Omphalocele - Consumer Justice Foundation


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Effexor and Omphalocele

Effexor is one of a group of prescription antidepressant medications called SNRIs, or serotonin-norepinephrine reuptake inhibitors, which function by inhibiting the “reuptake” of serotonin and norepinephrine, two neurotransmitters in the brain responsible for affecting mood. These drugs differ only slightly from SSRIs, or selective serotonin reuptake inhibitors, which were developed before SNRIs and act upon serotonin alone to relieve depression and improve certain mood disorders. The active ingredient in Effexor is venlafaxine and the drug was approved by the FDA in 1993 for the treatment of major depressive disorder, social anxiety disorder and generalized anxiety disorder. Although these are its only approved uses, the drug is also often prescribed for off-label purposes including the treatment of panic disorder and diabetic neuropathy. Effexor is currently manufactured by Wyeth Pharmaceuticals, now a division of pharmaceutical giant, Pfizer, Inc.

In recent years, a number of studies have been conducted in an attempt to establish the potential adverse effects of antidepressants on infants exposed to the drugs during pregnancy. According to this body of research, women who take certain antidepressant medications while pregnant may significantly increase their chances of giving birth to infants with serious birth defects, including omphalocele. Unfortunately, many birth defects are established during the first trimester of pregnancy, before many women are even aware they are pregnant. Because nearly half of all pregnancies are unplanned, all women of childbearing age who take antidepressants like Effexor may be at risk of unknowingly causing catastrophic harm to their unborn child.

Omphalocele Described

An omphalocele is a congenital birth defect in which a child’s abdominal contents protrude from the naval. This malformation is caused by the failure of the abdominal muscles to form properly during fetal development, allowing the intestines and sometimes the liver and spleen to remain outside the umbilical cord. These organs are typically protected only by a thin layer of tissue and can easily be seen with the naked eye.

Omphalocele Treatment and Complications

Omphaloceles are repaired with the help of reconstructive surgery, during which a man-made material is placed over the defect and stitched into place. Over time, the abdominal contents will be pushed back into place, after which the artificial material can be removed and the abdomen can be closed. In instances in which the omphalocele is too large for this procedure to be successful, the skin will eventually grow around and cover the defect. The skin and abdominal muscles can then be repaired later in life in order to repair the appearance of the abdomen. Unfortunately, it is estimated that 25-40% of children with an omphalocele are born with additional birth defects, usually heart defects. Some infants born with an omphalocele may also suffer from intestinal infection and death of the intestinal tissue.

Alleged Effexor Birth Defects

In 2006, the New England Journal of Medicine published a study in which researchers found a six-times increased risk of PPHN among infants whose mothers took SSRI antidepressants after the twentieth week of pregnancy. PPHN, or persistent pulmonary hypertension of the newborn, is a life-threatening condition in which an infant’s circulation continues to bypass the lungs after birth, depriving the body of oxygen. Two other studies were published by the NEJM in 2007, the first of which suggested that infants exposed to certain antidepressant drugs during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like anal atresia, limb defects and club foot. Researchers also found a connection between these drugs and cleft palate, neural tube birth defects and cleft lip. According to the second study, infants exposed to these antidepressants in utero were more than twice as likely to suffer from devastating birth defects like anencephaly, craniosynostosis and omphalocele. In 2010, the American Journal of Nursing published a study which indicated that infants born to women who took certain antidepressant drugs while pregnant were nearly twice as likely to suffer from serious heart defects, namely atrial and ventricular septal heart defects.

Effexor Use During Pregnancy and FDA Warnings

Effexor has been labeled a pregnancy category C medication by the FDA, which means the drug has the potential to cause serious harm to a fetus when taken during pregnancy. If you are currently taking Effexor and you are pregnant or planning to become pregnant, consult your physician to discuss alternative treatment options. It may be dangerous to discontinue use of a prescription medication without medical consent, but with your doctor’s help you may be able to find a safer alternative to Effexor for treating your condition.

In response to the 2006 NEJM study, the FDA issued a public health advisory warning patients and healthcare providers about the potential connection between SSRI antidepressants and PPHN. The FDA has also since required all SSRI sponsors to update their drug warning labels to include potential pregnancy precautions, including PPHN.

An Effexor Attorney Can Help

Proper treatment for children with an omphalocele can lead to exorbitant medical expenses, which can be an overwhelming financial burden for families already emotionally distressed by a birth defect diagnosis. Furthermore, omphaloceles are often accompanied by additional birth defects which may cause even more severe complications for an affected child. If you or a loved one has suffered from an omphalocele and you believe Effexor to be the cause, contact an Effexor attorney to discuss the benefits of filing an Effexor lawsuit against Wyeth Pharmaceuticals (Pfizer). The goal of Effexor lawsuits and potential Effexor class action lawsuits is to seek financial compensation for your injuries, the medical expenses associated with treating the injuries, and the pain and suffering endured by you and your family.

You are not at fault for any adverse side effects caused by the proper use of a potentially dangerous drug. Drug manufacturing companies like Wyeth are responsible for the safety of their medications even after they enter the market, and are expected to alert the public of any dangers potentially associated with their products. Unfortunately, some pharmaceutical companies intentionally conceal this information in order to avoid negative consequences, such as a drug recall. This puts millions of consumers at risk of suffering serious injury, illness and even death, which could have been avoided had the drug company taken the appropriate steps to avoid unnecessary harm. The only way for victims of alleged Effexor birth defects to protect their rights and collect the compensation they deserve is to hire a qualified Effexor lawyer to represent their case. Defective drug litigation can be a complicated process, but with the help of an Effexor attorney, victims can feel confident that their case is in good hands.

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