Heart Defects - Consumer Justice Foundation

Heart Defects

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Heart Defects and Prozac

Prozac is one of a group of SSRI antidepressants, also known as selective serotonin reuptake inhibitors, which work by restoring the balance of serotonin in the brain, a neurotransmitter responsible for controlling mood. By doing so, Prozac and other SSRIs can effectively relieve the symptoms of depression and improve certain mood disorders. Prozac has been on the market since it garnered FDA approval in 1987 and is currently manufactured by pharmaceutical company, Eli Lilly and Company. Prozac has been approved for the treatment of major depressive disorder, bulimia nervosa, obsessive-compulsive disorder and panic disorder.

Antidepressant drugs are considered the best-selling medications on the U.S. market, with SSRIs in particular as the most popular type of antidepressant available. As of 2007, Prozac was the third most frequently prescribed antidepressant on the market, after Zoloft and Lexapro, with 22.2 million prescriptions filled. Unfortunately, in recent years, serious concerns have been raised about the safety of SSRIs like Prozac, especially in the treatment of pregnant women. According to a number of studies, women who take Prozac or other SSRIs during pregnancy may significantly increase their risk of giving birth to infants with one or more birth defects, including heart defects.

Heart Defect Symptoms

Heart defects are congenital birth defects affecting the formation of a baby’s heart or the blood vessels surrounding the heart. Heart defects occur when there is a problem during fetal development, and can affect the heart in any number of ways, including obstructing the flow of blood in the heart, interfering with the heart’s rhythm, or causing blood to flow through the heart in an abnormal manner. Some heart defects are minor and require little to no treatment throughout the child’s life; in some cases, the defect may never even be discovered. However, more than half of infants born with a heart defect will require at least one invasive surgery in their lifetime.

Atrial and Ventricular Septal Defects

Atrial and ventricular septal defects are malformations of the heart, characterized by a hole in the wall of the heart separating the right and left atria or ventricles, respectively. An atrial septal defect (ASD) allows blood to flow between the left and right sides of the heart; if too much blood moves into the right side of the heart, an increase in pressure in the lungs may occur, which can cause serious complications. Common symptoms of an ASD include shortness of breath, a heart murmur, fatigue, cyanosis (bluish tint to the skin), frequent lung infections, and stroke. A ventricular septal defect (VSD) is a hole which allows oxygen-rich blood to flow from the left ventricle into the right ventricle instead of flowing out to the body as it should. Children born with a VSD may suffer from symptoms like rapid breathing, rapid heart rate, shortness of breath, failure to gain weight, sweating while feeding, and chronic respiratory infections. Without prompt treatment, large septal heart defects can lead to life-threatening side effects like pulmonary hypertension, stroke, and heart failure.

Prozac Birth Defect Studies and FDA Warnings

In 2010, the American Journal of Nursing published a side effect study in which researchers sought to examine the potential connection between fetal exposure to SSRIs like Prozac during the first trimester of pregnant and the development of heart defects, particularly atrial septal defects and ventricular septal defects. According to researchers, the prevalence of septal heart defects among infants exposed to an SSRI like Prozac was 0.9%, nearly twice the prevalence among unexposed infants, which was 0.5%. The study also indicated that the risk of heart defects was even higher among infants whose mothers took more than one SSRI while pregnant.

In 2006, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of persistent pulmonary hypertension of the newborn (PPHN) among infants exposed to Prozac in utero. This notice came on the heels of a New England Journal of Medicine study published that same year in which researchers found a potential connection between fetal exposure to SSRIs like Prozac and a six-times increased risk of PPHN. PPHN is a life-threatening birth defect in which an infant’s circulation continues to bypass the lungs after birth, preventing the rest of the body from receiving the oxygen it needs. This study also led the FDA to require all SSRI sponsors to change prescribing information to include the potential risk of PPHN.

Prozac and Pregnancy

The FDA has labeled Prozac a pregnancy category C medication, a category reserved for drugs with the potential to cause serious harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing Prozac to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus. If you are currently taking Prozac and you are pregnant or planning to become pregnant, consult your healthcare provider immediately. It may be dangerous to suddenly terminate use of a prescription medication, but your doctor may be able to suggest a safer course of treatment.

Contact a Prozac Attorney for Legal Help

Heart defects occur in approximately nine out of every 1,000 births, and are also the leading cause of birth defect-related death among infants in the United States. If you or a loved one has suffered from a heart defect side effect, which you believe to be linked to Prozac, contact an experienced Prozac attorney to discuss the benefits of filing a Prozac lawsuit against Eli Lilly. The main goal of Prozac lawsuits and potential Prozac class action lawsuits is to seek financial compensation for your injuries and medical expenses, as well as the pain and suffering endured by you and your family. Defective drug lawsuits also bring public attention to the importance of safe medications and the need for more stringent regulations on the dangerous drugs already on the market.

Following a birth defect diagnosis, the families of victims should be given adequate time to concentrate on caring for their child, without having to worry about filing a Prozac lawsuit as well. Fortunately, Prozac lawyers are experienced in defective drug litigation and will work their hardest to ensure victims of alleged Prozac birth defects receive a fair settlement or damages for their injuries. Prozac attorneys also have access to what may prove to be critical components of your case, including medical records, insurance documents, and the professional testimonies of medical and scientific experts. With the help of a Prozac lawyer, you can feel confident that your case is in good hands and you can collect the compensation you deserve.

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