Omphalocele - Consumer Justice Foundation


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Omphalocele and Prozac

Prozac falls into the category of selective serotonin reuptake inhibitor, a type of antidepressant medication more commonly called an SSRI. SSRI antidepressants work by restoring the balance of a neurotransmitter in the brain called serotonin, thereby relieving depression and improving certain mood disorders. Prozac has been on the market since it was approved by the FDA in 1987, and is commonly prescribed for the treatment of major depressive disorder, bulimia nervosa, panic disorder and obsessive-compulsive disorder. The active ingredient in Prozac is fluoxetine, and the drug is currently manufactured by pharmaceutical company, Eli Lilly and Company.

SSRI antidepressants are considered one of the best-selling medications on the U.S. market. As of 2007, Prozac was the third most commonly prescribed antidepressant available, behind only Zoloft and Lexapro, with 22.2 million prescriptions filled. Unfortunately, an emerging body of research has indicated that Prozac and other SSRI drugs may no longer be considered safe, especially in the treatment of pregnant women. According to a number of SSRI side effect studies, women who take SSRIs like Prozac during pregnancy may significantly increase their risk of giving birth to infants with devastating birth defects, including a congenital defect called an omphalocele.

What is an Omphalocele?

An omphalocele is a type of abdominal birth defect in which one or more of an infant’s abdominal organs protrude from the naval. In most cases, these organs are protected only by a thin layer of tissue, and can be easily seen with the naked eye. In minor instances, only the intestines may protrude from the abdomen, while more severe cases involve the spleen and liver as well. This type of malformation occurs when the abdominal muscles fail to close completely during fetal development, allowing the child’s organs to remain outside the umbilical cord.

Omphalocele Treatment and Complications

Approximately 25-40% of children born with an omphalocele suffer from additional birth defects, particularly heart defects, which can cause severe complications for an affected child. Infants born with an omphalocele require surgery in order to repair the defect, although this procedure can be delayed if more serious complications require immediate treatment, such as heart defects. During surgery, a man-made material is stitched in place over the abdomen in order to push the organs back into the abdomen over a period of time. Once the abdominal contents are back in place, the artificial material is removed and the abdomen is closed. In cases in which the omphalocele is too large for this procedure to be performed, the skin around the omphalocele will be permitted to grow around and cover the defect. The skin and abdominal muscles can then be repaired later in life in order to improve the appearance of the abdomen. Unfortunately, even with treatment, some children born with this birth defect will struggle with further complications, including intestinal infection and death of the intestinal tissue.

Prozac Birth Defect Studies and FDA Warnings

The potentially harmful nature of Prozac and other SSRI drugs has been evident for several years. In 2007, the New England Journal of Medicine published two studies in order to evaluate the potentially harmful nature of SSRI antidepressants like Prozac. According to one study, women who took an SSRI like Prozac while pregnant were more than twice as likely to give birth to infants with devastating birth defects like omphalocele, craniosynostosis and anencephaly. The second study indicated that infants born to women who took Prozac or another SSRI during the first trimester of pregnancy were nearly twice as likely to develop birth defects like club foot, anal atresia and limb defects.

Previously, in 2006, the NEJM published a significant study in which researchers found a shocking six-fold increased risk of PPHN among infants whose mothers took an SSRI like Prozac during pregnancy, compared to unexposed infants. PPHN, or persistent pulmonary hypertension of the newborn, is a severe birth defect in which an infant’s circulation continues to bypass the lungs after birth, depriving the rest of the body of oxygen. According to researchers, up to twelve out of 1,000 infants exposed to an SSRI like Prozac developed PPHN, compared to the rate among the general population, which is one to two infants out of 1,000. Shortly after reviewing the results of this study, the FDA issued a public health advisory warning patients and healthcare professionals about the increased risk of PPHN among infants exposed to SSRIs like Prozac in utero. The FDA also required all sponsors of SSRI drugs to change prescribing information to include the potential risk of PPHN.

Prozac Use and Pregnancy

Prozac has been labeled by the FDA as a pregnancy category C medication, which means the drug may cause serious harm to a fetus when taken during pregnancy. The FDA has advised healthcare professionals to avoid prescribing Prozac to pregnant women unless the possible benefits of the treatment outweigh the potential risks to the fetus. If you are currently taking Prozac and you are pregnant or planning to become pregnant, consult your physician to discuss alternative treatment options. You should never stop taking a prescription medication without medical consent, but with your doctor’s help, you may be able to find a safer way to treat your condition.

A Prozac Attorney Can Help

Birth defects like omphaloceles have the potential to cause serious pain and suffering for an affected child, as well as a significant emotional and financial burden for the victim’s family. If you or a loved one has suffered from a birth defect, which you believe to be linked to Prozac, contact a Prozac attorney immediately to discuss your legal options. You may be entitled to financial compensation for your injuries and medical expenses, which you can collect by filing a Prozac lawsuit or Prozac class action lawsuit against Eli Lilly. Defective drug lawsuits also bring public attention to the importance of safe medications and the need for more strict regulations on the dangerous drugs already on the market.

While most consumers understand that no drug is 100% safe, they also expect their prescription medications to treat their condition without causing them any unnecessary harm. Unfortunately, there are some drugs currently on the market for which the possible benefits are actually outweighed by the potential risks associated with the drug. This information may not be known to consumers or even the FDA because some drug companies intentionally withhold dangerous drug information in an attempt to make their product more appealing to the public. This deceptive practice exposes millions of consumers to serious injury and even death, without their knowledge. The only way to protect your rights against dishonest drug companies and to collect the compensation you deserve is to hire a Prozac lawyer to represent your case.

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