Posted In: Drug Litigation

Paxil® Birth Defect Related Lawsuits

Recent studies have shown that Selective Serotonin Reuptake Inhibitors (SSRI) are directly linked to birth defects. These defects include, but are not limited to Persistent Pulmonary Hypertension (PPHN), heart, lung, abdominal and cranial defects.

Paxil®, which is marketed by GlaxoSmithKline, is an antidepressant that is generally prescribed to treat major depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD).

Common Birth Defects

The U.S. Food & Drug Administration has warned patients that taking Paxil® or any other SSRI during pregnancy has been directly linked to Congenital Heart Defects. These birth defects were 5 times more likely to occur in women who have taken it during pregnancy. The most common defects are Heart Defects, Persistent Pulmonary Hypertension and Abdominal & Cranial birth defects. The heart defects were, in most cases, Atrial and Ventricular Septal Defects, which are characterized by holes in the walls of the chambers of the heart. Heart-related birth defects range in severity from minor, which may resolve without treatment, to severe conditions, which usually require surgical repair. Other birth defects include:


Certain antidepressants, including Paxil, have been linked to an increased risk of autism. A report published in the Archives of General Psychiatry reveals new research that links the use of SSRI (selective serotonin reuptake inhibitors) antidepressants during pregnancy with autism spectrum disorders (ASDs) in children.

In recent studies, researchers found a significantly higher risk of autism spectrum disorders associated with treatment with SSRI antidepressants by the mother during the year before delivery, with the strongest effect associated with treatment during the first trimester. The medical records came from the Childhood Autism Perinatal Study, which was conducted by Kaiser Permanente Medical Care in Northern California.

“Use of antidepressant medications during pregnancy also shows a secular increase in recent decades, prompting concerns that prenatal exposure may contribute to increased risk of ASD,” researchers concluded, adding that further studies will be needed to replicate and extend their findings.

Spina Bifida: Recent studies have shown that taking Paxil causes an increased risk for spina bifida.

PPHN: Persistent pulmonary hypertension (PPHN) is a serious and life-threatening lung condition that occurs soon after the birth of the newborn.

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 September 2005 the “Dear Doctor” letter that the authors of the above study also found an association of exposure to any SSRI-antidepressant with giving birth to an infant with craniosynostosis (a congenital defect). Craniosynostosis occurs when the bones prematurely close during the first year of life, which causes an abnormally shaped skull.

Clubfoot: Recent studies conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany and the Slone Epidemiology Center at Boston University found that some women who took SSRIs throughout their pregnancy had children born with clubfoot. True clubfoot is a malformation where the bones, joints, muscles and/or blood vessels of the limb are abnormal. An infant with clubfeet 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.

Drug companies have often downplayed the risk to fetuses of the use of these drugs during the first trimester of pregnancy. However, recent studies have shown a significant increase in the occurrence of serious birth defects as a result of using some of these drugs during the first trimester. If you were taking an SSRI before you found out you were pregnant, there is a possibility that your child’s birth defect was caused by the drug — even if you stopped taking it once you found out you were pregnant! Recent litigation has held these drug companies accountable for their failure to warn of these risks. If you or a loved one has taken an SSRI and given birth to a child with a congenital birth defect, you may be entitled to compensation.

Do I have a Paxil® birth defect-related Lawsuit?

Slater Slater Schulman LLP is dedicated to the representation of plaintiffs in Paxil® lawsuits. Our firm is handling litigation related to these injuries nationwide.

If you or someone you love has taken Paxil® while pregnant and given birth to a child with a congenital birth defect, you should contact Slater Slater Schulman LLP for a free consultation by filling out the form on this page or by calling us at (800) 251-6990.

Medical Disclaimer: Please note that any change in medications should be made only after consulting with your doctor about the risks and benefits of doing so, and should not be based on any information contained in this web site or on a commercial.

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