Heart Defects - Consumer Justice Foundation

Heart Defects

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Heart Defects and Lexapro

Lexapro is one of a group of prescription antidepressant drugs called SSRIs, or selective serotonin reuptake inhibitors. These medications were originally developed as the primary treatment method for individuals with depression, but have since been approved for additional purposes by the FDA. Lexapro, for example, initially garnered FDA approval in 2002 and is currently approved as a treatment for major depressive disorder and generalized anxiety disorder. The active ingredient in Lexapro is escitalopram, and the drug works by restoring the balance of serotonin, a neurotransmitter in the brain responsible for controlling mood. By doing so, Lexapro and other SSRIs can effectively relieve depression and improve certain mood disorders. Lexapro is currently manufactured by Forest Laboratories, and is considered to be one of the most widely-prescribed antidepressants on the market.

Unfortunately, there have been significant concerns recently about the safety of Lexapro, especially for treatment in pregnant women. According to a number of credible journals like the New England Journal of Medicine and the American Journal of Nursing, women who take SSRIs like Lexapro during pregnancy may significantly increase their risk of giving birth to infants with one or more major birth defects, including heart defects. Regrettably, as estimated by the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressants like Lexapro in the United States in any given year.

Heart Defects Described

Heart defects are malformations present at birth which affect the structure of the heart and/or the blood vessels surrounding the heart. Some heart defects obstruct the flow of blood in the heart while others cause blood to flow through the heart in an abnormal manner. While many heart defects are minor and require little to no treatment, more than half of children born with a heart defect require immediate medical care, sometimes followed by long-term treatment. Heart defects are extremely serious; unfortunately, cardiovascular malformations are one of the most common birth defects and are also the leading cause of birth-defect related death among infants.

Atrial and Ventricular Septal Defects

Both atrial septal defects (ASD) and ventricular septal defects (VSD) are characterized by a hole in the wall of the heart separating the atria and the ventricles, respectively. ASDs allow oxygenated blood from the left atria to mix with oxygen-poor blood from the right atria, causing an excessive amount of blood to be pumped to the lungs. Symptoms of atrial septal defects include difficulty breathing, shortness of breath, heart palpitations and frequent respiratory infections. Some ASDs are small and may never be detected, while others are large and may lead to life-threatening complications like heart failure, pulmonary hypertension, stroke and even death. In children with a VSD, blood is allowed to flow between the right and left ventricles, causing them to work harder than normal and potentially leading to heart failure. Common symptoms of a ventricular septal defect include poor weight gain, decreased feeding, sweating, rapid breathing and rapid heart rate. Without treatment, a VSD may result in dangerous conditions like pulmonary hypertension, endocarditis or aortic regurgitation.

Hypoplastic Left Heart Syndrome

Hypoplastic left heart syndrome is a rare type of congenital heart disease, occurring when portions of the left side of the heart fail to form completely during fetal development. In children with HLHS, lack of growth of the left ventricle and other structures prevents the left side of the heart from sending a sufficient amount of blood to the rest of the body. This forces the right side of the heart to maintain the circulation for both the lungs and the body, eventually causing the right side of the heart to fail. Common symptoms of hypoplastic left heart syndrome include shortness of breath, poor pulse, poor feeding, cyanosis (bluish tint to the skin), lethargy, and pounding heart. Without treatment, HLHS is fatal; even with treatment, the child may suffer from complications like heart failure, heart arrhythmias, chronic diarrhea, stroke, fluid in the abdomen and lungs, or sudden death.

Shone’s Complex

Shone’s complex is a type of heart disease present at birth in which a child suffers from multiple malformations, interfering with the flow of blood from the left side of the heart to the rest of the body. This condition occurs when the heart fails to develop properly in utero, potentially resulting in life-threatening complications. Although some infants with Shone’s complex may be asymptomatic at birth, few affected children remain that way for long. Symptoms of this defect typically appear in early childhood, and include fatigue, shortness of breath, poor oral intake, heart murmur, recurring respiratory infections, paleness, weight gain from water retention, and swelling in the lower extremities. The prognosis for children with Shone’s complex is poor; even with surgery to correct the associated malformations, many affected infants suffer from catastrophic events like stroke, heart failure, infection or heart block.

Lexapro Birth Defect Studies and FDA Warnings

One of the most recent SSRI birth defect studies was published in 2010 in the American Journal of Nursing. This study indicated that infants exposed to an SSRI like Lexapro in utero were nearly twice as likely to develop severe heart defects, particularly atrial septal defects or ventricular septal defects. According to researchers, the prevalence of septal heart defects among infants exposed to an SSRI was 0.9%, compared to the prevalence among unexposed infants, which was 0.5%.

In 2006 the FDA issued a public health advisory, warning patients and healthcare providers about the increased risk of persistent pulmonary hypertension (PPHN) among infants exposed to SSRI drugs like Lexapro in utero. PPHN is a serious birth defect in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen and blood. This FDA decision was directly influenced by a New England Journal of Medicine study published earlier that year in which researchers found a six-times increased risk of PPHN among infants whose mothers took an SSRI after the twentieth week of pregnancy. According to the report, up to twelve out of 1,000 infants exposed to an SSRI like Lexapro during the third trimester of pregnancy were born with PPHN, compared to the expected rate among the general population, which is one to two infants out of 1,000.

In 2007, the NEJM published two additional studies in which researchers sought to examine the potential connection between SSRI antidepressants and serious birth defects. In the first study, infants born to women who took an SSRI during the first trimester of pregnancy were nearly twice as likely to develop birth defects like anal atresia, club foot and limb defects. Researchers also found a possible link between these drugs and cleft lip, neural tube birth defects and cleft palate. According to the second study, infants whose mothers took an SSRI like Lexapro while pregnant were more than twice as likely to be born with a catastrophic birth defect like anencephaly, omphalocele or craniosynostosis.

Lexapro Use While Pregnant

Lexapro has been labeled by the FDA as a pregnancy category C medication, which means it has the potential to cause serious harm to a fetus when taken during pregnancy. The FDA has advised physicians to avoid prescribing Lexapro to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus. If you are currently taking Lexapro and you are pregnant or planning to become pregnant, consult your healthcare provider immediately. It may be dangerous to suddenly discontinue use of a prescription medication, but with your doctor’s help you may be able to find a safer alternative to Lexapro for treating your medical condition.

A Lexapro Attorney Can Help

Birth defects can severely inhibit the development of a child, sometimes resulting in devastating intellectual dysfunction, physical disability, and even death. Unfortunately, not all birth defects can be treated and cured, and those that can be treated successfully often impose a significant financial burden on the victim and his family. If you or a loved one has suffered from a heart defect and you believe Lexapro to be the cause, contact a Lexapro attorney to discuss your legal options. You may be entitled to reimbursement for your injuries and medical expenses, which you can collect by filing a Lexapro lawsuit against manufacturing company, Forest Laboratories.

Filing a Lexapro lawsuit can be a complicated process. Fortunately, Lexapro lawyers are experienced in defective drug litigation, and can help injury victims through the necessary steps. Following a birth defect diagnosis, victims and their families deserve to be given adequate time to concentrate on seeking proper medical care without having to worry about compiling evidence to support their potential case. With the help of a qualified Lexapro attorney, victims can feel confident that their case is being professionally and effectively represented. By filing a Lexapro lawsuit, victims of alleged Lexapro birth defects can protect their rights and collect the compensation they deserve, while simultaneously bringing public attention to the importance of safe medications and the need for more strict regulations on the dangerous drugs already on the market.

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