The popular antidepressant Prozac (generic: fluoxetine) has been used to treat people struggling with depression, anxiety and other mood disorders for over 20 years. Unfortunately, for pregnant mothers, Prozac may put their unborn baby at serious risk of congenital birth defects. Perhaps most seriously, the U.S. Food and Drug Administration linked Prozac to increased risks of persistent pulmonary hypertension (PPHN), a potentially-life threatening condition.

Prozac Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to Prozac, 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.

What birth defects are linked to Prozac and other SSRIs?

The following birth defects have been linked to Prozac and SSRI use:

Prozac Overview

Prozac belongs to a class of drugs known as serotonin reuptake inhibitors (SSRIs), the most common drugs used to treat depression in the United States. Manufactured by Eli Lilly and Company, Prozac was approved in December 1987 as an oral treatment of major depressive-related conditions. Most commonly, Prozac is prescribed to patients who have major depressive disorder, bulimia nervosa, bipolar disorder, obsessive-compulsive disorder, panic disorder and premenstrual dysphoric disorder.

SSRIs work by blocking the re-absorption of serotonin into the brain. Serotonin is a neurotransmitter that regulates mood in the brain. Low levels of serotonin cause mood disorders like depression. By inhibiting re-absorption, SSRIs increase the amount of serotonin in the brain, leading to increased feelings of happiness.

Unfortunately, Prozac and SSRI usage during pregnancy may put an unborn child at serious risk. In recent years, Prozac and SSRIs have been linked to serious defects that occur in babies born to mothers who took the medication during pregnancy. They include withdrawal symptoms, irritability, difficulty in feeding and breathing, heart defects, cranial defects, abdominal formation defects and autism.

The most serious birth defect associated with Prozac use may be persistent pulmonary hypertension (PPHN), a life-threatening disease that causes the blood not to get enough oxygen.

Due to the severity of symptoms associated with Prozac birth defects, you or somebody you know may want to contact one of our Prozac lawyers or attorneys to discuss the possibility of a Prozac birth defects lawsuit.

What is Persistent Pulmonary Hypertension?

The FDA has reviewed the findings of two studies on Prozac (fluoxetine) and issued a Public Health Advisorywarning about birth defect risks. The first study found that women who took SSRIs for depression, then became pregnant, and subsequently discontinued use of the SSRI were 5-times more likely to experience a relapse of depression.

The second FDA-reviewed study found that women who had taken SSRIs after the 20th week of pregnancy experience a 6-fold increase in the risk of PPHN. Normally, it occurs in about 1-2 births per 1,000 in the U.S.

This means that fetuses exposed to Prozac during the third trimester of pregnancy, or the last three months of pregnancy, are at a six-times greater risk of developing persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition where babies have high blood pressure in their lung blood vessels and are not able to get enough oxygen into the bloodstream. PPHN is associated with high risks of disease and death within the first 28 days of life for newborns.

Virtually, PPHN occurs when the breathing patterns in the baby do not switch over from how they occurred in the womb to how they should occur after birth. While the baby is in the uterus, oxygen never touches their lungs. Instead, the placenta supplies the baby with air through the umbilical cord. As a result, the pulmonary artery — which after birth sends blood from the heart to the lungs for oxygen — instead sends blood directly back to the heart through a blood vessel called the ductus arteriosus.

After birth, the ductus arteriosus should permanently close, allowing the pulmonary artery to pump blood from the heart to the lungs to get oxygen. In babies with PPHN, this does not occur, so the blood is not pumped to the lungs to receive oxygen.

The following signs and symptoms may indicate a baby has PPHN:

  • Rapid breathing
  • Rapid heart rate
  • Respiratory distress
  • Cyanosis (bluish-tint to the skin)
  • Heart murmur

Patients should speak with their doctors before discontinuing SSRI use if they become pregnant. As there is the risk of relapse of depression, women should weigh the benefits of SSRI therapy against the risks of PPHN birth defects in their children.

Prozac Heart Defects

A July 2011 Obstetrics and Gynecology study found Prozac (fluoxetine) therapy in pregnant women during the first trimester has been associated with cardiac malformations, including an increased risk of isolated ventricular septal defects, more commonly known as a “holes in the heart.” Meanwhile, another SSRI, Paxil (paroxetine) has been associated with atrial or ventricular septal defects, and right ventricular outflow tract defects.

During ventricular septal defects, the wall between the right and left sides of the heart is not completely developed — there are holes. The two lower chambers of the heart are called ventricles, and the wall connecting them to each other is called the septum. When a hole in the septum occurs, it is known as a septal defect.

A ventricular septal defect is dangerous because it allows oxygenated blood in the left ventricle to mix with unoxygenated blood in the right ventricle. As a result, both ventricles end up working harder because they have to pump a greater volume of blood than normal. Eventually, the left ventricle can work so hard that it begins to fail, which can lead to heart failure.

Symptoms of a ventricular septal defect include:

  • Heart murmur
  • Fast breathing
  • Fainting
  • Shortness of breath
  • Chest pain
  • Sweating
  • Pallor
  • Very fast heartbeats
  • Decreased feeding
  • Pulmonary congestion
  • Poor weight gain
  • Fluid retention
  • Cyanosis

Abdominal and Cranial Birth Defects

The National Birth Defects Prevention Study of Infants found SSRI therapy may cause separate types of defects in a baby’s head and/or in the baby’s abdominal region.
Anencephaly and craniosynostosis are two types of birth defects affecting a baby’s skull or brian. Anencephaly is a condition were portions of the brain or skull are missing. Craniosynostosis a brain condition where parts of the skull close prematurely, which could lead to an abnormally shaped head.

Meanwhile, omphalocele is a birth defect of the abdomen. Omphalocele is a condition where portions of the intestine or other abdominal organs stick out of the baby’s navel or belly button. It occurs because the abdominal wall muscles do not close properly. The organs are covered only by a thin layer of tissue and can easily be seen. It is considered a type of hernia.

Prozac and Autism

Finally, another July 2011 study suggested an increased risk of giving birth to an autistic child after SSRI therapy. The Archives of General Psychiatry found that women who took SSRI antidepressants, especially during the first trimester, were twice as likely to give birth to a child with autism spectrum disorder.

Autism is a complex developmental disability that causes children to have problems communicating and interacting with others.

Signs and symptoms of autism include:

  • Problems communicating verbally
  • Problems communicating non-verbally (unspoken communication which includes eye contact, pointing and smiling)
  • Problems socializing (sharing emotions, understanding how other think or feel)
  • Routines or repetitive behaviors (repeating words or actions, obsessive following routines)

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

Although we encourage all our potential clients to take great care in selecting their Prozac 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 Prozac birth defects lawsuit and look forward to speaking with you.


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