Paxil and Congenital Heart Defects
Paxil heart birth defect overview
The Food and Drug Administration (FDA) has concluded that exposure to paroxetine in the first three months of pregnancy may increase the risk for cardiac malformations -- including Atrial and Ventricular Septal Defects. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.
The Paxil side effect findings are based on two separate studies - conducted with the Swedish national registry and a United States insurance claims database - indicating that infants born to mothers who used paroxetine during the first trimester have, at a minimum, risk increase of 1.5 fold.
The FDA is awaiting the final results of these studies. Until the final results are provided, the FDA is recommending the following:
Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. If the decision is made to discontinue paroxetine and switch to another antidepressant or cease antidepressant therapy, paroxetine discontinuation should be undertaken only as directed in the prescribing information. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.
Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.
Atrial septal defect (ASD)
An atrial septal defect (ASD) is a hole in the wall between the upper chambers of your heart. The condition is present from birth, known as congenital. There are various degrees of ASD.
Smaller atrial septal defects may close on their own during infancy or early childhood development. Large atrial septal defects can damage ones heart and/or lungs. An adult who has had atrial septal defect (undetected) for decades may have a shortened life span. Surgery is usually necessary to repair atrial septal defects to prevent complications.
Mount Sinai explains:
Septal defects are a type of congenital heart problem in which there is a hole in the wall that separates the chambers of the heart. The word “septal" refers to the wall between the chambers, and “congenital” describes a condition that has been present since before birth. Congenital heart disease occurs in just 4-12 out of 1,000 births.
In a normal heart, the blood flows in from the body to the right atrium, goes into the right ventricle, and then goes to the lungs to pick up fresh oxygen. Then, the blood returns to the left atrium, goes into the left ventricle, and goes out to the rest of the body.
When there is a hole in the wall between the two atria or the two ventricles, blood can flow directly between them. In this case, the blood usually moves from left to right. This causes blood that has already been refreshed with oxygen to flow back into the right side of the heart and then into the lungs again. As a result, both the heart and lungs have to work harder than necessary because blood has to make one or more unnecessary passages through the lungs.
ventricular septal defect (VSD)
Ventricular septal defect (VSD), a congenital or present at birth defect, is an opening in the ventricular septum, or dividing wall between the two lower chambers of the heart known as the right and left ventricles
In a healthy heart, oxygen-poor blood returns to the right atrium from the body, travels to the right ventricle, then is pumped into the lungs where it receives oxygen. Oxygen-rich blood returns to the left atrium from the lungs, passes into the left ventricle, then is pumped out to the body through the aorta.
A ventricular septal defect allows oxygen-rich blood to pass from the left ventricle through the opening in the septum, and then mix with oxygen-poor blood in the right ventricle.
The American Heart Association details:
Problems You May Have
Most people whose uncomplicated ventricular septal defects are repaired early in life don't have any significant long-term problems. In some people, the heart muscle may be less able to contract. This requires diuretics, agents to help the heart pump better and drugs to control blood pressure. Also, if pulmonary hypertension develops (it's uncommon), you may need more medical therapy.
Will You Need More Surgery?
People whose ventricular septal defects are repaired rarely need more surgery unless residual defects are seen afterwards. If this occurs, whether you'll need surgery depends upon the size of the residual defects.
Other Paxil Birth Defects
Paxil Medical and Legal Assistance
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