Omphalocele - Consumer Justice Foundation


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Celexa and Omphalocele

One of the many prescription antidepressant medications currently on the market is an SSRI drug called Celexa, manufactured by pharmaceutical company Forest Laboratories. SSRIs, or selective serotonin reuptake inhibitors, were originally developed as a first line of defense against depression, and have since been prescribed for a number of other approved and off-label purposes as well. Celexa, for example, was approved by the FDA in 1998 for the treatment of major depressive disorder, and is also commonly prescribed for off-label uses, such as the treatment of obsessive-compulsive disorder, anxiety, panic disorder, and certain eating disorders. The active ingredient in Celexa is citalopram, and the drug functions by restoring balance to the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Although Celexa has become one of the most commonly prescribed antidepressant drugs available, recent research may result in the re-evaluation of the safety of this medication. According to a number of studies, women who take SSRIs like Celexa during pregnancy may significantly increase their chances of giving birth to infants with major birth defects, including omphaloceles.

Omphalocele Signs and Symptoms

An omphalocele is a congenital birth defect characterized by the protrusion of a child’s abdominal contents through the naval. This defect is a type of hernia in which the muscles of the abdominal wall fail to close completely during fetal development, allowing abdominal organs to remain outside the umbilical cord. These organs are typically covered only by a thin layer of tissue and can easily be seen with the naked eye. If the omphalocele is small, only the infant’s intestines may be exposed, whereas larger defects may involve the liver and spleen as well.

Omphalocele Birth Defect Treatment

Omphaloceles are typically repaired with surgery, although the procedure can be delayed if more serious defects are present which require immediate treatment. Omphalocele treatment involves a man-made material being stitched over the defect, which pushes the abdominal contents back into place over time. When this process is complete, the artificial material is removed and the abdomen is closed.

Omphalocele Birth Injury Complications

In some cases, an omphalocele may be too large to fit inside the abdomen, in which case the skin around the defect will be permitted to grow and eventually cover the omphalocele. The skin and abdominal muscles can then be repaired later in life in order to restore the abdomen’s normal appearance. Although most infants with this defect make a full recovery after surgery, it is estimated that 25-40% of infants with an omphalocele are born with additional birth defects, particularly heart defects, which can be life-threatening. Some affected infants may also suffer from intestinal infection and death of the intestinal tissue as a result of the malformation.

Celexa and SSRI Birth Defect Studies

In 2006, the New England Journal of Medicine published a study in which researchers found a potential connection between SSRI use during pregnancy and PPHN. PPHN, or persistent pulmonary hypertension of the newborn, is a serious heart and lung condition in which a child’s circulation continues to bypass the lungs after birth. According to the NEJM report, infants born to women who took an SSRI like Celexa after the twentieth week of pregnancy were six times more likely to be born with PPHN, compared to infants who were not exposed to an SSRI in utero. Two other SSRI birth defect studies were published recently in the American Journal of Nursing and the journal Pediatrics. The former study found that women who took SSRIs while pregnant were nearly twice as likely to give birth to infants with septal heart defects than unexposed infants (0.9% prevalence compared to 0.5%). The latter study determined that infants who were exposed to SSRI antidepressants like Celexa in utero had an increased risk of suffering from issues like abnormal heart rhythms, unusual sleeping patterns, problems with alertness, and disrupted neurological development.

Celexa Use During Pregnancy and FDA Warnings

Celexa has been classified by the FDA as a pregnancy category C medication, a category reserved for drugs with the potential to cause serious harm to an infant when taken during pregnancy. In response to the 2006 NEJM study, the FDA issued a public health advisory warning patients and healthcare providers about the potential connection between the use of SSRIs like Celexa during pregnancy and the development of PPHN among exposed infants. The FDA also required all sponsors of SSRIs to update their drug warning labels to include potential pregnancy precautions, namely PPHN.

If you are currently taking Celexa and you are pregnant or planning to become pregnant, consult your physician immediately. You should never stop taking a prescription medication without medical consent, as this may cause further harm. However, with your doctor’s help, you may be able to find a safer alternative to Celexa for treating your medical condition.

Contact a Celexa Attorney for Help

Birth defects like omphaloceles have the potential to cause significant pain and suffering for an affected child, as well as an overwhelming financial burden for the victim’s family, which may incur the cost of medical treatment. If you or a loved one has suffered from an omphalocele which you believe to be associated with the use of Celexa, contact a Celexa attorney as soon as possible. You may have grounds to file a Celexa lawsuit against Forest Laboratories, in order to seek financial compensation for your injuries, the medical expenses resulting from injury treatment, and the pain and suffering endured by you and your family. Defective drug lawsuits also bring much-needed attention to the importance of safe medications and the need for more strict regulations on the dangerous drugs already on the market.

Pharmaceutical companies are responsible for the safety of their medications even after they enter the market, and should be held liable for any adverse side effects sustained by consumers of their products. Unfortunately, some drug manufacturing companies choose to operate in their own best interest, intentionally withholding dangerous drug information in order to prevent negative consequences, subsequently disregarding the safety and well-being of the public. This leaves consumers vulnerable to serious injury and even death simply by taking their prescription medications. Only by hiring a qualified Celexa lawyer to represent their case can victims of alleged Celexa birth defects protect their rights and collect the compensation they deserve.

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