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Symbyax

The Symbyax injury attorneys at the Drug Law Center have successfully participated in jury trials and negotiated settlements that have resulted in the highest available level of financial compensation for our clients.

Introduction

Symbyax Drug RecallSymbyax (olanzapine and fluoxetine hydrochloride) is an atypical SSRI (Select the Serotonin Reuptake Inhibitor) antipsychotic medication prescribed to treat depression caused by manic-depression (bipolar disorder). The medication is a combination of two different drugs, olanzapine and fluoxetine hydrochloride.

Olanzapine is a psychotropic drug that affects brain chemicals, whereas, fluoxetine hydrochloride is a SSRI antidepressant. The combination has been proven to be highly effective. However, there are serious side effects, warnings, and drug interactions that affect the safety and efficacy of the medication. Many doctors consider Symbyax as an alternative medicine for the treatment of depression when at least two other drugs have been unsuccessful.

The History of Symbyax

Eli Lilly & Company manufactures, promotes and markets Symbyax as an effective treatment for bipolar depression in children and adults. However, the Black Box Labeling has an explicit warning that the product can induce suicidal ideation and suicidal action. In 2003, the FDA approved Symbyax for the treatment of bipolar depression and in 2009 extended that approval to encompass treatment for depression that was resistant to other medications.

Symbyax Side Effects

Like all prescription medications, Symbyax has mild to severe side effects that could affect the health and well-being of the user. The most common side effects associated with taking Symbyax and the generic form olanzapine and fluoxetine hydrochloride include:

  • Feeling tired
  • Drowsiness
  • Dizziness
  • Constipation
  • Dry mouth
  • Weight gain
  • Increased appetite
  • Diarrhea
  • Blurred vision
  • Difficulty in sleeping
  • Swollen feet or hands

The ingredients in Symbyax are known to increase the potential risk of suicidal ideation (thinking about committing suicide) and suicidal behavior. In addition, individuals who take Symbyax or the generic form might be at an increased risk of developing serious side effects that could be fatal. These include heart failure and stroke, especially in elderly individuals with dementia. The most noticeable indicators that the patient is having a serious side effect when taking Symbyax or its generic include:

  • Experiencing severe unusual mood/mental changes that could involve nervousness, confusion, restlessness, and difficulty in concentration.
  • Tremors (shaking)
  • Difficulty in urinating
  • Any change in sexual ability
  • Decreasing libido (loss of interest in sex)
  • Inability to stay still

Who Should Avoid Taking Symbyax?

Symbyax, and the generic form olanzapine and fluoxetine hydrochloride, have specific contraindications. This means patients suffering from specific medical conditions, or taking certain medications, or have an allergic reaction to the ingredients in Symbyax should not take the medication. It is advisable to not take Symbyax until you check with your doctor if you suffer from any of the conditions listed below. These include:

  • Parkinson’s symptoms
  • Neuroleptic Malignant Syndrome
  • Sinus tachycardia
  • Serotonin syndrome adverse drug reaction
  • Transient ischemic attack
  • Tobacco smoking
  • Closed-angle glaucoma
  • Lower seizure threshold
  • Epileptic seizures
  • Abnormal movement of the tongue or facial muscles
  • Prolonged QT intervals
  • Abnormal heart rhythm
  • Very rapid heartbeat
  • Decreased blood volume
  • High blood sugar
  • Weight gain
  • Loss of appetite
  • Heart failure
  • Low blood stream sodium levels
  • Excess body water loss
  • Low blood stream potassium levels
  • Difficulty passing food through the esophagus
  • Enlarged prostate causing urination problems
  • A drop in blood pressure when standing
  • Sudden heart failure
  • Slow heartbeat
  • CYP2D6 poor metabolizer
  • Mild form of mania
  • Thoughts of suicide
  • Manic-depression
  • Increased risk of bleeding
  • Hardening of the liver
  • Severe liver disease
  • Abnormal liver function tests
  • Paralysis of the liver
  • and others

 

Medication Interactions

 

Taking two different drugs concomitantly with one another can cause significant problems, especially if one of them is an antidepressant medication. In addition, data shows there is a significant risk of harm when taking Symbyax as an adjunct treatment with other medications. Some of these drugs include:

 

  • MAOIs (monoamine oxidase inhibitors)
  • CNS acting medications
  • Serotonergic medications
  • Medications that interfere with homeostasis (this could include warfarin, aspirin, NSAIDs)
  • Electroconvulsive therapy (ECT)
  • Benzodiazepines
  • 1A2 inducers
  • CYP1A2 inhibitors
  • Alcohol use

Symbyax and Suicidal Behaviors

The FDA has instructed the makers of Symbyax to add specific warnings to the product’s black box labeling to make consumers aware of the known suicidal thoughts and behaviors associated with all antidepressants including Symbyax. The warning states that the drug can cause “suicidal thoughts and behaviors, and increase mortality in elderly patients with dementia-related psychosis.”

In addition, the label states that in short-term studies “antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over the age of 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.”

The labeling also suggested there is an increase mortality rate in elderly individuals who suffer from dementia-related psychosis being treated with antipsychotic medication. In addition, there is an increased risk of death with these patients. Even though Symbyax is not approved by the FDA to treat dementia-related psychosis, some doctors may be prescribing it off label.

Symbyax and Pregnancy

The Food and Drug Administration has categorized the brand name Symbyax and its generic form olanzapine and fluoxetine hydrochloride as a “Category C” medication. This means that the SSRI antidepressant medication might cause serious lung problems to the fetus if the mother takes the drug during her pregnancy. However, doctors warn expecting mothers that discontinuing Symbyax during pregnancy could cause a relapse of depression. In addition, no female 17 or younger, including pregnant mothers, should take the antidepressant medication because of its serious side effects.

Even though studies have shown that Symbyax is an effective way to treat depression, especially in individuals suffering from bipolar disorder, it is important to note that pregnant women can place their child at risk of developing birth defects when the mother is taking the drug. In addition, the active ingredients in Symbyax, olanzapine and fluoxetine hydrochloride, can cross into breastmilk. Because of that, doctors often advise new mothers to avoid taking Symbyax while breastfeeding.

To date, no studies have been found that show an increased potential of a miscarriage, stillbirth, or preterm birth when taking Symbyax or its generic forms when pregnant. Some studies have shown that newborns can experience withdrawal symptoms from Symbyax when the mother took the medication during the last trimester of her pregnancy. Many of the withdrawal symptoms include agitation, tremor, decreased muscle tone, difficulty in breathing, sleeplessness, and feeding problems.

Symbyax Lawsuits

  • FDA Concerned over Symbyax Link to Life-Threatening Drug Reaction

May 2016 – The U.S. Food and Drug Administration (FDA) has issued a warning over the concern that antipsychotic medications including Symbyax have been linked to serious life-threatening drug reaction with eosinophilia and systemic symptoms.

The serious condition is caused by exposure to specific drugs that produce fever, lymphadenopathy (lymph node disease), rash, internal organ inflammation, and hematological abnormalities including atypical lymphocytosis (enlarged white blood cells), thrombocytopenia (blood platelet deficiency), and eosinophilia (elevated eosinophils levels).

  • FDA Releases Public Health Advisor Warning Consumers to Avoid Taking Symbyax When Pregnant

2011 – An article posted in the New England Journal of Medicine involved a case-control study showing a link between SSRIs antidepressant medications including Symbyax and the increased potential risk of child birth defects including persistent pulmonary hypertension of the newborn (PPHN).

Not long afterward, the Food and Drug Administration released a Public Health Advisory to warn antidepressant users including those taking Symbyax while pregnant had an increased potential risk to the fetus of being born with PPHN, a serious heart defect that causes a failure of the normal circulatory transition characterized by pulmonary hypertension.

Building a Lawsuit to Obtain Financial Compensation

While it might be possible to handle every aspect of your personal injury case, wrongful death lawsuit, medical malpractice suit, or product liability compensation claim, these cases are usually very complex. You will be required to prove how Eli Lilly & Company failed to warn you adequately of the potential risks involved in taking Symbyax. It will be up to you to show how the drugmaker misrepresented their product as being safe and effective when taken, especially during every phase of pregnancy. To win your case, you might be required to prove how the drug manufacturer failed to fully test the medication before making it available in the medical marketplace.

Fortunately, by handing over the case to a reputable personal injury attorney who specializes in product liability cases, you can develop a strong lawsuit to ensure your family receives much-deserved financial compensation.

Our law firm has access to all the necessary resources, research, and studies that prove how birth defects have occurred during fetal development in mothers who have taken Symbyax. Many of these defects include:

  • Atrial Septal Defect (ASD)
  • Coarctation of the Aorta (CoA)
  • Double Outlet Right Ventricle (DORV)
  • Patent Ductus Arteriosus (PDA)
  • Transposition of the Great Arteries (TGA)
  • Hypoplastic Left Heart Syndrome (HLHS)
  • Tetralogy of Fallon (ToF)
  • Ventricle Septic Defect (VSD)
  • Persistent Pulmonary Hypertension of the Newborn (PPHN)
  • Hand deformations
  • Hypoplasia
  • Fetal death
  • Cleft palate and cleft lip
  • Esophageal stenosis
  • Heart murmur
  • Tricuspid valve stenosis
  • Mitral valve defects
  • Ebstein’s anomaly
  • Craniosynostosis
  • Hydrancephalopathy
  • Hydronephrosis
  • Undescended testicles
  • Down syndrome
  • Mental retardation

Presenting evidence during the Symbyax lawsuit trial can hold the drug manufacturer socially responsible for marketing and effective drug. The attorney presenting the case will likely base their lawsuit on a failure to warn the plaintiff of all the serious Symbyax side effects that occur during pregnancy.

Are You Ready to File Your Symbyax Lawsuit?

The Symbyax injury attorneys at the Drug Law Center have experienced trial lawyers that fight aggressively when representing plaintiffs in Symbyax lawsuits. We are currently accepting antidepressant medication lawsuits and compensation claims to ensure our clients obtain financial station they deserve.

If you suffered serious injury or loss of a loved one after they took Symbyax and do not believe you were made aware of the potential risks before you took the drug, you are likely entitled to receive financial compensation in a lawsuit against Eli Lilly & company. We can build your case on the harm you received from a birth defect, the development of diabetes, or other serious side effects that serious damages including extensive medical bills, lost wages, pain and suffering.

We will fight on your behalf to ensure you receive the compensation you need to fully financially recover from permanent health issues, funeral expenses, expensive medical care, ongoing therapy, and future surgical procedures. In addition, we will seek financial recovery for your noneconomic damages including pain, suffering, mental anxiety, emotional distress, and grieving.

Contact us today so we can begin the process of working on your behalf. We provide comprehensive consultations to discuss the merits of your case, at no cost to you. In addition, we will postpone accepting payment for our legal services until after we successfully resolve your case by winning your jury trial, or negotiating an acceptable out-of-court settlement.

Sources:
http://www.mayoclinic.org/drugs-supplements/olanzapine-and-fluoxetine-oral-route/description/drg-20071357
http://www.mdedge.com/ccjm/dsm/7683/drug-therapy/olanzapine-and-fluoxetine
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21520_symbyax_lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021520s022lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021520s017lbl.pdf