Heart Defects - Consumer Justice Foundation

Heart Defects

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Effexor and Heart Defects

Effexor falls into the category of SNRI antidepressant medications, or serotonin-norepinephrine reuptake inhibitors. These drugs function by inhibiting the “reuptake” of both serotonin and norepinephrine, two neurotransmitters in the brain responsible for controlling mood. Similar to these drugs are SSRIs, or selective serotonin reuptake inhibitors, which act upon serotonin alone to relieve depression and improve certain mood disorders. Effexor (venlafaxine) was approved by the FDA in 1993 and has since been indicated for the treatment of major depressive disorder, social anxiety disorder and generalized anxiety disorder. The drug is also often used for off-label purposes when physicians see fit, including the treatment of panic disorder and diabetic neuropathy. Effexor is currently manufactured by Wyeth Pharmaceuticals, now a division of Pfizer, Inc.

Despite the fact that prescription antidepressant drugs like Effexor are becoming more and more popular in treating depression and a number of other disorders and conditions, recent research may compromise the reputation of these medications. According to a number of studies, women who take certain antidepressant medications while pregnant may significantly increase their risk of giving birth to infants with one or more serious birth defects, including heart defects.

Heart Defects Described

A congenital heart defect is a malformation present at birth involving the structure of the heart or the blood vessels surrounding the heart. These defects are caused by the failure of the heart to form properly during fetal development. Heart defects may disrupt the flow of blood in the heart, cause blood to flow through the heart in an abnormal manner, or cause the heart to have an irregular rhythm. Some heart defects are minor and may never be detected while others require immediate medical treatment, sometimes followed by long-term care. Two of the most common heart defects are atrial septal defects and ventricular septal defects.

Atrial Septal Defects

An atrial septal defect (ASD) is characterized by a hole in the wall of the heart which separates the upper chambers, or atria, caused by the failure of the wall to close completely in utero. Atrial septal defects allow oxygen to pass between the left and right atrium, increasing the amount of blood which flows to the lungs. This increase of pressure in the lungs can cause symptoms like shortness of breath, fatigue, poor growth, poor appetite and frequent lung infections. Without treatment, severe atrial septal defects may lead to additional complications like abnormal heart rhythms and may increase an infant’s chances of suffering from stroke and pulmonary hypertension.

Ventricular Septal Defects

A ventricular septal defect (VSD) is similar to an ASD, but involves a hole in the wall separating the right and left ventricles instead. If the hole in the heart is large, blood may be allowed to flow between the left and right sides of the heart, forcing them to work harder than normal. In addition, the defect may cause excessive blood to flow to the lungs, increasing the pressure in the lungs to a dangerous level. This may result in symptoms like rapid breathing, rapid heartbeat, sweating, decreased feeding and poor weight gain. Without proper medical treatment, an infant with a VSD may suffer from life-threatening complications like aortic regurgitation, endocarditis, and pulmonary hypertension.

Potential Effexor Birth Defects and FDA Warnings

Although the majority of antidepressant birth defect studies have concentrated primarily on SSRI antidepressants, the similarity between these and SNRI antidepressant drugs may allow experts to use these studies to evaluate the dangers potentially associated with SNRIs like Effexor. In 2006, the New England Journal of Medicine published a study in which researchers found a six-times increased risk of PPHN among infants exposed to SSRI antidepressants in utero, compared to unexposed infants. PPHN, or persistent pulmonary hypertension of the newborn, is a potentially fatal birth defect in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. Shortly after this study was released, the FDA issued a public health advisory warning patients and healthcare providers about the potential connection between SSRI antidepressants and PPHN. The FDA has also since required all SSRI sponsors to update their drugs’ warning labels to include potential pregnancy precautions like PPHN.

Another study published in 2010 in the American Journal of Nursing found that infants whose mothers took certain antidepressant medications during the first trimester of pregnancy were nearly twice as likely to be born with heart defects, particularly atrial septal defects and ventricular septal defects. According to researchers, the prevalence of heart defects among exposed infants was 0.9%, compared to a prevalence of 0.5% among unexposed infants.

Additional studies have sought to examine the adverse effects of fetal exposure to antidepressant drugs. In 2007, the NEJM published two studies, the first of which determined that infants exposed to certain antidepressants during the first trimester of pregnancy had nearly twice the risk of developing birth defects like anal atresia, limb defects, and club foot. The study also indicated a possible connection between these antidepressants and neural tube birth defects, cleft palate and cleft lip. The second study discovered that infants born to women who took certain antidepressants while pregnant were more than twice as likely to suffer from life-threatening birth defects like anencephaly, craniosynostosis and omphalocele.

Effexor Use During Pregnancy

Effexor has been classified by the FDA as a pregnancy category C medication, which means the drug may cause serious harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoiding prescribing category C medications like Effexor to pregnant women unless the possible benefits of the drug outweigh the potential risks to the fetus. If you are currently taking Effexor and you are pregnant or planning to become pregnant, consult your healthcare provider as soon as possible. You should never stop taking a prescription medication without medical consent, as this may cause further harm to you or your child. However, with the help of your doctor, you may be able to find a safer way to treat your condition.

Unfortunately, many birth defects are established during the first trimester of pregnancy, before some women are even aware they are pregnant. Because nearly half of all pregnancies are unplanned, all women of childbearing age taking antidepressants like Effexor may be at risk of unknowingly causing irreversible harm to their unborn child.

An Effexor Attorney Can Help

Although some heart defects are not serious and require little to no treatment, statistics show that more than half of all children born with a heart defect require medical treatment, typically surgery. In addition, heart defects are among the most common types of birth defects and are also the leading cause of birth defect-related death among infants. If you or a loved one has suffered from a heart defect and you believe Effexor to be the cause, contact an Effexor attorney to discuss your legal options. You may have grounds to file an Effexor lawsuit against Wyeth Pharmaceuticals (Pfizer) in order to seek financial compensation for your injuries, medical expenses and pain and suffering.

Pharmaceutical companies like Wyeth are responsible for the safety of their medications and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, this isn’t always the case. In fact, some drug companies are aware of the harmful nature of their drugs and intentionally withhold this information from the public in order to ensure their drug is approved and well-received by the public. This puts millions of consumers at risk of unnecessary harm simply by taking their prescription medications. Only by hiring a qualified Effexor lawyer to represent their case can victims of alleged Effexor birth defects protect their rights and collect the compensation they are entitled to.

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