Mounting research and numerous case studies have found that expecting mothers who take GSK’s popular antidepressant Paxil during pregnancy are more than twice as likely to give birth to babies with congenital defects than women who took no such medications during pregnancy. These potentially life-threatening Paxil birth defects include congenital heart defects, persistent pulmonary hypertension of the newborn (PPHN), and cranial defects such as craniosynostosis. As a result, some women are investigating filing their own Paxil lawsuits, alleging that GSK did not properly warn them about the risks associated with taking Paxil during pregnancy.

Paxil Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to Paxil, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 588-0600.

Which birth defects have been linked to Paxil?

The U.S. Food & Drug Administration (FDA) has alerted healthcare professionals and patients about studies suggesting that Paxil increases the risk for a variety of extremely serious birth defects. The following is a list of birth defects that are currently being evaluated for potential Paxil lawsuits:

Paxil Heart Defects

The majority of the cardiac defect reports received by the FDA concerning Paxil have involved atrial or septal heart defects, conditions in which the wall between the right and left sides of the heart are not completely developed. In general, septal heart defects are among the most commonly reported congenital abnormalities associated with maternal Paxil use in pregnancy.

Children who have major Paxil-induced heart defects usually need surgery to close the hole in their heart. If your baby has a heart defect that requires surgical repair, the procedure will likely be scheduled in the baby’s first year of life. Surgical treatment involves plugging or patching the opening between the ventricles. To learn more about septal heart defects, please visit the Mayo Clinic Website for more information.

Paxil & Persistent Pulmonary Hypertension of the Newborn (PPHN)

A study published in the New England Journal of Medicine (NEJM) found that children of women taking antidepressants like Paxil while pregnant were at an increased risk of developing persistent pulmonary hypertension of the newborn (PPHN). Babies born with PPHN suffer from circulatory problems that can lead to respiratory failure shortly after birth. Signs and symptoms of Paxil-induced persistent pulmonary hypertension of the newborn may include:

  • rapid heart rate
  • rapid and difficulty breathing
  • signs of respiratory distress (i.e nostril flaring and grunting)
  • bluish skin tone (cyanosis)
  • oxygen deprivation

Sadly, 10 to 20 percent of infants born with PPHN do not survive despite treatment.

Paxil Overview

Manufactured and marketed by GlaxoSmithKline (GSK), Paxil is an FDA-approved antidepressant commonly used in the treatment of anxiety and depression. Paxil belongs to a class of controversial medications known as selective serotonin reuptake inhibitors (SSRIs). SSRIs are designed to work within the brain to increase the amount of the neurotransmitter serotonin in the synaptic gap by initiating its reabsorption (reuptake). Paxil is frequently prescribed for anxiety disorders, obsessive-compulsive disorder (OCD), as well as a variety of eating disorders.Though not specifically indicated by the manufacturer, Paxil is also sometimes prescribed in an off-label capacity (for which it has been neither tested nor approved by the FDA) for the treatment of irritable bowel syndrome.

Paxil is used by millions of people worldwide, with sales reaching $1 billion annually. In response to the recent findings linking the drug to birth defects, medical professionals are currently taking a hard look at the risks and benefits of prescribing Paxil to their patients. Many organizations are recommending that women who are pregnant or may become pregnant to avoid taking Paxil due to the potential risk of their baby being born with a congenital defect. Experts estimate that there are hundreds of infants born with Paxil-related birth defects and, even with the proper treatment, 20% of the babies will not survive.

Paxil FDA Warning

In December 2005, the FDA issued a press release warning pregnant women and their doctors of an increased risk of heart defects in babies born to mothers who took Paxil in pregnancy (especially during the first trimester, a time when many women may still be unaware that they are pregnant). The administration reviewed two independently conducted studies that found that expecting mothers who took Paxil during their first trimester of pregnancy were nearly twice as likely to give birth to a child with a congenital heart condition than mothers from control groups who took no such antidepressants.

In addition to the warning, the FDA reclassified Paxil into Pregnancy Category D, which means the drug may cause heart defects or serious lung problems in newborns if the medication is taken during pregnancy. Pregnancy Category D drugs have shown positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. The FDA warned that ‘this drug should usually not be taken during pregnancy… and should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.’

Baby born with Paxil Birth Defects? Contact us today.

If you or someone you love took Paxil during pregnancy and gave birth to a child with any of the congenital defects listed in this article, our Paxil lawyers may be able to help. Please fill out the confidential contact form below or call (866) 588-0600 to speak with an attorney who will evaluate your Paxil birth defect claim for free.

Is there a time limit in filing a Paxil birth defects lawsuit?

Although we encourage all our potential clients to take great care in selecting their Paxil lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 588-0600.

We hope we will be able to assist you with your potential Paxil birth defects lawsuit and look forward to speaking with you.


Attention Lawyers:  Schmidt & Clark, LLP considers a referral from another lawyer to be one of the greatest compliments. Our law firm has built a reputation for success and accepts a number of case referrals on a regular basis. We do not publish prior verdicts or settlements on our website. If you would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please fill out the form below.