Paxil - Omphalocele - Consumer Justice Foundation

Paxil – Omphalocele

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Paxil and Omphalocele Birth Defects

Paxil is one of a group of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. These drugs work by restoring the balance of serotonin in the brain, a neurotransmitter responsible for affecting mood. By doing so, these drugs can effectively relieve depression and improve certain mood disorders. Paxil was approved by the FDA in 1992 for the treatment of major depressive disorder, in 1996 for major panic disorder and obsessive-compulsive disorder, in 1999 for social anxiety disorder, in 2000 for post-traumatic stress disorder, and in 2001 for generalized anxiety disorder. Paxil (paroxetine) is currently manufactured by pharmaceutical company GlaxoSmithKline.

SSRI antidepressant medications like Paxil have quickly become one of the most commonly prescribed classes of prescription medications on the U.S. market. Unfortunately, recent research has suggested that these drugs may be dangerous in treating certain individuals, particularly pregnant women. According to a number of medical studies, women who take SSRI antidepressants like Paxil while pregnant may significantly increase their risk of giving birth to infants with major birth defects like omphaloceles.

Omphalocele Signs and Symptoms

An omphalocele is a congenital birth defect caused by the failure of the abdominal wall muscles to form properly in utero, allowing one or more abdominal organs to remain outside the umbilical cord. The severity of an omphalocele is determined by its size. In cases of a small defect, only the intestines may protrude from the naval, whereas if the defect is large, the spleen and liver may be involved as well. The affected organs are typically only protected by a thin layer of tissue and can easily be seen with the naked eye.

Omphalocele Birth Injury Treatment and Prognosis

Omphaloceles are typically repaired with surgery; during this procedure, a man-made material is placed over the abdomen and stitched in place. Over time, the abdominal contents will be pushed back into the abdomen, after which the artificial material can be removed and the abdomen closed. If the defect is too large for this procedure to be performed, the omphalocele will typically be left untreated for a certain amount of time, during which 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 restore the abdomen’s normal appearance. Unfortunately, even with successful surgery, infants with this condition may struggle with complications like intestinal infection and death of the intestinal tissue.

Alleged Paxil Birth Defects and FDA Warnings

In 2005, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of congenital birth defects, particular heart defects, among infants exposed to paroxetine (Paxil) during pregnancy. The FDA warning also increased the pregnancy category of Paxil from C to D. This public health advisory was directly influenced by information provided by two unpublished epidemiology studies, both of which suggested that in-utero paroxetine exposure may have harmful effects on exposed infants. The first study gathered data from a Swedish national pregnancy registry and determined that infants born to women who took Paxil during early pregnancy were nearly twice as likely to develop a heart defect, compared to the entire registry population. The second study took place in the United States and indicated that infants whose mothers took Paxil during the first trimester of pregnancy had a 1.5-fold increased risk of heart defects and a 1.8-fold increased risk of congenital birth defects in general, compared to infants exposed to other antidepressant drugs in utero.

In 2006, the FDA issued another public health advisory warning patients and physicians about the increased risk of PPHN among infants exposed to SSRI antidepressants like Paxil during pregnancy. This notice came on the heels of a New England Journal of Medicine study published earlier that year in which researchers determined that infants exposed to SSRIs like Paxil after the twentieth week of pregnancy were six times more likely to develop PPHN, compared to unexposed infants. PPHN, or persistent pulmonary hypertension of the newborn, is a severe heart and lung condition in which a child’s circulation continues to bypass the lungs after birth, depriving the body’s vital organs and tissues of oxygen. In 2007, the NEJM published two additional studies in which researchers sought to examine the adverse effects of SSRI antidepressants on exposed infants. The first study indicated that infants whose mothers took Paxil during the first trimester of pregnancy were nearly twice as likely to be born with birth defects like limb defects, anal atresia 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 SSRIs like Paxil in utero were more than twice as likely to develop devastating birth defects like omphalocele, craniosynostosis and anencephaly.

Paxil Use While Pregnant

The FDA has elevated the pregnancy category of Paxil from C to D, which means the FDA has reviewed positive human evidence illustrating the drug’s potential to cause serious harm to a fetus when taken during pregnancy. The FDA has also advised physicians to avoid prescribing Paxil to pregnant women unless the possible benefits of the treatment justify the potential risks to the fetus. If you are currently taking Paxil and you are pregnant or planning to become pregnant, consult your physician immediately. 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.

Contact a Paxil Attorney for Help

Seeking proper care for infants with an omphalocele is likely to result in costly medical expenses for the child’s family. In addition, it is estimated that 25-40% of infants born with an omphalocele suffer from additional birth defects, typically heart defects, which can cause further complications for an affected child. If you or a loved one has suffered from an omphalocele and you believe Paxil to be the cause, contact a Paxil attorney to discuss your legal options. You may be entitled to reimbursement for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Paxil lawsuit against GlaxoSmithKline. By filing a defective drug lawsuit, victims of defective drug injuries can also bring public attention to the importance of safe medications and the need for more strict regulations on the dangerous drugs currently on the market.

While most consumers understand that no drug is 100% safe, they do expect to be immediately and adequately notified of any hazards associated with their prescription medications. Only by being aware of all benefits and risks involved can consumers make an educated decision to continue or discontinue use of a medication. Unfortunately, some drug companies intentionally conceal dangerous drug information in an attempt to avoid negative consequences, such as a drug recall. This deceptive practice puts millions of consumers unknowingly at risk of suffering serious injury, illness, and even death, which could have been avoided had the drug company taken the appropriate steps to prevent unnecessary harm. With the help of a qualified Paxil lawyer, victims of alleged Paxil birth defects can feel confident that their case is in good hands.

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