If you or a loved one has taken Paxil® during pregnancy, and your child has suffered a birth defect, contact us here immediately or submit a form here for a free case evaluation here and we will contact you and specifically about Paxil cases involving the following birth defects: ventricular septal defect (“VSD”) (so-called hole in the heart), atrioventricular septal defect (AVSD), any heart defect, omphalocele, craniosynostosis, anencephaly (causing still born birth), “spina bifida” (so-called Neural Tube Defects), Anal Atresia, any limb defects – club foot, ear malformation, etc., and other birth defects.
We will talk to you about your case or let you talk with another Paxil Birth Defect Attorney
What is Paxil?
Paxil®
Paxil® (paroxetine) is one of a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil was first approved in the United States on December 29, 1992, for the treatment of depression. Paroxetine is available as Paxil®, Paxil CR®, Pexeva®, and generic paroxetine hydrochloride. It is manufactured by GlaxoSmithKline.
What Injuries Can Paxil/Other SSRI’s Cause?
Since September, 2005 information has been coming out that Paxil may cause birth defects, including cardiac (heart), pulmonary (lung), neural-tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull), infant omphalocele (abdominal wall defects), club foot (one or both feet turn downward and inward), and anal atresia (complete or partial closure of the anus).
The FDA issued an alert in July 2006 warning about the increased risk of Neonatal Persistent Pulmonary Hypertension (PPHN) by mothers taking SSRI antidepressants such as Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine, Symbyax (olanzapine and fluoxetine) and Zoloft (sertraline).
What is Neonatal Persistent Pulmonary Hypertension (PPHN)?
In the womb, the pathway of your baby’s blood circulation is different than it is after birth. In the uterus, a baby’s circulation bypasses the lungs, and instead the placenta, through the umbilical cord, serves as the organ of gas exchange. The pulmonary artery – which, after birth, will carry blood from the heart to the lungs – in utero sends blood directly back to the fetal heart through a fetal blood vessel called the ductus arteriosus.
When a baby is born and begins to breathe air on their own, the baby’s circulatory system
is shifting from the placenta to the lungs serving as the organ of gas exchange. The pressure in the lungs changes as air enters and inflates the lungs. Because of this, the ductus arteriosus, which previously supplied the fetal heart with blood, closes for good. Blood returning to the heart from the body can now be pumped into the lungs, where oxygen and carbon dioxide are exchanged. The blood is then returned to the heart and pumped back out to the body in an oxygen-rich state.
A dramatic cardiopulmonary transition occurs at birth, characterized by a rapid fall in pulmonary vascular resistance (PVR) and pulmonary artery pressure and a 10-fold rise in pulmonary blood flow. In some newborns, however, the normal decrease in pulmonary vascular tone does not occur, and the result is persistent pulmonary hypertension of the newborn (PPHN).
In a baby with PPHN, the fetal circulatory system doesn’t “switch over.” The ductus arteriosus remains open, and the baby’s blood flow continues to bypass the lungs. Even though the baby is breathing, oxygen in the breathed air will not reach the bloodstream. Because the blood returning from the body is unable to enter the lungs properly – and instead flows through the still-open ductus arteriosus – it returns to the heart in an oxygen-depleted state.
What are atrial and ventricular septal defects (VSDs) of the heart?
A ventricular septal defect (VSDs) is a defect in the ventricular septum, the wall dividing the left and right ventricles of the heart. In other words, VSDs are holes in the walls of the chambers of the heart. A VSD can be detected by cardiac auscultation. Normally, a VSD causes a pathognomonic holo- or pansystolic murmur. VSDs can be diagnosed by non-invasive cardiac echocardiograms.
Atrioventricular septal defect (AVSD) or atrioventricular canal defect (AVCD) is characterized by a deficiency of the atrioventricular septum of the heart.
If there is a defect in the septum, it is possible for blood to travel from the left side of the heart to the right side of the heart, or the other way around. Since the right side of the heart contains venous blood with a low oxygen content, and the left side of the heart contains arterial blood with a high oxygen content, it is beneficial to prevent any communication between the two sides of the heart and prevent the blood from the two sides of the heart from mixing with each other.
AVSDs can be detected by cardiac auscultation as they cause atypical murmurs and loud heart beats. VSDs also can be diagnosed by non-invasive cardiac echocardiograms.
What are the abdominal birth defects associated with Paxil and other SSRIs?
GlaxoSmithKline (“GSK”), maker of Paxil, sent a letter to doctors and healthcare professionals in September, 2005 advising them of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI-antidepressant were more likely than those who were not exposed to have an infant with omphalocele, which is an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel. The strongest effect was reported to be with Paxil, paroxetine, which accounted for 36% of all SSRI exposures.
An omphalocele is a type of abdominal wall defect in which the intestines, liver, and occasionally other organs remain outside of the abdomen in a sac because of a defect in the development of the muscles of the abdominal wall. The omphalocele can be mild, with only a small loop of intestines present outside the abdomen, or severe, containing most of the abdominal organs. In severe cases surgical treatment is made more difficult because the infant’s abdomen is abnormally small because it had no need to expand to accommodate the developing organs. The presence of an omphalocele is often associated with cardiac defects.
What is Craniosynostosis?
Craniosynostosis is a condition in which one or more of the fibrous sutures in an infant skull prematurely fuses. This results in restricted skull and brain growth. Because the brain cannot expand in the direction of the fused suture, it is forced to grow in the direction of the open sutures, often resulting in an abnormal head shape and facial features.
In an infant, the skull is not one solid bone, it is bony plates separated by fibrous sutures. The infant’s skull consists of the metopic suture, coronal sutures, sagittal suture, and lambdoid sutures. These sutures allow the skull to expand as an infant’s brain develops. Over time these sutures eventually fuse into the solid skull.
Surgery is typically used to separate the fused sutures of the skull as well as to reshape the skull. To treat the cosmetic troubles, a combination of orthodontic and orthognathic surgery can be used to relieve some of the midface deficiency.
GSK – GlaxoSmithKline included in the September, 2005 “Dear Doctor” letter that the authors of the above study also found an association of exposure to any SSRI-antidepressant and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)
Other Birth Defects
There is ongoing investigation by attorneys into a possible link between Paxil and birth defects such as:
Club Foot: A recent study conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany and a recent study from the Slone Epidemiology Center at Boston University found that some women who took SSRIs throughout their pregnancy had children born with club feet. True Club foot is a malformation. The bones, joints, muscles, and blood vessels of the limb are abnormal. An infant with club foot has a foot that is inturned, stiff and cannot be brought to a normal position.
Neural Tube Defects: Neural tube defects (or NTDs) are birth defects of the brain and spinal cord. The two most common neural tube defects are spina bifida and anencephaly. In spina bifida, the fetal spinal column doesn’t close completely during the first month of pregnancy. There is usually nerve damage that causes at least some paralysis of the legs. In anencephaly, much of the brain does not develop. Babies with anencephaly are either stillborn or die shortly after birth. Source: National Institute of Child Health and Human Development
Anal Atresia: Also called Imperforate anus, anal atresia is a congenital malformation in which the normal perforation we call the anus, is absent. The end of the intestinal tract has not perforated the skin in the perineal area. Atresia is the absence of a normal opening or failure of a structure to be tubular.
Links:
FDA Advising of Risk of Birth Defects with Paxil: Agency Requiring Updated Product Labeling (FDA news release, September 8, 2005):
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108527.htm
information concerning today’s announcement is available on FDA’s Web site at:
Public Health Advisory: http://www.fda.gov/cder/drug/advisory/paroxetine200512.htm and
Click this link for Paxil Information from FDA:
http://www.fda.gov/cder/drug/infopage/paroxetine/default.htm
News links:
National Briefing | Science And Health: Warning On Paxil (Nytimes 1/1/2006):
http://query.nytimes.com/gst/fullpage.html?res=9C03E1DA1E3EF932A35751C1A9609C8B63
Web MD: New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants:
http://www.webmd.com/baby/news/20050927/paxils-birth-defects-warning-strengthened
Glaxo E-Mails Over Paxil Study Must Be Turned Over: http://www.bloomberg.com/apps/news?pid=20601085&sid=aOcgK5LorDgU