Symbyax (fluoxetine and olanzapine) is a prescription antidepressant that is intended to assist in the treatment of several major depressive disorders and generalized anxiety. However, a unique combination formula allows Symbyax to treat a number of related psychotic disorders as well. Unfortunately, the introduction of Symbyax to a developing fetus may result in catastrophic complications. Pregnant women who receive Symbyax treatment may significantly increase their risk of having a child with a distinct set of severe, life-threatening birth defects. Subsequently, families affected by these birth defects may be entitled to compensation through their own Symbyax lawsuit.
If you or a loved one has given birth to a child with congenital birth defects that you feel may be the result of taking Symbyax during pregnancy, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Symbyax Lawsuit Overview
Eli Lilly, a world renown pharmaceutical company, introduced Symbyax to the U.S. market on December 24, 2003. The combination prescription medication became the first antidepressant approved by the U.S. Food and Drug Administration (FDA) for acute treatment of treatment-resistant depression (TDR) and bipolar depression in adults. Symbyax combines olanzapine, an atypical antipsychotic, with fluoxetine, a selective serotonin reuptake inhibitor (SSRI).
As an SSRI, fluoxetine is believed to influence specific aspects of an individual’s mood by increasing the ratio of serotonin in the brain. While the chemical reactions associated with mood disorders remain ambiguous, it is widely recognized that chemical messengers (neurotransmitters) facilitate communication between nerve cells in the brain and are involved in regulating many aspects of behavior. Subsequently, these neurotransmitters have a significant role in the development of mood disorders. Therefore, fluoxetine is specifically designed to block the reabsorption of serotonin in the brain. In doing so, larger amounts of serotonin are able to stimulate nerve cells and influence the mood of an individual.
Olanzapine is classified as a thienobenzodiazepine. The mechanism of action of such drugs are unknown, however it is generally theorized that olanzapine’s antipsychotic activity is mediated primarily by antagonism at dopamine receptors. Olanzapine has been FDA approved for the treatment of schizophrenia, acute mania in bipolar disorder, agitation associated with schizophrenia and bipolar disorder, and as maintenance treatment in bipolar disorder.
Unfortunately, the pharmacodynamics of Symbyax may also be responsible for a variety of congenital birth defects with varying degrees of severity. Pregnant women who receive Symbyax treatment may significantly increase their risk of giving birth to a child with distinct set of severe, life-threatening anatomical defects. Due to the severity in which these birth defects harm children, patients may contact a Symbyax lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential lawsuit.
Symbyax Birth Defects
The following is a comprehensive list of Symbyax birth defects:
- Atrial Septal Defects
- Ventricular Septal Defects
- Ebstein’s Anomaly
- Mitral Valve Defects
- Transposition of the Great Arteries
- Tetralogy of Fallot
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Valve Stenosis
- Tricuspid Atresia
- Aortic Stenosis
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Heart Murmur
- Pulmonary Stenosis
- Pulmonary Atresia
- Gastroschisis – abdominal wall defect
- Esophageal Stenosis
- Esophageal Atresia
- Anal Atresia
- Spina Bifida
- Heart Malformations
- Neural Tube Defects
- Hand Deformations
- Cleft Lip
- Cleft Palate
- Fetal Death
- Growth Restriction
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Mental Retardation
- Down’s Syndrome
- Dandy Walker Syndrome
- Undescended Testicles
- Cloacal Exstrophy
New England Journal of Medicine PPHN Study
In 2006, the FDA issued a warning about the heart defects risk caused by using antidepressants during pregnancy. According to the study published in the New England Journal of Medicine, women who use selective serotonin reuptake inhibitors (SSRIs) such as Symbyax are much more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN). In the study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. Do to the severity of PPHN, families may seek compensation for their suffering by filing a Symbyax lawsuit.
This study focused primarily on PPHN, a condition in which a serious and life-threatening lung condition occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care.
According to a similar study published in the British Medical Journal, women who take SSRI antidepressants late in pregnancy are two times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN).
PPHN is a rare but extremely serious birth defect that sometimes occurs in newborn babies. Newborns with PPHN typically develop severe respiratory failure shortly after delivery. Even with proper medical treatment, 10 to 20% of infants with primary pulmonary hypertension will not survive.
Symbyax Heart Defects
Recent evidence lends weight to the long-suspected link between Symbyax and severe, life-threatening heart defects. Studies suggest that the pharmacodynamics of Symbyax may have a negative affect on the development of the fetal heart. Subsequently, adverse Symbyax heart defects are responsible for several complications with varying degrees of severity. While minute defects may occur, they have a propensity to cure themselves. However, severe defects may lead to a number of catastrophic complications that interfere with the child’s life in a profound way. More often than not, congenital heart defects can significantly disrupt the flow of blood through the circulatory system. As a result, the blood is unable to acquire the necessary amount of oxygen from the lungs to disperse throughout the body. Subsequently, the body’s demand for oxygen is not met and the individual may suffer fatal circumstances if the problem is not addressed.
FDA Antidepressant Warning
In 2004, the FDA issued a warning pertaining to the use of certain antidepressants in women who are, or may become pregnant. The warning stated that doctors may want to taper expecting mothers off antidepressant medications in the third trimester to reduce the risk of congenital birth defects. However, recent studies suggest that women treating depression with SSRI’s like Symbyax as early as the first trimester of pregnancy may still have an impact on the unborn child. Unfortunately, this means many women may be unaware that they are pregnant while on a prescribed Symbyax treatment regiment. As a result, women may be unintentionally subjecting their child to these unnecessary risks of congenital birth defects. These risks have caused numerous people to file a Symbyax lawsuit against Eli Lilly.
Do I Have a Symbyax Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Symbyax lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has given birth to a child with congenital birth defects that you feel may be the result of taking Symbyax during pregnancy, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.