Paxil Birth Defect Lawsuit
Paxil has been linked to serious birth defects including atrial septal heart defects, PPHN, and congenital defects. Paxil (paroxetine or paroxetine hydrochloride), manufactured by GlaxoSmithKline was developed to treat depression and anxiety. It was approved as a medication by the U.S. Food and Drug Administration (FDA) in 1992 as a treatment for adult depression, social anxiety disorder, panic disorder, and Premenstrual Dysphoric Disorder. The medication is manufactured and marketed in the U.S. in two versions: Paxil and also in a controlled release form, Paxil CR. Paxil is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). SSRIs help maintain a balance of serotonin levels in the brain in order to restore the brain to a normal emotional state.
Studies That Confirm Paxil Birth Injuries
In 2005, two separate studies conducted by American and Swedish researchers revealed an increased risk of heart defects in babies born to pregnant women who took Paxil during the first 3 months of pregnancy. The American findings showed a 1.5% higher risk of heart related birth defects in women who took the drug versus those who did not. The Swedish studies placed the risk of heart related birth defects at 2% higher. In 2006, the New England Journal of Medicine published its studies which found a high risk of a condition called persistent pulmonary hypertension of the newborn (PPHN). Per the study, women who took Paxil at or after the 20th week of pregnancy were likely to have babies that were at least 6 times more at risk for PPHN, than babies whose mothers were not on an antidepressant.
Paxil Usage: An Ongoing Problem
Statistics show that in 2002 over 25 million prescriptions were written for Paxil. More than 6.3 million Paxil prescriptions were written for women in their childbearing years. In 2003, Glaxo sponsored a study that indicated that use of Paxil during pregnancy increased the risk of birth defects more than 2-fold, with the most common birth defect being cardiovascular abnormalities. Glaxo continued to market Paxil as a Pregnancy Category C drug. This rating indicates that animal studies have shown adverse effects on the fetus but that there are no adequate well-controlled studies in humans. Glaxo waited two years to strengthen their warning on Paxil in December 2005, at the request of the FDA, to name Paxil as a Pregnancy Category D product, meaning there is positive evidence of human fetal risk associated with use during pregnancy.
Glaxo continues to market their product and advise against discontinuing the use of Paxil during pregnancy despite the increased risk for birth defects. To support their position, Glaxo cites a study that indicated a 68% relapse rate for major depression during the course of the pregnancy for women who stopped taking medication for depression during pregnancy. As Glaxo points out the risk for recurrence of depression, they fail to indicate that the risk of PPHN doubles with the use of SSRI medications such as Paxil during pregnancy. The FDA has required label changes and has sent an advisory to doctors informing them of the increased risks for birth defects. If your child has suffered from these side effects, then do not wait to contact a Houston personal injury lawyer as soon as possible.
Using Paxil during pregnancy has been linked to multiple serious birth defects:
Ventricular and/or Atrial Septal Defects:
These defects affect the chambers of the heart and prevent full oxygenation of the blood by the lungs. In most cases the defect can be corrected by surgery. In a small number of cases it can heal itself as the child grows. Studies indicate that Paxil taken in early pregnancy doubles a baby’s chance of being born with a heart defect. During the first several weeks of pregnancy, the baby’s heart develops. It is possible that a woman is not even aware she is pregnant before her baby’s heart is completely developed.
Persistent Pulmonary Hypertension of the Newborn (PPHN):
Babies born with PPHN have abnormal blood flow through their heart and lungs and do not get enough oxygen to their bodies. An article in the February 2006 edition of the New England Journal of Medicine describes a study that found an association between the maternal use of SSRIs (including Paxil) and PPHN in the offspring.
In some instances, babies exposed to Paxil in utero develop abdominal defects such as omphalocele. Omphalocele is a defect in the abdominal wall in which a portion of the baby’s intestines or abdominal organs protrude through the umbilical area and present on the outside of the baby’s body. An omphalocele must be corrected by surgery, but this is often difficult because the child’s abdomen is often smaller than normal and not large enough to hold the abdominal organs, requiring the abdominal cavity to be enlarged.
Craniosynostosis, also known as cloverleaf skull, is a condition in which the sutures or growth centers between the bones of the infant skull fuse together prematurely. The result is a deformation in the development and shape of the skull which causes problems with normal brain and skull growth, and can lead to an increase in intracranial pressure. For children who experience cranial defects, surgical intervention is required to correct the defect by separating the fused structures and reshaping the skull.
Was Your Child Injured By Paxil? Contact a Skilled Lawyer Today!
Pharmaceutical sales are big business and medications for the treatment of anxiety, depression, and OCD are top moneymakers for pharmaceutical giants such as Glaxo who has reported more than $1 billion in annual sales of Paxil. Since its introduction in 1992, millions of doses of Paxil have been prescribed to treat depression and anxiety. However, more and more evidence is emerging that using Paxil or other SSRIs during pregnancy can increase the likelihood of life-threatening birth defects such as heart and lung defects. Mothers who have used Paxil during pregnancy and expectant mothers taking the drug should be aware of these birth defect risks.
If your child was born with a birth defect, you should learn as much as you can about your child’s condition and what can be done to correct the problem or lessen its effects. To ensure that your child’s condition is adequately diagnosed and addressed, speak with your doctor. In addition, do not hesitate to speak to an attorney at Arnold & Itkin LLP. Our law firm has the skill, resources, and commitment needed to fight pharmaceutical corporations and obtain favorable results for you. While money alone can never fully compensate you for an injury caused by corporate negligence, it can provide the financial resources you need to face an uncertain future with greater confidence. Request your free case evaluation with our team to get started.