Celexa Warnings and Alerts

Celexa, Lexapro and other selective serotonin reuptake inhibitor (SSRI) antidepressants continue to be prescribed to pregnant women despite possible serious risks to unborn babies. Scientific research has prompted the U.S. Food and Drug Administration (FDA) to issue a warning regarding SSRIs like Celexa due to the possible risk of birth defects in infants whose mothers took antidepressants during their pregnancy.

Category C

The FDA uses a pregnancy category system that classifies risk to a fetus when medication is taken during pregnancy. The FDA initially declared SSRI antidepressants, including Celexa, a pregnancy “category C” drug. Pregnancy “category C” simply means that a medicine has not been studied in pregnant women, but side effects to the fetus were found in animal studies. The pregnancy categories measure the teratogenic effects a drug has on a fetus. Teratogenic means that a drug or other substance is capable of interfering with the development of a fetus.

Congenital heart defects

In December 2005, the FDA issued Public Health Advisory declaring that, when taken during the first trimester of pregnancy, certain SSRI's similar to Celexa may increase the risk for certain congenital heart defects. The alert was prompted by studies showing the rise in risk of septal heart defects such as atrial or ventricular septal defects when mothers took certain SSRIs during their pregnancy. Both atrial and ventricular septal heart defects are conditions in which the wall between the right and left sides of the heart is not completely developed. These septal defects occasionally require open heart surgery.

PPHN

In July 2006, the FDA issued a Public Health Advisory detailing the results of a study published in the New England Journal of Medicine (NEJM). The study looked at the link between the use of SSRI antidepressants (including Celexa and Lexapro) during pregnancy and a life threatening disorder called Persistent Pulmonary Hypertension of the Newborn (PPHN). PPHN is a potentially deadly disorder in which an infant’s arteries to the lungs remain constricted after delivery, limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream. The study indicated that children born to mothers who took SSRI antidepressants early in pregnancy were six times more likely to have PPHN than babies born to mothers who did not take antidepressants during pregnancy

PPHN is a life threatening congenital disorder in which an infant’s arteries to the lungs remain constricted after delivery, limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream.

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