Eli Lilly developed its Symbyax medication, approved to treat bipolar depression and some cases of major depression, by combining two drugs: an antidepressant and an antipsychotic. The two medications are Prozac and Zyprexa. Symbyax was first approved for use by the U.S. Food and Drug Administration (FDA) in 2003, with expanded approval for other uses in 2009.
Symbyax lawsuits may provide some patients who have used the drug with compensation for the harm it has caused. While for many people the medication has been helpful, and even life-saving, others have experienced serious side effects and complications, including increased suicidal thoughts, birth defects, and death in elderly patients already struggling with dementia. If you or someone you love has been adversely affected by Symbyax, you may want to file a lawsuit against the drug maker.
How Symbyax Works
The FDA originally approved Symbyax to treat the depressive cycles of bipolar disorder, but in 2009 also approved it to be used in people with major depression for whom other treatments have failed. Symbyax contains Prozac, Eli Lilly’s long-running antidepressant fluoxetine, and the antipsychotic Zyprexa, or olanzapine.
Fluoxetine belongs to a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. Low levels of the brain chemical serotonin have been linked to depression, so these drugs work by making sure the brain stays flooded with it. Olanzapine is a second generation, atypical antipsychotic. This means that it works on two brain chemicals: serotonin and dopamine. How the two work together to relieve certain types of depression isn’t well understood. By itself, Zyprexa is used to treat the manic episodes associated with bipolar disorder.
Many of the most common side effects of using Symbyax do not present serious health problems for patients. These include and increased appetite and weight gain, fatigue, tremors, dry mouth, edema, and blurry vision. Some people may also develop high blood sugar, which if not controlled can lead to diabetes.
Weight gain and high blood sugar levels are among the more serious of the common side effects and are triggered by olanzapine. Other antipsychotics cause these effects and have even led to lawsuits. One such case, unfortunately for the plaintiff, went in favor of Eli Lilly. The plaintiff taking Zyprexa died after taking it and developing diabetes. The drug company argued that the plaintiff had a history of diabetes and the death was not related to their medication. More lawsuits over this serious side effect may be seen in the future.
Black Box Warnings and the Potential for Lawsuits
The FDA requires that Symbyax packaging include a black box warning for two rare, but very serious complications. SSRI antidepressants like Prozac are known to increase the possibility of suicidal thoughts and behaviors in young people, typically those under the age of 24. The FDA approved Symbyax to be used in children ten and older, but only for bipolar depression. Any other use in young people is not approved and not recommended.
The other black box warning that comes with Symbyax is the risk that elderly patients with dementia are more likely to die while taking the drug. This warning is related to Zyprexa, which is known to increase the risk of death in this special population. Symbyax is not approved for use in elderly patients who show signs of dementia. Eli Lilly may eventually be facing lawsuits in the cases of elderly patients dying because of Symbyax or Zyprexa.
Lawsuits have been filed against drug companies that make similar medications to the components of Symbyax over these particular risks. Eli Lilly has faced lawsuits because of Prozac and the suicide risk. Many of the plaintiffs in these cases accused the company of not testing the antidepressant well enough and of wrongful death in the cases in which a young person committed suicide. Consolidated cases in Indiana were settled, but for an undisclosed amount.
Birth Defects and Lawsuits
Another important issue with Symbyax is the possibility of birth defects and other complications of childbirth. Fluoxetine is known to carry a risk of birth defects as well as the life-threatening condition called persistent pulmonary hypertension of the newborn (PPHN). Defects seen with Prozac, which may also be possible with Symbyax, include cleft palate, spina bifida, heart defects, and defects of the skull and brain. Mothers who use the drug during pregnancy may also be at an increased risk for premature birth.
Evidence from studies that birth defects are possible on drugs like Prozac and Symbyax have been slow to come, but is now growing. This may mean that more Symbyax lawsuits will be filed in the future by women whose children were born with devastating defects and health problems. The FDA has required that Symbyax carry a warning about PPHN, but this requirement did not come until years after Prozac and Symbyax were on the market. Many women may have taken these medications without understanding the full risks, which could be a reason that lawsuits will increase in the future.
Why File a Symbyax Lawsuit
If you or a loved one suffered from taking Symbyax and you don’t feel you knew the risks before taking it, you may consider filing a lawsuit against Eli Lilly. Whether the issue you have faced was the death of a loved one, the development of diabetes, or birth defects, you have probably had to cope with high medical costs related to them. You may also be looking at years of expensive medical care, permanent health problems, funeral expenses, and the emotional trauma of becoming ill or losing a loved one.
It may be possible to prove that Eli Lilly did not adequately warn patients like you about the risks of taking Symbyax. It may also be proven that the company misrepresented the drug as safer than it really is and more effective, especially when taken during pregnancy. Furthermore, it may eventually be proven that Eli Lilly didn’t test the drug fully, especially for use in pregnant women. With the guidance and advice of a lawyer, you may be able to make a strong case that you deserve compensation.