Omphalocele Paxil Side Effects

Omphalocele and Paxil side effects have been possibly linked and Paxil attorneys are filing lawsuits on behalf of birth defect affected families.  If your child was born with omphalocele or other Paxil side effects, contact a Paxil lawyer for help.

Paxil side effect studies have identified Paxil use during pregnancy as a possible risk factor for the development of serious side effects, including birth defects like omphalocele in children exposed to the drug in pregnancy. Paxil is currently manufactured by GlaxoSmithKline and has been on the market since the FDA initially approved the drug to treat major depressive disorder in 1992. Since then, Paxil has been additionally approved for the treatment of major panic disorder, obsessive-compulsive disorder, social anxiety disorder, post-traumatic stress disorder and generalized anxiety disorder. Paxil (paroxetine) belong to a class of antidepressant drugs called selective serotonin reuptake inhibitors (SSRIs), and has become one of the most commonly prescribed antidepressant drugs on the U.S. market. Unfortunately, despite the popularity of the antidepressant Paxil, the drug has become the subject of significant scrutiny in recent years, as studies have examined the adverse effects of fetal exposure to Paxil. If you took Paxil while pregnant and your child was born with a birth defect like an omphalocele, contact a Paxil attorney to discuss your legal options. Your child may be entitled to lifetime care, which you can acquire by filing a Paxil lawsuit against GlaxoSmithKline.

Omphalocele Symptoms

An omphalocele is a type of congenital birth defect involving the malformation of a child's abdominal muscles during fetal development. In children born with an omphelocele, the intestines and other abdominal organs protrude from the abdomen, covered only by a thin layer of tissue. An omphalocele occurs when the muscles of the abdominal wall fail to close completely in utero, allowing the abdominal contents to remain outside the umbilical cord. In children with small omphaloceles, only the intestines may be affected, although large omphaloceles may involve the liver and spleen as well.

Omphalocele Treatment and Complications

The main treatment for children with an omphalocele involves surgery to repair the malformation and restore the appearance of the child's abdomen. During surgery, a man-made material is placed over the sac and stitched into place, gradually pushing the abdominal contents back into the abdomen over time. At this point, the artificial material can be removed and the abdomen closed. In instances in which the defect is too large for this procedure to be performed, the skin around the malformation will be left to grow and cover the defect, and the abdominal muscles and skin can be repaired later in life. Most infants who undergo this omphalocele surgery make a full recovery. Unfortunately, some children with an omphalocele may suffer from additional birth defects, and others may struggle with complications like intestinal infection and death of the intestinal tissue.

FDA Warnings and Paxil Side Effect Studies

The FDA has issued two separate public health advisories concerning Paxil, one warning patients and healthcare providers about the possible dangers of Paxil itself, and the other warning about the pregnancy risks of SSRI antidepressants like Paxil. According to the first advisory, women taking Paxil during the first trimester of pregnancy have an increased risk of giving birth to children with major congenital malformations, including heart defects and limb defects. The second warning notified the public about the increased risk of PPHN (persistent pulmonary hypertension of the newborn) in children exposed to SSRI drugs like Paxil during pregnancy. This FDA action was based on the results of a 2006 New England Journal of Medicine study in which researchers found a six-times increased risk of PPHN among infants whose mothers took an SSRI like Paxil after the twentieth week of pregnancy. PPHN is a severe heart and lung side effect in which a child's circulation continues to bypass the lungs after birth, depriving the rest of the body of the oxygen it needs to survive.

The following year, in 2007, the NEJM published two additional studies in which researchers sought to examine the adverse effects of fetal exposure to SSRI antidepressants like Paxil. According to the first study, infants whose mothers took an SSRI during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like club foot, anal atresia and limb defects. Researchers also found a possible link between SSRIs and neural tube birth defects, cleft palate and cleft lip. In the second study, children born to women who took an SSRI like Paxil while pregnant were more than twice as likely to be born with devastating birth defects like omphalocele, anencephaly, and craniosynostosis.

Paxil Use During Pregnancy

The pregnancy category of Paxil has been elevated by the FDA from C to D, which means there is positive human evidence of the drug's potential to cause serious fetal harm when taken during pregnancy. If you are currently taking Paxil and you are pregnant or planning to become pregnant, consult your healthcare provider to discuss alternative treatment options. You should never suddenly stop taking a pharmaceutical drug without medical consent. However, with your doctor's help, you may be able to find a safer way to treat your medical condition.

Paxil Attorneys for Omphalocele Side Effects

Although omphaloceles can be treated with surgery, the possible complications of the birth defect are dangerous and can lead to long-term difficulties. In addition, approximately 25-40% of children with an omphalocele suffer from additional side effects, including birth defects like cardiac malformations. If you or a loved one has suffered from an omphalocele side effect, which you believe to be linked to Paxil, contact a Paxil attorney to discuss the benefits of filing a Paxil lawsuit against GlaxoSmithKline. You are not at fault for any injuries caused by a dangerous pharmaceutical drug. With the help of a qualified Paxil lawyer, you can collect the compensation you deserve and protect yourself and your family from further harm.

Prescription Drugs in The News