Studies have shown that several commonly prescribed SSRIs – including Zoloft, Depakote, and Paxil – may be putting infants at risk for developing heart defects at the very beginning of their lives. The heart defects that have been tied to those drugs are as follows:

• Zoloft – transposition of the great arteries, tetralogy of fallot, hypoplastic left and right heart syndrome, atrial septal defect
• Paxil – atrial and ventricular septal defects (holes in the heart), tetralogy of fallot, double outlet right ventrical, transposition of the great arteries

Many of these conditions require surgery and put infants at risk for further health complications. Women should use caution when taking SSRIs or other medications during pregnancy to protect their children from heart defects and other health problems.

While SSRIs cause a number of side effects in people who take them, mothers who take SSRIs while pregnant may be putting their babies at risk for additional side effects, some very serious. These SSRI medications have been linked to the following birth defects:

• Zoloft – club foot, lung defects, asthma/breathing problems, craniosynostosis, omphalocele, limb reduction
• Paxil – persistent pulmonary hypertension of the newborn (PPHN), cardiomyopathy, craniosynostosis, spina bifida, club foot

As with any medication, women who take SSRIs should talk to their doctors if they are pregnant or plan to become pregnant while on the medication.

Missing chromosomes and other genes that don’t work properly can lead to malformations in a newborn baby’s body that cannot be prevented by an unborn baby’s environment. However, a mother’s activities during pregnancy do play a large role in determining the health of her baby at birth.

Certain illnesses in the mother during pregnancy, such as German measles and rubella, have been shown to increase the risk of certain birth defects. The use of substances such as alcohol, tobacco, and illicit drugs also has been shown to make newborns more susceptible to defects.

The use of some medications during pregnancy has been linked to an increased risk of certain birth defects. Research has linked ingestion of valproic acid, found in the anti-seizure drug Depakote, to spina bifida, cleft palate, and malformations of the heart, brain, and spinal cord.

Zoloft, an antidepressant, has been tied to a number of infant heart problems, including atrial and ventricular septal defects, transposition of the great arteries, and tetrology of fallot. Studies have also tied Zoloft use to persistent pulmonary hypertension of the newborn (PPHN), craniosynostosis, and club foot.

Women who are pregnant are advised to talk to their doctors about which drugs are safe to take and how to care for themselves to provide the best possible environment for their babies’ growth.

The drug “paroxetine” is manufactured, promoted, distributed, labeled and marketed by GlaxoSmithKline under the trade name Paxil, Paxil Oral Suspension, and Paxil CR. Paxil is a member of a class of drugs known as “selective serotonin reuptake inhibitors” or “SSRIs.”

Paxil was first approved for use in the United States by the FDA in 1992 for the treatment of depression in adults. The American Medical Association estimates that over 1 percent of pregnant women in the US, or more than 40,000, are taking antidepressants.

Recently, new concerns have been raised about the safety of antidepressants during pregnancy, mostly among the SSRI class of drugs. Some studies have found an increased risk of a potentially fatal breathing disorder and an increased risk of seizures and fetal death among infants born to mothers using a broad spectrum of SSRI’s.

Since September 2005 information has indicated that Paxil may cause birth defects including, heart, lung, abdominal wall, and cranial defects. According to the FDA, in a study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants.

Paxil crosses the placenta, which could have important implications for the developing fetus. Serotonin (the neurotransmitter that Paxil primarily affects) plays a roll in the fetal development of the heart.

Heart Birth Defects: The FDA issued a Public Health Advisory for Paxil on December 8, 2005 based on U.S. and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations.

Lung Birth Defects: On July 19, 2006 the FDA issued another Public Health Advisory for Paxil based on a study that suggests there may be additional risks of SSRI medications, including Paxil, during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.

Abdominal Birth Defects: GSK – GlaxoSmithKline, maker of Paxil, sent a letter to doctors and healthcare professionals in September, 2005 advising them of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI-antidepressant were more likely than those who were not exposed to have an infant with omphalocele (an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel. The strongest effect was reported to be with Paxil, paroxetine, which accounted for 36% of all SSRI exposures.

Cranial Birth Defects: GSK – GlaxoSmithKline included in the September, 2005 “Dear Doctor” letter that the authors of the above study also found an association of exposure to any SSRI-antidepressant and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)