Zoloft is one of a group of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. These drugs function by restoring the level of the neurotransmitter, serotonin, in the brain, subsequently relieving depression and improving certain mood disorders. Zoloft was approved by the FDA in 1991 and has since been used in the treatment of major depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder and premenstrual dysphoric disorder. Zoloft (sertraline) is currently manufactured by Pfizer, Inc. and is considered one of the most widely prescribed antidepressants on the U.S. market.
Despite the fact that Zoloft has become increasingly popular in recent years, the results of a number of credible medical studies have raised concerns about the safety of this drug and others of its kind, especially in treating pregnant women. According to an emerging body of research, women who take SSRI antidepressants like Zoloft while pregnant may significantly increase their chances of giving birth to infants with major birth defects, including heart defects.
A heart defect is a type of congenital birth defect which involves a malformation of the heart or the blood vessels surrounding the heart. Some heart defects may obstruct the flow of blood in the heart, while others may cause blood to flow through the heart in an irregular pattern or affect the heart’s rhythm. While some heart defects are minor and can remain untreated, more than half of the infants born with a heart defect will require treatment in order to prevent further complications. Some of these children will also require long-term medical care in order to monitor development and prevent further complications. The symptoms associated with heart defects depend largely upon the type and severity of the malformation. Two of the most common types of heart defects are atrial septal defects and ventricular septal defects, both of which are characterized by a hole in the wall of the heart.
An atrial septal defect (ASD) is a defect of the heart caused by the failure of the wall separating the upper chambers of the heart (atria) to close completely in utero. This results in a hole through which blood can flow between the left and right atria, allowing an excessive amount of blood to flow to the lungs. Common symptoms of an ASD include shortness of breath, fatigue, poor growth, poor appetite, and frequent lung infections. In some cases, the defect may be small and may require little to no treatment. Large defects however, can lead to dangerous complications like abnormal heart rhythms, and can also increase a child’s risk of suffering from life-threatening conditions like pulmonary hypertension and stroke.
A ventricular septal defect (VSD) is similar in nature to an ASD, but is characterized by a hole in the wall separating the ventricles instead. A VSD allows blood to flow between the left and right ventricles, causing them to work harder than normal and potentially leading to heart failure. This type of defect may also allow an excessive amount of blood to flow to the lungs, resulting in a dangerous increase in pressure in the lungs. Common symptoms of a ventricular septal defect include rapid breathing, sweating, rapid heart rate, decreased feeding and poor weight gain. Without prompt diagnosis and treatment, children with a severe VSD may suffer from serious complications, including endocarditis, pulmonary hypertension and aortic regurgitation.
The New England Journal of Medicine published a study in 2006 in which researchers found a six-times increased risk of PPHN among infants exposed to SSRI antidepressants like Zoloft during the third trimester of pregnancy. PPHN, or persistent pulmonary hypertension of the newborn, is a severe birth defect in which a newborn’s circulation continues to bypass the lungs after birth, depriving the rest of the body of oxygen. According to this study, up to twelve out of 1,000 infants exposed to an SSRI after the twentieth week of pregnancy were born with PPHN, compared to the rate among the general population, which is one to two out of 1,000 infants. Shortly after this study was released, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRIs during pregnancy. The FDA also required all SSRI sponsors to change prescribing information to include the potential risk for PPHN.
In 2007, the NEJM published two additional studies, the first of which determined that infants whose mothers took an SSRI like Zoloft during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like club foot, limb defects and anal atresia. Researchers also found a potential connection between SSRI drugs and cleft palate, cleft lip and neural tube birth defects. According to the second study, infants exposed to an SSRI like Zoloft during pregnancy were more than twice as likely to develop catastrophic birth defects like anencephaly, craniosynostosis and omphalocele.
In 2010, the American Journal of Nursing published a revealing study in which researchers found a nearly two-fold increased risk of serious heart defects, particularly atrial and ventricular septal defects, among infants exposed to SSRI drugs in utero. According to the study, the prevalence of septal heart defects was 0.9% among infants exposed to an SSRI during pregnancy, compared to the prevalence among unexposed infants, which was 0.5%.
Zoloft has been classified by the FDA as a pregnancy category C medication, which means the drug may cause serious harm to a human fetus when taken during pregnancy. According to the FDA, category C medications like Zoloft should only be taken during pregnancy if the possible benefits of the treatment outweigh the potential risks to the fetus. If you are currently taking Zoloft and you are pregnant or planning to become pregnant, consult your physician as soon as possible. You should never suddenly stop taking a prescription medication, as this may cause further harm to you or your child. However, with the aid of your doctor, you may be able to find a safer alternative to Zoloft for treating your medical condition.
Not only are heart defects one of the most common types of birth defects, but they are also the leading cause of birth defect-related death among infants. If you or a loved one has suffered from a heart defect which you believe to be associated with the use of Zoloft, contact a Zoloft attorney to discuss the benefits of filing a Zoloft lawsuit against Pfizer. The goal of Zoloft lawsuits and potential Zoloft class action lawsuits is to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by you and your family. Defective drug lawsuits also bring attention to the hazardous nature of certain drugs, potentially preventing dangerous drug injuries in the future.
Consumers expect their prescription medications to effectively treat their condition without causing them any unreasonable harm. They also expect to be notified immediately of any dangers associated with their medications, so that they can make an educated decision to continue or discontinue use of the drug. Unfortunately, some pharmaceutical companies intentionally withhold dangerous drug information in order to expedite the FDA approval process and to ensure their product is well-received by the public. This deceptive practice puts millions of consumers at risk of suffering life-altering injuries and even death, simply by taking their prescription medications. Only by hiring a qualified Zoloft lawyer can victims of alleged Zoloft birth defects protect their rights and collect the compensation they deserve. Defective drug litigation can be a complicated process, but with the help of an experienced Zoloft attorney, injury victims can feel confident that their case is in good hands.