Omphalocele - Consumer Justice Foundation


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Omphalocele and Lexapro

Lexapro (escitalopram) is a prescription antidepressant medication manufactured by Forest Laboratories and used in the treatment of major depressive disorder and generalized anxiety disorder. Lexapro belongs to a class of antidepressants known as SSRIs, or selective serotonin reuptake inhibitors, which work by increasing the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Serotonin is a neurotransmitter in the brain which is responsible for controlling mood. Lexapro was originally approved by the FDA in 2002 and has quickly become one of the most commonly prescribed antidepressants on the market. However, despite the popularity of Lexapro and other SSRIs, these drugs have become the subject of significant scrutiny in recent years, as studies have surfaced which detail the potentially harmful nature of these medications in the treatment of pregnant women. According to a number of studies, women who take SSRIs like Lexapro during pregnancy may significantly increase their risk of giving birth to infants with life-altering birth defects like omphaloceles. Unfortunately, the Journal of the American Medical Association estimates that over 80,000 pregnant women are prescribed SSRIs like Lexapro in the United States in any given year.

Omphaloceles Described

An omphalocele is a congenital birth defect characterized by the failure of the abdominal muscles to close completely during fetal development. In children with an omphalocele, the abdominal contents may protrude from the naval, protected only by a thin layer of tissue. In less severe cases, only the intestines may be involved, while larger defects may include the liver and spleen as well.

Omphalocele Treatment and Complications

It is estimated that 25-40% of infants born with an omphalocele suffer from additional birth defects, particularly heart defects. Treatment for an omphalocele involves surgery to repair the malformation, although more pressing matters, like heart defects, can typically be treated first if necessary. During surgery, a man-made material is placed over the defect, allowing the abdominal contents to be pushed back into place over time. Once this is complete, the artificial material can be removed and the abdomen can be closed. However, if the defect is too large for this procedure to be performed, the skin around the defect will be left to grow and eventually cover the malformation. Later in life, the abdominal muscles and skin can be repaired in order to correct the appearance of the abdomen.

Alleged Lexapro Birth Defects and FDA Warnings

In 2006, the New England Journal of Medicine published a study in which researchers sought to examine the adverse effects of SSRI antidepressants on infants exposed to the drugs in utero. According to this study, infants whose mothers took an SSRI like Lexapro after the twentieth week of pregnancy were an alarming 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 serious heart and lung defect in which a child’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. The report indicated that up to twelve out of 1,000 exposed infants were born with PPHN, compared to the rate among the general population, which is one to two out of 1,000 infants. In response to this study, the FDA issued a safety announcement, warning patients and healthcare providers about the increased risk of PPHN among infants exposed to an SSRI in utero. The FDA also required all SSRI sponsors to change prescribing information to include the potential risk for PPHN.

A year later, the NEJM published two additional studies, the first of which found that women who took an SSRI like Lexapro during the first trimester of pregnancy were nearly twice as likely to give birth to infants with birth defects like limb defects, club foot and anal atresia. Researchers also found a possible connection between SSRIs and cleft lip, cleft palate and neural tube birth defects. According to the second study, infants born to women who took an SSRI like Lexapro while pregnant were more than twice as likely to develop devastating birth defects like omphalocele, craniosynostosis and anencephaly. In 2010, the American Journal of Nursing published another SSRI birth defect study in which researchers found fetal exposure to SSRIs to be associated with a nearly two-times increased risk of serious heart defects, particularly atrial and ventricular septal defects.

Lexapro Use and Pregnancy

The FDA has classified Lexapro as a pregnancy category C medication, which means the drug has the potential to cause harm to a human fetus when taken during pregnancy. If you are currently taking Lexapro and you are pregnant or planning to become pregnant, consult your physician immediately. It is never advised to terminate use of a prescription medication without medical consent, but with your doctor’s help, you may be able to find an alternative treatment option.

Contact a Lexapro Attorney for Help

Despite the potential dangers associated with Lexapro use during pregnancy, the drug remains on the market today available to millions of consumers, including pregnant women. If you or a loved one has suffered from an omphalocele and you believe Lexapro to be the cause, contact a Lexapro attorney to discuss the benefits of filing a Lexapro lawsuit against Forest Laboratories. The goal of Lexapro lawsuits and potential Lexapro class action lawsuits is to seek financial compensation for your injuries, medical expenses, and pain and suffering. Lexapro lawyers are well-versed in defective drug litigation and can help victims of alleged Lexapro birth defects collect the compensation they deserve. Seeking proper care for a birth defect can result in costly medical bills, which can be an overwhelming financial burden for a family already emotionally compromised by a birth defect diagnosis. After a birth defect has been diagnosed, the families of birth defect victims should be given adequate time to concentrate on caring for their child without having to worry about filing a birth defect lawsuit as well. With the help of an experienced Lexapro attorney, you can feel confident that your case is in good hands and the rights of you and your child are being protected.

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