The Heart of the Matter
True stories about families coping with antidepressant related birth defects

Child Born with Severe Heart Defects Sues Paxil-Maker

Paxil and other SSRI antidepressants may cause defects in newborn babies

Since September, 2005 information has been emerging 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). Several of these defects have now been linked with other antidepressants such as Celexa, Effexor, Lexapro, Prozac, Symbyax and Zoloft as well.

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).

Baum Hedlund (a pharmaceutical drug product liability law firm that has represented thousands of victims of antidepressants such as Prozac, Zoloft and Paxil)  represents many families whose children were born with heart birth defects or PPHN to mothers who took antidepressants, such as Paxil, during pregnancy. Anyone in need of an antidepressant birth defect lawyer or anyone interested in filing an antidepressant birth defect lawsuit or class action lawsuit should contact Baum Hedlund for a free consultation.

Heart Birth Defects: The FDA issued a Public Health Advisory for Paxil on December 8, 2005 based on U.S. and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations.

PPHN: Persistent pulmonary hypertension (PPHN) is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care.

On July 19, 2006 the FDA issued another Public Health Advisory for Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine, Symbyax (olanzapine and fluoxetine) and Zoloft (sertraline) based on a study that suggests there may be additional risks of SSRI medications during pregnancy. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.

Abdominal Birth Defects: GSK - GlaxoSmithKline, 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 (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.

Cranial Birth Defects: 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
Our firm is also investigating the 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. We are investigating whether or not there is an association between SSRIs and anal atresia.

 

About Baum Hedlund

Since 1990, Baum Hedlund has been handling antidepressant (SSRI-selective serotonin reuptake inhibitors) cases involving personal injury and wrongful death.

Baum Hedlund partner, Karen Barth Menzies, heads the firm's SSRI-Antidepressant Litigation Department and is Lead Counsel for the Plaintiffs' Steering Committee (MDL-1574) Paxil Products Liability Litigation.  She is also leading the team of Baum Hedlund Paxil birth defect attorneys handling the Paxil birth defect cases.

Because of her proactive representation of Paxil suicide victims and their families, (testifying before state legislature and the FDA, meeting with members of the House and Senate, writing articles and giving speeches around the world regarding the risk of antidepressant induced suicide) drug product liability attorney Karen Barth Menzies has received state and national Lawyer of the Year awards and a national 40-top-lawyers-under-40 award for her "extraordinary achievements" and "impressive track record" and for "stepping up her fight in the past few years, advocating that pharmaceutical companies should warn about the alleged risks of antidepressant drugs."

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