Manufactured by Glaxo Smith Kline (GSK), Paxil (paroxetine) is used to treat depression, social anxiety disorder, panic disorder, and obsessive compulsive disorder. This drug belongs to the class of antidepressants called serotonin reuptake inhibitors (SSRI). Paxil was approved by the U.S. Food and Drug Administration (FDA) for use by the public in December 1992 and has brought GSK more than $11.6 billion in sales. However, according to multiple studies, Paxil may also increase the risk of birth defects if taken during pregnancy.
Results of Birth Defect Studies
A study published in 2006 from the New England Journal of Medicine showed that taking SSRIs such as Paxil in the first trimester of pregnancy may double the risk of most serious birth defects, particularly Persistent Pulmonary Hypertension (PPHN). This is a life- threatening lung condition in which babies will have high pressure in their blood vessels and are unable to get adequate oxygen into their bloodstream.
Results of the study show that newborns whose mothers used SSRIs for over twenty weeks during their pregnancy were six times more likely to suffer PPNH than the control group which was not using the drugs.
A study published in the 2009 British Medical Journal stated that mothers taking SSRIs during the first trimester had double the chance of giving birth to an infant with septal heart defects when compared to mothers that were not taking the antidepressants. An atrial septal defect is a hole in the wall (septum) separating the left and right upper chambers of the heart. A ventricular septal defect is a hole or defect in the septum in the lower chambers.
The FDA has required that this drug be relabeled from a Class C drug to a Class D drug which indicates that taking Paxil while pregnant may harm the fetus.
A more recent study led by researchers at the Beth Israel Deaconess Medical Center not only confirmed the earlier findings by NEJM, but also suggests that there may be an elevated risk of long-term neurobehavioral abnormalities, including autism with the use of antidepressants during pregnancy.
Data also suggests that using these antidepressants can increase pregnancy induced hypertension, preeclampsia, and premature birth.
Their recommendation is that doctors should use “great caution” and counseling if prescribing these medications to women that are pregnant or are planning to become pregnant. The researchers also found little evidence that taking Paxil and other SSRIs were any more effective in treating depression than taking placebos.
How Does Paxil Work?
Paxil affects chemicals in the brain that may become unbalanced. This drug is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).
SSRIs affect neurotransmitters, the chemicals that nerves within the brain use to communicate with each other. Thus, neurotransmitters can be thought of as the communication system of the brain.
Serotonin is one neurotransmitter that is released by nerves in the brain, and is considered to be the neurotransmitter that is most critical for maintaining mental health.
Many experts believe that an imbalance among neurotransmitters is the cause of depression. Paxil works by preventing the reuptake serotonin, by nerve cells after it has been released. Since reuptake is an important mechanism for removing released neurotransmitters and terminating their actions on adjacent nerves, the reduced uptake caused by paroxetine increases free serotonin that stimulates nerve cells in the brain.
Side Effects of Paxil
Despite its effectiveness, Paxil can have dangerous side effects especially if used by patients who are younger than 24. Taking this drug along with other medications can intensify its effects. Be sure to tell your physician if you are taking other prescribed or over the counter drugs. Some side effects include:
- Increased depression and anxiety
- Agitation or aggression
- Bone pain, tenderness, swelling or bruising
- Bleeding from the nose, mouth, vagina, or rectum
- Hallucinations or confusion
- Rapid heart rate
- Nausea and vomiting
In addition to these serious complaints, certain birth defects have been linked to the use of Paxil during pregnancy.
Birth Defects Linked to SSRIs
Several studies have shown a serious risk of birth injury among babies exposed to Paxil in utero. Among these risks are the complications that can occur due to premature delivery of a fetus.
- PPHN –a serious lung condition that is life-threatening and develops shortly after birth
- Atrial septal defects (ASD)- defect in the septum of the heart
- Ventricular septal defects (VSD) – defect in the septum of the heart
- Clubbed foot – one or more foot turned inward at the ankle
- Cleft lip or palate – either the upper lip does not fuse totally or the roof of the mouth is not connected to the nasal cavity
- Spina bifida – spinal cord protrudes through a gap in the bones
- Delayed development
- Enlarged heart
- Anal atresia
- Limb reduction defects
If you or someone you know took the medication Paxil while pregnant, you could qualify for a Paxil lawsuit. In multiple studies, Paxil has been shown to cause birth defects in infants when the mother took Paxil at any time throughout the pregnancy. If you took Paxil and your child was born with defects, you are eligible for a Paxil Lawsuit.
If a woman becomes pregnant or is planning be become pregnant while taking Paxil (paroxetine), she should discuss the risks of potential harm to the fetus with her physician. They will advise her whether or not the benefits of continuing with Paxil justify continuing treatment or if she should consider a different treatment option.
Birth Defect Studies
According to the National Institute of Health, there is some concern about the risks of serious and potentially fatal birth defects among babies born to mothers that have taken Paxil or other SSRIs during the gestation period. Studies show that infants that were exposed in the first trimester of pregnancy appear to have an increased risk of congenital malformation such as cardiovascular malformations. The primary cardiovascular defects were ventricular septal defects (VSDs) and atrial septal defects (ASDs). Many of the defects will require surgery to repair.
Two large studies found a 2 to 3 fold increased risk of right ventricular outflow tract obstructions associated with maternal use of Paxil during the first trimester.
The FDA has issued a safety warning based on studies which indicate that the use of selective serotonin reuptake inhibitor (SSRI) antidepressants such as Paxil, during pregnancy may have a potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN).
PPHN occurs when a newborn baby is unable to breathe on their own. Newborns diagnosed with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. PPHN can result in multiple organ damage, including brain damage, and even death.
The risk of developing certain birth defects is greatly increased by taking Paxil. Birth defects linked to the use of Paxil during pregnancy include:
- Atrial septal defects (ASD)
- Ventricular septal defects (VSD)
- Persistent pulmonary hypertension of the newborn (PPHN)
- Anal atresia
- Limb-reduction defects
Fill Out This Form for More Information
For more information on Paxil lawsuits, fill out the contact form on this page. You will be contacted to arrange for your free consultation. Our birth defect attorneys have experience assisting families and children affected by the use of Paxil and other SSRIs. You and your child may be eligible for compensation. Paxil injuries may have left your family with excessive medical expenses, lost wages, long term care, as well as pain and suffering. Fill out the form today and let us help.
If you took the medication Paxil while pregnant, you could qualify for a Paxil lawsuit. In multiple studies, Paxil has been shown to cause serious birth defects. If you took Paxil and your child was born with certain complications, you may be eligible for compensation. The U.S. Food and Drug Administration (FDA) has issued a safety warning that using Paxil during pregnancy carries a risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn. (PPHN).
What is Paxil
Paxil (paroxetine) is an antidepressant belonging to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine was approved by the FDA for use by the public in December 1992. Paxil affects chemicals in the brain that may become unbalanced. Paxil is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Paroxetine affects neurotransmitters, the chemicals that nerves within the brain use to communicate with each other. Thus, neurotransmitters can be thought of as the communication system of the brain. Serotonin is one neurotransmitter that is released by nerves in the brain, and is considered to be the neurotransmitter that is most critical for maintaining mental health.
Many experts believe that an imbalance among neurotransmitters is the cause of depression. Paroxetine works by preventing the reuptake serotonin, by nerve cells after it has been released. Since reuptake is an important mechanism for removing released neurotransmitters and terminating their actions on adjacent nerves, the reduced uptake caused by paroxetine increases free serotonin that stimulates nerve cells in the brain.
Paxil Side Effects
Despite its effectiveness, Paxil has dangerous side effects especially if used by patients who are younger than 24. When taken alongside other medication, it may have intense side effects too thus the physician should find out if a patient is using any other medication at the time of prescribing Paxil. Other patients will experience side effects like more depression and anxiety, hyperactivity, agitation and aggressiveness. For some, Paxil causes more serious side effects including;
- unusual bone pain or tenderness, swelling or bruising;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), coughing up blood;
- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, overactive reflexes, feeling like you might pass out;
- nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
- headaches, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.
In addition to these side effects, the FDA has issued a public health advisory which warned both consumers and health care professionals that Paxil had previously been linked to some serious side effects when used during pregnancy, including life-threatening birth defects. The FDA has not calculated an official estimate of women and children at risk, but the number is certain to be high, as millions of Paxil prescriptions are filled every year.
Should You File a Paxil Lawsuit?
It is imperative that you file your Paxil lawsuit now if you want compensation for what you and your family have gone through. Interestingly, it has been found that women taking Paxil are advised to continue with the prescription if they fall pregnant while taking the drug. They are however told to cease taking the drug when they are nursing. These measures are taken to prevent withdrawal symptoms in a pregnant woman, as these can often be severe. Unfortunately, this does not protect the unborn child and many mothers continue taking Paxil unaware of the consequences for her child.
Our attorneys are here to help you with all aspects of your Paxil lawsuit and fight to hold the drug company responsible for what their medication has done. Once you fill out the information for your free Paxil lawsuit evaluation, we can get started helping you get everything you are owed. Although a Paxil lawsuit may not bring back the life or health of your child, it could prevent another from suffering the same predicament.
There may be a statute of limitations to file your Paxil claim so you don’t want to delay. Fill out the form on this page for your free confidential consultation. Our lawyers will review your case and guide you through the entire legal process.