Zoloft is one of a group of prescription antidepressant medications known as SSRIs, or selective serotonin reuptake inhibitors. These drugs work by restoring the balance of serotonin in the brain, a neurotransmitter responsible for affecting mood. By doing so, these drugs can effectively relieve depression and improve certain mood disorders. Zoloft (sertraline) was approved by the FDA in 1991 and has since been used to treat individuals suffering from major depression, social anxiety disorder, post-traumatic stress disorder, panic disorder, premenstrual dysphoric disorder and obsessive-compulsive disorder. As of 2007, Zoloft was the most frequently prescribed antidepressant on the U.S. market with 29.7 million prescriptions filled.
Regardless of the popularity of Zoloft and other SSRI antidepressants, recent research has raised significant concerns regarding the safety of these drugs, especially in treating pregnant women. According to a number of studies, women who take SSRIs like Zoloft while pregnant may significantly increase their chances of giving birth to infants with one or more major birth defects, including neural tube birth defects.
Neural tube birth defects occur when the neural tube fails to close completely during fetal development. The neural tube is a fetal structure which is present during the early stages of pregnancy and will become the foundation for the child’s central nervous system. A neural tube birth defect is characterized by an opening in the spinal column or skull, resulting from the failure of the neural tube cells to fuse together completely in utero. This type of defect is especially dangerous because it is often accompanied by damage to the brain and spinal cord as well, leading to problems with development, learning and movement. Neural tube birth defects can be devastating, leading to complications like paralysis, incontinence, muscle weakness, loss of sensation in parts of the body, lack of concentration, lack of coordination, stiff joints, difficulty solving problems and chronic allergies.
Spina bifida is one of the most common types of neural tube defects, characterized by the failure of the vertebrae overlying the spinal cord to fuse together properly. This defect creates an opening in the spinal column through which the spinal cord may actually protrude. There are two types of spina bifida, spina bifida occulta and spina bifida cystica, which vary greatly in severity. Spina bifida occulta, the most common and least severe form of spina bifida, is typically difficult to diagnose because of the lack of symptoms exhibited by affected children. In most cases, the only visible sign of the malformation is a small birthmark or patch of hair at the actual site of the defect. Spina bifida cystica, on the other hand, is an extremely serious condition, characterized by a fluid-filled cyst which protrudes from the child’s back and contains the spinal cord, nerves, or both.
Anencephaly is a devastating neural tube birth in which a child is born without critical parts of the brain and skull. This malformation occurs when the head end of the neural tube fails to close completely in utero, resulting in the absence of the forebrain, the largest part of the brain, and the cerebrum, which is responsible for movement, thinking and senses. Infants with anencephaly are typically born deaf, blind, unconscious and unable to feel pain. Although some children may display reflex actions like breathing and response to touch, the lack of a functioning cerebrum makes it impossible for the child to ever regain consciousness. There is no cure for anencephaly, and children born with this birth defect typically only survive for a few hours or days after birth.
In 2006, the FDA issued a public health advisory warning patients and healthcare providers about the connection between PPHN and fetal exposure to SSRI antidepressants like Zoloft. The FDA also required all sponsors of SSRIs to change prescribing information to reflect the potential risk for PPHN. These FDA decisions were directly influenced by new information provided by a New England Journal of Medicine study published earlier that year. According to the study, infants born to women who took an SSRI like Zoloft after the twentieth week of pregnancy were a shocking six times more likely to develop PPHN, compared to infants whose mothers took no antidepressants while pregnant. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening heart and lung condition in which a child’s circulation continues to bypass the lungs after birth, depriving the body’s organs and tissues of oxygen.
In 2007, the NEJM published two additional studies in which researchers sought to examine the adverse effects of SSRI antidepressant medications on infants exposed to the drugs during pregnancy. The first study indicated 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, anal atresia and limb defects. Researchers also found a potential connection between these drugs and neural tube birth defects, cleft palate and cleft lip. According to the second study, infants born to women who took an SSRI while pregnant were more than twice as likely to develop catastrophic birth defects like anencephaly, omphalocele and craniosynostosis. In 2010, the American Journal of Nursing published a study in which researchers found a connection between fetal exposure to SSRIs during the first trimester of pregnancy and a nearly two-fold increased risk of heart defects among infants. According to the report, the prevalence of atrial and ventricular septal defects was 0.9% among exposed infants, compared to 0.5% among unexposed infants.
Zoloft has been labeled by the FDA as a pregnancy category C medication, which means it may cause serious harm to a human fetus when taken during pregnancy. The FDA has advised physicians to avoid prescribing category C medications to pregnant women unless 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 terminate use of a prescription medication, as this may cause further harm to you or your child, but with your doctor’s help you may be able to find a safer way to treat your condition.
Extensive research has suggested that the use of SSRI antidepressants during pregnancy may significantly increase an infant’s risk of being born with serious birth defects. Despite these alarming findings, Zoloft and other SSRIs are still being prescribed to pregnant women and women of childbearing age across the country. In fact, according to the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressants like Zoloft in the United States in any given year. If you or a loved one has suffered from a neural tube birth defect and you believe Zoloft to be the cause, contact a Zoloft attorney as soon as possible to discuss your legal options. You may be entitled to reimbursement for your injuries and medical expenses, which you can collect by filing a Zoloft lawsuit against Pfizer.
Unfortunately, the majority of birth defects are already established during the first trimester of pregnancy, before many women are even aware they are pregnant. Furthermore, statistics show that nearly half of all pregnancies are unplanned. This means that all women of childbearing age taking Zoloft or other SSRI antidepressants may be at risk of unknowingly causing irreversible harm to their unborn child. Victims of serious injury resulting from the proper use of a potentially dangerous drug are not at fault. Drug manufacturing companies are responsible for the safety and effectiveness of their medications, and should be held accountable for any adverse side effects sustained by consumers of their products. Unfortunately, some pharmaceutical companies intentionally deny liability for dangerous drug injuries in an attempt to protect themselves from negative consequences, such as a drug recall. Not only does this deceptive practice prevent victims from collecting the compensation they deserve, but it also exposes millions of other consumers to serious injury and death, simply by taking their prescription medications. Only by contacting a qualified Zoloft lawyer to represent their case can victims of alleged Zoloft birth defects feel confident that their case is in good hands.
