The FDA determined that exposure to Paxil in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations.
At the FDA’s request, the manufacturer GlaxoSmithKline changed Paxil’s pregnancy category from C to D and added new data and recommendations to the “Warnings” section of the prescribing information.
Also Wellbutrin, a popular antidepressant, has been linked to heart-related birth defects for women who took the drug one month prior to getting pregnant and during the first trimester of pregnancy.
Most of the cardiac defects observed in studies were atrial septal defects (ASD) or ventricular septal defects (VSD), conditions in which the wall between the right and left sides of the heart is not completely developed.
— Atrial septal defect or ASD is a form of congenital heart defect that enables blood flow between the left and right atria via the interatrial septum.
Many atrial septal defects close without treatment during childhood. For ASDs that don't close, some small defects don't cause any problems and may not require any intervention. But, many ASDs eventually require surgery to be corrected.
— Pulmonary valve stenosis or PS is a fixed obstruction of flow from the right ventricle of the heart to the pulmonary artery and is usually initially diagnosed in childhood. If the pulmonary stenosis is severe, especially in babies, some blueness may occur. Older children usually have no symptoms.
The pulmonary valve can be treated to improve the obstruction and leak, but the valve can't be made normal. Treatment is needed when the pressure in the right ventricle is high (even if there are no symptoms). In most children the obstruction can be relieved during cardiac catheterization by balloon valvuloplasty. In this procedure, a special tool, a catheter containing a balloon, is placed across the pulmonary valve. The balloon is inflated for a short time to stretch open the valve. Some children may need surgery.
— Ventricular septal defect or VSD is usually symptom-free at birth, manifesting a few weeks after birth. Congenital VSDs are frequently associated with other congenital conditions, such as Down syndrome.
Children and adults who have a ventricular septal defect that is large or is causing significant symptoms usually need surgery to close the defect. If your baby has a VSD that needs surgical repair, the procedure will likely be scheduled in your baby's first year of life.
Every mother and family dreams of a safe pregnancy and healthy baby. If your baby suffers from congenital heart defects which you think or your doctor has diagnosed because of antidepressants taken during while pregnant – please contact Anapol Schwartz, a personal injury law firm with an emphasis on unsafe drugs. Let us help you to determine what your legal options are.