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Paxil Side Effects / Paxil Birth Defects Lawsuit

What is Paxil?

Paxil is an antidepressant commonly used for the treatment of depression and anxiety. Paxil is a newer type of antidepressant known as an selective serotonin re uptake inhibitor (SSRI). Selective serotonin re uptake inhibitors (SSRI's) are a class of antidepressants. They act within the brain to increase the amount of the neurotransmitter, serotonin (5-hydroxytryptamine or 5-HT), in the synaptic gap by inhibiting its re-uptake. SSRI's are frequently prescribed for anxiety disorders, obsessive-compulsive disorder, and eating disorders. Though not specifically indicated by the manufacturers, they are also sometimes prescribed to treat Irritable Bowel Syndrome.

Paxil Birth Defects

The Food and Drug Administration recently alerted health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.  Paxil is approved for the treatment of depression and several other psychiatric disorders. 

Paxil Birth Defects may include:

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

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

Paxil Birth Defects Lawsuit Information:

For Paxil legal information contact the Paxil Birth Defects Attorneys of Ennis & Ennis, P.A. by filling out our free Paxil case evaluation form or by calling toll-free nationwide: 1-800.856.6405.

Paxil Birth Defects Lawsuit News Archive::

Under no circumstances should you discontinue taking any medication, including Paxil, without first consulting with your doctor.