Omphalocele - Consumer Justice Foundation


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Zoloft and Omphalocele Birth Defects

Zoloft belongs to a class of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. These drugs function by increasing the level of serotonin in the brain, a neurotransmitter responsible for affecting mood, thereby relieving depression and improving certain mood disorders. Zoloft was approved by the FDA in 1991 and has since been prescribed to individuals suffering from major depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder. The active ingredient in Zoloft is sertraline and the drug is currently manufactured by Pfizer, Inc.

Despite the fact that Zoloft was considered the most frequently prescribed antidepressant on the market in 2007, with 29.7 million prescriptions filled, recent research has suggested that these drugs may not be safe, especially in the treatment of pregnant women. According to a number of studies, women who take Zoloft while pregnant may significantly increase their chances of giving birth to an infant with one or more major birth defects, including an omphalocele. Unfortunately, according to the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressant medications like Zoloft in the United States in any given year.

Omphalocele Described

An omphalocele is a congenital birth defect in which a child’s abdominal muscles fail to develop properly in utero, causing the abdominal contents to protrude from the naval. In cases where the defect is small, only the intestines may remain outside the umbilical cord, while more severe instances may involve the liver and spleen as well. The abdominal contents are typically protected only by a thin layer of tissue and can easily be seen with the naked eye.

Omphalocele Treatment and Prognosis

Children born with an omphalocele typically require reconstructive surgery in order to correct the defect and restore the appearance and function of the abdomen. During this procedure, a man-made material is stitched in place over the abdomen which pushes the abdominal contents back into place over time. Once this occurs, the artificial material can be removed and the abdomen can be closed. In some cases, the omphalocele may be too large for this procedure to be conducted, in which case the skin will be allowed to grow and cover the defect. The skin and abdominal muscles can then be repaired later in life. Most children with this birth defect make a full recovery after surgery. However, even with treatment, some affected infants will still suffer from complications like intestinal infection and death of the intestinal tissue.

Zoloft Birth Defect Studies and FDA Warnings

The FDA issued a public health advisory in 2006, warning patients and healthcare providers about the increased risk of PPHN among infants exposed to SSRI antidepressants like Zoloft during pregnancy. The FDA also required all sponsors of SSRI antidepressants to change prescribing information to include the potential risk for PPHN. These FDA notices were issued in response to a study published in the New England Journal of Medicine in 2006, in which researchers found that fetal exposure to SSRIs during the third trimester of pregnancy increased an infant’s risk of developing PPHN by an alarming six times. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening heart and lung condition in which an infant’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. According to researchers involved in the study, up to twelve out of 1,000 infants exposed to an SSRI in utero were born with PPHN, compared to the rate among the general population, which is one to two out of 1,000 infants.

In 2007, the NEJM published two additional studies in which researchers sought to examine the adverse effects of SSRI antidepressants on infants exposed to the drugs during pregnancy. According to the first study, infants whose mothers took an SSRI antidepressant like Zoloft during the first trimester of pregnancy were nearly twice as likely to develop birth defects like club foot, limb defects and anal atresia. Researchers also found a possible connection between SSRIs and cleft palate, cleft lip and neural tube birth defects. The second study indicated that infants born to women who took an SSRI 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 determined that infants exposed to SSRIs like Zoloft during the first trimester of pregnancy were nearly twice as likely to be born with serious heart defects, like atrial septal defects and ventricular septal defects.

Zoloft Use While Pregnant

Zoloft has been labeled by the FDA as a pregnancy category C medication, which means it has the potential to cause serious harm to a human fetus when taken during pregnancy. If you are currently taking Zoloft and you are pregnant or planning to become pregnant, consult your physician to discuss alternative treatment options. 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 way to treat your condition.

A Zoloft Attorney Can Help

Unfortunately, approximately 25-40% of infants born with an omphalocele struggle with additional birth defects, particularly heart defects, which can cause severe complications for an affected child. If you or a loved one has suffered from an omphalocele and you believe Zoloft to be the cause, contact a Zoloft attorney as soon as possible. You may be entitled to reimbursement for your injuries and medical expenses, which you can collect by filing a Zoloft lawsuit against Pfizer. Besides seeking financial compensation, 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.

Victims of serious injuries resulting from the proper use of a dangerous drug are not at fault and should not be held responsible for the resulting consequences. Drug manufacturing companies companies like Pfizer are expected to produce and market safe 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 drug injuries in order to avoid negative consequences, such as a drug recall. Other drug companies are aware of the harmful nature of their products and withhold this information in order to expedite the FDA approval process and ensure their drug is well-received by the public. This deceptive practice puts millions of consumers at risk of suffering serious injury, illness and even death, tragedies which could have been avoided had the drug company taken the appropriate steps to avoid unnecessary harm. The only way to protect your rights and receive the compensation you deserve is to hire a qualified Zoloft lawyer to represent your case.

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