SSRIs and PPHN in Newborns
Selective Serotonin Reuptake Inhibitors (SSRIs) are a form of antidepressants. In July of 2007, the New England Journal of Medicine published a study by the CDC (Centers for Disease Control and Prevention) that showed that babies born to mothers who took SSRIs such as Paxil®, Prozac®, and Zoloft® during the second half of pregnancy had a significantly increased risk of being born with Persistent Pulmonary Hypertension (PPHN). PPHN is a very serious respiratory disorder that is a failure of the normal circulatory transition that occurs after birth and which limits the newborn’s ability to provide itself with an adequate supply of oxygen-rich blood.
Data from this study indicate that the use of SSRIs during the second half of pregnancy may increase the risk of PPHN by as much as six times the normal risk. Historically, PPHN occurs in one to two infants per 1000 live births. However, data from this study suggest that when SSRIs are used during the second half of pregnancy, the rate of PPHN increases to five to six cases per 1000 live births.
Other birth defects tied to SSRIs by the CDC included anencphaly (birth without a forebrain), omphalocele (born with organs on the outside of the body), craniosynostosis (the premature closing of the bones of the infant’s skull), and delayed development of bones. Newborns also suffered from withdrawal symptoms, including irritability, high-pitched or weak crying, tremors, poor muscle tone, disturbed sleep, and respiratory distress.
Paxil® and the Risk of Infant Heart Defects
The U.S. Food and Drug Administration (FDA), on December 8, 2005, issued a Public Health Advisory in which it announced the results of two studies that examined the effects of Paxil® (paroxetine) use by pregnant women during the first trimester (first three months) of pregnancy. One study, which gathered data from the Swedish national registry, concluded that women who took Paxil® during the first three months of pregnancy doubled the risk that their babies would be both with a heart (cardiac) defect. In the second study, researchers examined a U.S. insurance claims database and concluded that babies whose mothers took Paxil® during the first trimester of pregnancy had a 50% greater risk of developing a cardiac malformation than babies whose mothers did not take Paxil® during the same time period.
The most common heart defects identified in the studies were atrial and ventricular septal defects, which are conditions in which the wall between the right and left sides of the heart is not completely developed. A ventricular septal defect (VSD) is a defect in the wall dividing the left and right ventricles of the heart. An atrial septal defect (ASD) involves the inter-atrial septum of the heart. These types of defects can range in severity from small defects that may resolve without treatment, to larger defects that require repair surgery.
Smoking During Pregnancy While On Antidepressants Increases Risk of Birth Defects
In December of 2008, an international study established a link between use of Prozac and Paxil by pregnant women and heart defects in children. According to the study, conducted in Israel, Italy, and Germany, women who take these medications in early pregnancy have an increased risk of giving birth to children with cardiovascular anomalies, neurodevelopmental defects, or functional problems. The study also found that smoking during pregnancy significantly increases the risk of giving birth to a child with a major cardiac malformation, and pregnant women using antidepressants are much more likely to smoke.