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Paxil Birth Defects, PPHN and Infant Death

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On September 27, 2005, the FDA issued an alert to healthcare professionals and consumers as GlaxoSmithKline changed their warning label on Paxil (paroxetine) to include the risk of birth defects. These Paxil side effects include Paxil PPHN (Persistant Pulmonary Hypertension in the Newborn). The results of a recent study conducted by the two indicated an increased risk of babies born with Paxil birth defects, specifically cardiovascular defects or congenital malformations, in instances where the mother was taking Paxil during the first trimester of pregnancy.


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Paxil Birth Defects

Paxil alleged to cause birth defects Paxil, as well as other SSRIs, has been linked to Persistant Pulmonary Hypertension in the Newborn (PPHN) - a devastating condition affecting the heart and lungs of newborn infants. Babies are unable to breath properly due to constricted blood vessels which cut off oxygen to the blood and cause damage to other organs such as brain and kidneys.

Even babies that receive treatment for Paxil PPHN may not recover, and those that do may have long-term breathing problems.

Paxil is used by millions of people worldwide and generates more than $1 billion in annual sales. Paxil has been in the news previously for complaints of severe withdrawal symptoms and risks of Paxil suicidal behavior and increased violence in children and adolescents. Paxil is known as a Selective Serotonin Reuptake Inhibitor (SSRI).

The FDA warns physicians to carefully weigh the potential risks and benefits of prescribing or renewing Paxil prescriptions to women during pregnancy or while breast-feeding. It is important that all patients are aware of the side effects, risks, and treatment alternatives.

In December 2011, the FDA announced that there is no clear link between PPHN and the use of SSRIs while pregnant. Although two studies suggested a link between the use of SSRIs while pregnant and the development of PPHN, three studies did not support that finding. The FDA is now advising women who are taking antidepressants while pregnant not to stop.

Paxil Prenatal Exposure Risks

Paxil has the potential to influence fetal development, resulting in congenital defects in newborns, and withdrawal symptoms that torment babies for days or weeks after birth.

A study published in the July 2011 issue of Obstetrics & Gynecology suggests that Paxil use during pregnancy is associated with an increased risk of right ventricular outflow tract defects. Although the increased risk is small, researchers warn that physicians should consider other options when prescribing SSRIs to women who are planning on becoming pregnant.

Meanwhile, a study published in the Archives of General Psychiatry (07/11) suggests that use of SSRIs during pregnancy is linked to an increased risk of having a baby born with autism spectrum disorder. Researchers found that the risk doubled when SSRIs were taken during the 12 months prior to delivery and quadrupled when SSRIs were taken during the first trimester.

What is Paroxetine

Paxil (paroxetine) is a class of medicines called selective serotonin reuptake inhibitors (SSRIs). It is used to treat:
  • Depression

  • Panic disorder

  • Social anxiety disorder (SAD)

  • Obsessive-coompulsive disorder (OCD)

  • Posttraumatic stress disorder (PTSD)

  • Generalized anxiety disorder (GAD)

Paxil / Paxil Birth Defect Legal Help

If you took Paxil during pregnancy, and your baby was born with persistant pulmonary hypertension in the newborn (PPHN), please contact a lawyer by clicking on the link below. Your claim will be evaluated at no cost.
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Weighing the Pros and Cons of Paxil
Weighing the Pros and Cons of Paxil
April 20, 2012
Miami, FL It is well known that certain chemicals affect a fetus, which is why pregnant women are discouraged from smoking or drinking. What is less certain, however, is what effect antidepressant use during pregnancy has on the fetus and what the risk of Paxil birth defects or Paxil side effects in the infant is. Paxil lawsuits were filed, and many have reportedly been settled, but the science—and the US Food and Drug Administration's stance on the issue—is more complicated [READ MORE]

More Possible Paxil Side Effects Come to Light
More Possible Paxil Side Effects Come to Light
March 30, 2012
Dallas, TX For women with depression who are also pregnant, there may be no easy answer to the question of whether or not to risk Paxil side effects by taking the antidepressant while pregnant. Although some studies indicate a risk of Paxil birth defects, including Paxil PPHN (persistent pulmonary hypertension of the newborn), there is also a risk of having untreated depression while pregnant, and the US Food and Drug Administration (FDA) recently revised its stance on antidepressant use during pregnancy [READ MORE]

Paxil Side Effects the Ultimate Catch 22
Paxil Side Effects the Ultimate Catch 22
January 28, 2012
New York, NY Paxil appears to be among those drugs that might qualify under "damned-if-you-do, damned-if-you-don't" status. Paxil side effects are many and varied, serving as a trigger for many a Paxil lawsuit. And yet, in spite of continued warnings by the US Food and Drug Administration (FDA) that link the antidepressant to such adverse reactions as birth defects, proponents continue to sing its praises and the debate continues [READ MORE]


Posted by
My daughter is high-functioning, but she has special needs that put strains (emotional & financial) on the family.

Posted by
Both our daughters were born premature with breathing problems. Kathleen was born one year earlier and was also 6 weeks early, and spent time in the NICU. These stays were very difficult on my husband and me. We were new parents, and scared for our childrens' health and well being!!

Posted by
Both of my sons have Asperger's syndrome (high functioning autism). One had chronic reflux, and has sensory integration disorder. The other has had strokes, also has sensory integration disorder and a host of other medical problems with severe developmental delays. I have found several web sites with people relating the use of Paxil and having children with autism.

Posted by
My daughter was born with vegetation tumors in the right atrial of her heart, which were surgerically removed at the age of 3 months. Since then, my child suffers from autism and severe breathing problems. She is in special classes at school because she cannot function in a normal classroom. She is disabled. I am not able to work because I must care for her.

Posted by
I was taking Paxil back in 2000-2001 when I was pregnant. My son who is now 6 always cried uncontrollably when he was born and spent the 2nd day of his life in hospital for constant vomiting. He has always been super hyper!! Constantly worrying if the paxil affected my son.

Posted by
During my sons 5 years he has seen more emergency rooms, racked up more hospital stays, and had more surgeries than I have in my entire life. I have watched him suffer for 5 years and now knowing that I may have caused it leaves me with an undescribable guilt. I have had to strictly monitor his diet not knowing what would trigger an episode resulting in a long night at the emergency room. The least of the damages being all the school and work I have missed. Anyone with children knows what it is like to see your child suffer...its the most helpless feeling in the world. All because my doctor said it was safe.

Posted by
My son was born with congenital hydrocephalus (water on the brain), epilepsy and g-tube fed along with being delayed in many areas. He went through 7 surgeries. He passed away suddenly at the age of 4 due to aspiration while having the flu.
I have always wondered if the paxil I was taking might of had something to do with his disability. I will always feel terrible about it.

Posted by
I have a 3 year old and 3 month old baby whom I took Paxil with their both pregnancies till about 3 months. With my first daughter i changed doctors and moved to a different state. Different doctors had different opinions on the safety of Paxil. I didnt stop taking it till about 3 months into my pregnancy. My 3 month old daughter, i took paxil until my first appointment with a doctor at about 5-6 weeks, until i saw someone to tell me to stop taking it for sure. Its very important that i be on paxil, and don't just stop taking it. I was afraid of weaning off of the paxil. Both of my daughters have a heart murmur, and there is no history in my family of heart defects or heart murmurs.

Posted by
My son has aortic stenosis he was born in 1994. He has had 2 open heart surgeries and several angie grams follows up at childrens hospital.

Posted by
I took paxil 20 mg for depression d/t my daughter's death. The doctor told me that it was very safe to take. So I took it when he was born he had projectile vomiting so at 6 months of age he was sent to madison children's hospital at that time they diagnosed him with no testicles and eventually will have to go on medication for this as well. Then since he has been old enough he has had Terrible temper tantrums and has hurt people with this as well. I am very down, the depression is a lot worse. My oldest son is afraid of him as we don't know when he will blow up and throwing and hitting everyone. Not to mention the expense part of it all and the wear and tear on vehicles . let alone what he feels inside. It is hard for me to think how much financially it has cost us.

Posted by
According to the NICU doctor at CHildren's Hospital in Columbus, Ohio, the heart defect occured the first 10 days after conception. My daughter was born with a heart murmur in which she was sent to Children's Hospital in Columbus, Ohio. She was diagnosed with Ebstein's Anomoly of the tricuspid valve and pumonary stenosis. She slept all the time and it took alomst an hour to feed her 1-2 oz of formula. At times, she appeared a little blue. She spent one week at the hospital for observation and then was sent home. I went to a cardiologist appointment her third week. The doctor at that point did not like what he saw. She was sent back down to Children's. She was dying at this point. All it would have took was a hard cry or some other stressful situation to put her into respiratory and cardiac failure. The third week a balloon was used to open the pulmonary valve. After the procedure, she was a totally different baby. Everything improved drastically after almost losing her for good. She was sent home within a few days with regualr cardiologist appointments. Currently, she is doing fine, but she will always have to be seen by a cardioogist. She will also have to take antibiotics for any surgeries or dental work for the rest of her life. I was told that she will always have to work harder that a normal person to maintain a healthy heart.

After delivering my daughter, I did not get the opportunity to bond with her in my room. I had to go down to the nursery to see her due to various tests being performed on her. I had almost no sleep after being in labor for 25 hours. I was unable to sleep after delivery due to the anxiety of what was wrong with my daughter. I was then discharged less than 15 hours after delivery in order to follow my daughter to Children's Hospital. My family and I had to drive 2 hours to Children's around 1 am after getting no sleep the night before or that day. My daughter was sent by ambulance ahead of us. Since I was discharge early, I did not get all the teaching I would have received normally at the hospital. It was difficult being a first time mother and not knowing what to expect postpartumly. When I arrived at the hospital, I was too tired to do much bonding with my baby. I felt like I had not bonded at all with my daughter the entire first day. The second day was spent at her bedside and worrying about where my family and I were going to stay that night. My parents had to put money out for a place to stay, food, and gas since I had no money. I was a college student and was put on bed rest 20 weeks into my pregnancy. My parents also lost time from work to be there for support. I went through alot of emotional hardship trying to deal with this situation. I went into depression and had thoughts of suicide. I felt like I lost all control over the situation and my daughter's. My future husband and I went through a very rough time due to this situation. We started arguing quite a bit due to the stress. We both felt all this extra burden and weight as new parents. This situation added to that. All of this happened the first week and was repeated the third week. The week in between was full of stress beyond the normal new parent stress. I took almost an hour to feed her 1-2 oz of formula every 3-4 hours. She has to be undressed to keep her awake to feed since it took so much energy for her. She was very fussy. She would also turn blue which would scare me to death. I was only gettin 2-3 hours a sleep a night. The second stay was very scary since my daughter was in a life threatening situation. The following months involved doctors appointments a more worrying. I had to jiggle my schedule for 2 hour appointments at the cardiologist. By this time I was back in school and at work. I had to ask off work in order to make a couple of the appointments. It also ment extra gas. The first few months were very emotional for me. I contantly was checking on her to make sure she was all right. I never new when things were going to change.


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