of Zoloft by pregnant women has been linked to a potential increased risk of serious and potentially life-threatening birth defects and malformation for children.

In November 2006, the FDA added warnings about a potential risk of persistent pulmonary hypertension in newborns (PPHN) from Zoloft and other newer antidepressants when taken after the 20th week of pregnancy. The side effects of Zoloft and other similar medications were linked to a six times greater risk of PPHN.

In June 2007, studies found an association between the use of antidepressants like Zoloft early in the pregnancy and a risk of abnormal skull development, gastrointestinal abnormality and brain defects.

Pfizer currently faces more than 1,000 Zoloft birth defect lawsuits in state and federal courts. The company has won two defense verdicts in Zoloft claims at the state level in recent months where juries determined that the company was not liable for the children born with birth defects in those cases.


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