Paxil Birth Defects: Heart Defects, PPHN, Omphalocele, Craniosynostosis

Paxil has been linked to serious birth defects including atrial septal heart defects, PPHN, and congenital defects Omphalocele and Craniosynostosis.

Paxil Associated with Persistent Pulmonary Hypertension of the Newborn (PPHN)

Because of recent studies and new information, the “pregnancy use classification” of Paxil has been changed from category C to category D. In December 2005, the FDA required a label revision to warn of the possible adverse effects of Paxil use during pregnancy. Pregnancy Category D means there is positive evidence of human fetal risk based on adverse reaction data from investigation or marketing experience or studies in humans.

FDA Alert: Study Suggests an Increased Risk of Major Congenital Malformations

As a result of the increasing concerns about Paxil, the U.S. Food and Drug Administration issued an FDA alert to health care professionals and patients in September 2005. This letter advised doctors and patients that a study demonstrated taking Paxil® during the first three (3) months of pregnancy increases the risk of birth defects, and in particular heart defects. In fact, women who took Paxil® were twice as likely to give birth to a baby with a heart defect, than other women.

What is Paxil?

Injured infant with congenital heart defect. The medication Paxil® (paroxetine or paroxetine hydrochloride), manufactured by GlaxoSmithKline (“Glaxo”) was developed to treat depression and anxiety. Paroxetine or paroxetine hydrochloride, marketed by the drug name Paxil, was approved as a medication by the U.S. Food and Drug Administration (FDA) in 1992 as a treatment for adult depression, social anxiety disorder, panic disorder, and Premenstrual Dysphoric Disorder. The medication is manufactured and marketed in the U.S. in two versions— Paxil® and also in a controlled release form, Paxil® CR. Paxil is in a class of medications called selective seratonin reuptake inhibitors (SSRIs). SSRIs help maintain a balance of serotonin levels in the brain in order to restore the brain to a normal emotional state.

Paxil Side Effects

While it can be effective for its intended purposes, Paxil can have serious side effects. Since its introduction, the drug has come under increased scrutiny. In 2003, studies revealed that when pregnant women took Paxil, there was a 2.2 fold increase in birth defects, in particular, heart defects. Other risks to a newborn baby can include congenital malformations, hearing loss, and trouble feeding.

Paxil use during pregnancy has been directly linked to an increased risk for birth defects and development of Persistent Pulmonary Hypertension of the Newborn (“PPHN”). This dangerous condition affects the heart and lungs of a newborn. With this condition, the baby’s blood flow bypasses the lungs. As a result, oxygen does not enter the blood stream and therefore, the supply of oxygen to the heart and other organs is cut off. This lack of oxygen may result in organ or tissue damage, heart failure, brain hemorrhage, kidney failure, or possibly death. Even after treatment for PPHN, children may suffer from long-term effects such as pulmonary disorders and breathing problems, developmental delay, seizure disorders and neurological deficits.

Using Paxil during pregnancy has been linked to heart malformations and abdominal and cranial defects. Paxil use during pregnancy has also been linked to other complications, including respiratory distress, hypoglycemia, jaundice, prematurity, and other health problems in the newborn.

Paxil Usage

Statistics show that in 2002 over 25 million prescriptions were written for Paxil. More than 6.3 million Paxil prescriptions were written for women in their childbearing years. In 2003, Glaxo sponsored a study that indicated that use of Paxil during pregnancy increased the risk of Paxil birth defects more than 2-fold, with the most common birth defect being cardiovascular abnormalities. Glaxo continued to market the anti-depressant, Paxil as a Pregnancy Category C drug. This rating indicates that animal studies have shown adverse effects on the fetus but that there are no adequate well-controlled studies in humans. Glaxo waited two years to strengthen their warning on Paxil in December 2005, at the request of the FDA, to name Paxil as a Pregnancy Category D product, meaning there is positive evidence of human fetal risk associated with use during pregnancy.

Pharmaceutical sales are big business and medications for the treatment of anxiety, depression, and obsessive-compulsive disorders are top moneymakers for pharmaceutical giants such as Glaxo who has reported more than $1 billion in annual sales of the drug Paxil (paroxetine).

Since its introduction in 1992, millions of doses of the medication Paxil have been prescribed to treat depression and anxiety. More and more evidence is emerging that using Paxil or other selective serotonin reuptake inhibitors (SSRI) during pregnancy can increase the likelihood of life-threatening birth defects such as heart and lung defects. Mothers who have used Paxil during pregnancy and expectant mothers taking the drug should be aware of these birth defect risks. If your child was born with a birth defect or a congenital heart condition, you should learn as much as you can about your child's condition and what can be done to correct the problem or lessen its effects.

An Ongoing Problem

Glaxo continues to market their product and advise against discontinuing the use of Paxil during pregnancy despite the increased risk for birth defects. To support their position Glaxo cites a study that indicated a 68% relapse rate for major depression during the course of the pregnancy for women who stopped taking medication for depression during pregnancy. As Glaxo points out the risk for recurrence of depression, they fail to indicate that the risk of PPHN doubles with the use of SSRI medications such as Paxil during pregnancy.

The FDA has required label changes and has sent an advisory to doctors informing them of the increased risks for birth defects.

Paxil Risks to Your Child

Using Paxil during pregnancy has been linked to at multiple serious birth defects:

Ventricular and/or Atrial Septal Defects — These defects affect the chambers of the heart and include the medical condition commonly referred to as a “hole in the heart”. These heart defects prevent full oxygenation of the blood by the lungs. In most cases the defect can be corrected by surgery. In a small number of cases it can heal itself as the child grows. Studies indicate that Paxil taken in early pregnancy doubles a baby's chance of being born with a heart defect. During the first several weeks of pregnancy, the baby's heart develops. It is possible that a woman is not even aware she is pregnant before her baby's heart is completely developed.

Persistent Pulmonary Hypertension of the Newborn (PPHN) — Babies born with PPHN have abnormal blood flow through their heart and lungs and do not get enough oxygen to their bodies. Babies born with PPHN can be very sick and may even die. An article in the February 9, 2006 New England Journal of Medicine entitled “Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn” describes a study which found an association between the maternal use of SSRIs (including Paxil) and PPHN in the offspring.

Abdominal Defects – In some instances, babies exposed to Paxil in utero develop abdominal defects such as omphalocele. Omphalocele is a defect in the abdominal wall in which a portion of the baby’s intestines or abdominal organs protrude through the umbilical area and present on the outside of the baby’s body. An omphalocele must be corrected by surgery, but this is often difficult because the child’s abdomen is often smaller than normal and not large enough to hold the abdominal organs, requiring the abdominal cavity to be enlarged in order to accommodate the intestinal contents.

Cranial Defects - Craniosynostosis, also known as cloverleaf skull, is a condition in which the sutures or growth centers between the bones of the infant skull fuse together prematurely. The result is a deformation in the development and shape of the skull which causes problems with normal brain and skull growth, and can lead to an increase in intracranial pressure. For children who experience cranial defects, surgical intervention is required to correct the defect by separating the fused structures and reshaping the skull.

Was your child injured by Paxil?

Protect your child's health and your rights. If you took Paxil or Paxil CR during pregnancy and your child was born with a heart defect or other birth defect, Paxil may be the cause. To ensure that your child's condition is adequately diagnosed and addressed, speak with your doctor. Medical treatment for these conditions is very costly. An attorney at Arnold & Itkin LLP can help explain your legal rights.

Holding GlaxoSmithKline Responsible

GlaxoSmithKline should be held accountable for the suffering your child has and will continue to experience due to injury from Paxil. Manufacturers of prescription drugs have a legal responsibility to develop and market safe products. Unfortunately, drug manufacturers sometimes cut corners or disregard scientific findings and prioritize their company’s profits over consumer safety.

If you or a loved one has suffered serious injuries while using Paxil, or if you used Paxil during pregnancy and your child was born with congenital birth defects, you may be entitled to compensation for your losses and suffering.

Our law firm has the skill, resources, and commitment needed to fight pharmaceutical corporations and obtain favorable results for you. We will form a team of experienced legal professionals and medical and toxicological experts. We will gather evidence, conduct medical tests at our expense, and assess your financial loss and emotional suffering. Arnold & Itkin LLP will work to build a strong and convincing case for your claim. We fight aggressively to maximize the compensation our clients receive. While money alone can never fully compensate you for an injury caused by corporate negligence, it can provide the financial resources you need to face an otherwise uncertain future with greater confidence.

Medical Injury Attorneys for Paxil Injury Claims

Arnold & Itkin LLP is a highly experienced personal injury and pharmaceutical liability law firm. We represent people who have suffered injuries because of defective products and dangerous medications. Such litigation is not easy, but we have a proven track record of success in pharmaceutical litigation and other personal injury cases.

If you took Paxil during pregnancy and your child suffers from a birth defect or other medical condition, call toll-free 1-866-222-2606 or contact us online to speak with one of the medical injury attorneys at Arnold & Itkin LLP so that we may answer your questions and provide additional information that will enable you to make informed choices.

Getting Financial Help

If your child has suffered a birth defect linked to your use of Paxil during pregnancy, you are right to be concerned. Naturally, you want the best for your child, including the medical treatment your child needs to live a life as active and normal as possible.

Congenital defects such as ventricular septal defect or craniosynostosis can be corrected by surgery. The conditions known as persistent pulmonary hypertension of the newborn (PPHN) and omphalocele are potentially life-threatening. Whatever your child's condition, he or she will need care and medical treatment.

As pharmaceutical litigation lawyers serving clients nationwide, Arnold & Itkin LLP seeks to win justice and compensation for you. We may be able to help you win an award that would help compensate you for the financial costs of medical treatment, as well as for emotional suffering from these problems. Our firm seeks to maximize our clients' recoveries.

Strict Time Deadlines for Filing a Claim

In pharmaceutical liability and drug recall matters, there are strict time deadlines for filing a claim. If you miss these deadlines, you will lose your right to claim compensation. If you took Paxil during your pregnancy and your child suffers from a serious health condition, call Arnold & Itkin LLP at 1-866-222-2606 or contact us online to schedule a free consultation and determine the deadline for filing your claim.

Paxil Questions & Answers

I am pregnant now and taking Paxil, what are the potential risks to my child?

Studies show that Paxil use during pregnancy can increase the possibility of birth defects, including atrial and ventricular septal defects in the heart, omphalocele (where the abdominal contents protrude at the umbilical cord), and craniosynostosis which causes the sutures of an infant's skull to close prematurely.

Use of Paxil late in pregnancy has also been linked to Persistent Pulmonary Hypertension of the Newborn (PPHN) which restricts blood flow and is potentially fatal. Your doctor can provide more complete information about the potential risks of using Paxil during pregnancy.

My child has been born with a hole in the heart. What do I do now?

A “hole in the heart”, or ventricular septal defect, affects the chambers of the heart and limits the blood flow to the lungs preventing full oxygenation of the blood. In most cases the defect can be corrected through surgery. Some smaller defects can actually heal themselves as the child grows. The good news is that in most cases, a child born with a hole in the heart can live a normal and active life, provided that he or she receives the right medical treatment. Whatever your child's condition, he or she needs care by an experienced heart specialist.

Where can I find additional information or organizations that provide support for families of children facing these birth defects?

Heart Defects:

Congenital Heart Information Network – Information and support for parents and family members dealing with congenital heart defects.

Kids with Heart – A support group which offers support to families of children with congenital heart defects.

Children’s Heart Foundation – Information and support for dealing with congenital heart defects.

PPHN:

The Wall Center Pulmonary Hypertension Support Group – A resource for patients and family members dealing with Persistent Pulmonary Hypertension of the Newborn.

Omphalocele:

The Fetal Treatment Center – University of California, San Francisco – Omphalocele support group and informational links.

Mothers of Omphaloceles (MOOs) – A source of information and support for families dealing with omphalocele.

Craniosynostosis:

Craniosynostosis and Positional Plagiocephaly Support (CAPPS) – A national non-profit organization that assists families of children with craniosynostosis or positional plagiocephaly.

Cranio Kids – An organization providing support for families seeking information on craniosynostosis founded by a mother and father whose son was born with the condition.

Craniosynostisis Support and Information – A support site started by two mothers whose children were diagnosed and treated for craniosynostosis.

Where can I find reliable legal advice?

In a free consultation, an attorney at Arnold & Itkin LLP can evaluate your case, explain the legal options available to you, and discuss your prospects for obtaining compensation. If we determine that Paxil was the likely cause of your injuries or injuries to your child or loved one, we will fight to obtain compensation and justice for you. Arnold & Itkin LLP will begin work immediately with one aim— to maximize the compensation you receive.

I used Paxil during pregnancy and my child was born with a congenital defect. What can I do?

If you used Paxil or another selective serotonin reuptake inhibitor (SSRI) during your pregnancy, your child's condition may have been caused by your use of the medication. An attorney at Arnold & Itkin LLP can discuss your right to compensation, the strength of your birth defect claim, and what it will take to get results for you. The compensation we obtain can provide the critically needed medical care your child needs in order to live a normal life.

By filing and prevailing in a lawsuit against the manufacturer GlaxoSmith Kline (GSK), you also put them and other pharmaceutical manufacturers on notice that the development and sale of defective drugs will not be allowed. By taking action, you can help improve the safety of new medications and prevent defective pharmaceuticals from coming to market.

For a free consultation with an experienced attorney, contact a medical injury attorney online or phone Arnold & Itkin LLP toll free at 1-866-222-2606.

Paxil® and Paxil CR® are registered trademarks of GlaxoSmithKline.