Heart Defects

Selective serotonin reuptake inhibitors (SSRIs) are a class of antidepressant drugs that have a strong association with the development of congenital heart defects in babies when taken by women during pregnancy. Medical research has also shown there is a greater risk that children exposed to SSRIs during the fetal stage will be born with brain development issues and spinal defects. It is estimated that nearly 20% of pregnant women suffer from depression and up to 13% of them use antidepressants at some stage of the pregnancy. Some of the most popular SSRI antidepressants such as Prozac, Paxil, and Zoloft have been the focus of thousands of lawsuits across the country as plaintiffs seek compensation for the SSRI birth defects their babies developed due to in-utero exposure to these medications.

Combining psychotherapy with prescriptions for antidepressant drugs has been viewed as an effective way to treat depression and certain anxiety disorders. The SSRI drugs approved by the FDA to treat depression include Celexa, Lexapro, Paxil, Zoloft, Prozac, and Symbyax. By changing the levels of serotonin in the brain, the SSRIs are able to help improve a person’s mood. However, clinical research has confirmed that certain SSRIs may have serious consequences to the fetus when taken during pregnancy.

Studies link SSRIs and heart defects in newborns

Several studies investigated whether SSRIs jeopardized the health of newborns when they were exposed to the drugs as a fetus. A study published in the American Journal of Medicine in 2007 evaluated the risk of birth defects in children when the mothers used SSRIs during the first trimester of their pregnancies. According to the study’s results, the risk of children having septal heart defects doubled when the mother used Zoloft (sertraline) during the early stages of the pregnancy. Unborn children exposed to Paxil were three times as likely to develop right ventricular outflow tract obstruction defects.

In 2009, the British Journal of Medicine published a study that examined close to half a million children in Denmark. The Danish researchers found that children born to mothers who used SSRI antidepressants during pregnancy were more likely to suffer from septal heart defects than children born to mothers who weren’t exposed to the drugs. When women used multiple antidepressants, there was a five-fold increase in children who developed heart defects.

Taking SSRIs while pregnant not only puts the unborn child at risk of having heart birth defects, but there may also be developmental issues and musculoskeletal abnormalities. A 2006 study in the New England Journal of Medicine stated that pregnant women who used SSRIs after the 20th week of pregnancy were six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN) compared to pregnant women who didn’t use SSRIs. According to FDA adverse event reports and medical studies, other SSRI birth defects include club foot, gastroschisis, cleft lip/palate, skull defects, and spinal cord defects.

Types of heart birth defects

A small number of congenital heart defects in newborns may resolve after the child receives proper medical treatment, but other defects may compromise the child’s long-term health and be life-threatening.

Some of the heart defects that have been attributed to SSRIs are:

• Atrial septal defect (ASD)
• Ventricular septal defect (VSD)
• Right ventricular outflow tract obstruction defect
• Coarctation of the aorta
• Hypoplastic left heart syndrome
• Tetralogy of fallot
• Transposition of the great arteries (TGA or TOGA)

Heart defect complications and treatment

Atrial and ventricular septal defects are two of the most common heart problems reported. Septal defects occur when there is a hole in the wall that separates the right and left side of the heart. The malformation makes it more difficult for the brain, soft tissues, and organs to get the oxygen-rich blood they need in order to function properly. The physician can detect the problem by using a stethoscope and taking a chest x-ray. Severe cases of the condition can lead to stroke, heart failure, or heart arrhythmia. Sometimes the septal defects heal on their own, while more serious cases usually require surgery.

Right ventricular outflow tract obstruction defect is a medical condition in which the right chamber of the heart becomes obstructed. The blockage makes it harder for the blood to pass into the primary arteries of the heart. Chest x-rays and a chest catherization can be used to diagnose the condition. Physicians may perform a surgical or non-surgical procedure to remove the obstruction.

Hypoplastic left heart syndrome occurs when the left side of the heart isn’t fully developed. As a result, it impedes the body’s ability to properly pump blood to the lungs and other parts of the body. Fluid buildup in the lungs, development of blood clots, and heart arrhythmias are some of the complications associated with the potentially fatal condition. A physician can perform surgery in order to restore the blood flow at a normal rate.

A coarctation of the aorta appears when the largest artery stemming from the heart is narrowed. Complications from the condition may lead to stroke, high blood pressure, and a brain aneurysm. It’s possible to detect the heart defect with a chest x-ray, MRI, or ECG test. Most cases require surgery or balloon angioplasty in order to widen the narrow artery.

Tetralogy of fallot is comprised of multiple heart defects that prevent the body from transporting enough oxygen in the blood.When babies don’t receive treatment for the condition, additional health problems such as bacterial infections and permanent disability may develop. Chest x-rays and blood tests are often administered to diagnose the condition. Physicians need to perform surgery in order to improve the flow of oxygen-rich blood throughout the body.

Symptoms of heart defects

Since certain heart defects can be potentially fatal, it is imperative to know which symptoms to look for so that the proper tests and medical treatment can be administered as needed.

Common signs that indicate a newborn may be suffering from heart problems are:

• Irregular heartbeats or heart palpitations
• Prolonged crying
• Delayed development
• Poor weight gain
• Fatigue
• Shortness of breath or difficulty breathing
• Loss of consciousness
• Pale or discolored skin

FDA warnings regarding SSRI birth defects

In light of the growing concern regarding the link between pre-natal exposure to SSRIs and heart defects in children, the FDA issued warnings to inform patients of these safety risks. On September 7, 2005, the FDA announced to patients and medical professionals that using Paxil during the first trimester of pregnancy increased the risk of newborns being born with heart defects. In 2006, the federal agency warned that SSRI antidepressants put newborns at risk of developing PPHN. The FDA also requested drug manufacturers update the health risks on their respective warning labels.

On April 1, 2011, the FDA ordered that Prozac warning labels be modified to reflect the risk of babies developing heart defects if women used the antidepressant during pregnancy. Eight months later, the agency announced that labels for SSRIs would also be updated to include the risk of newborns developing PPHN if they are exposed to the drugs in-utero. The need for healthcare professionals to provide effective treatment to pregnant women suffering from depression must be balanced with protecting the well-being of the fetus. Therefore, the FDA recommends that women thoroughly discuss the potential medical risks of using SSRIs with their physicians in order to make an informed decision about the most effective form of treatment.