Symbyax is a combination drug developed and manufactured by Eli Lilly to treat bipolar disorder and certain cases of major depressive disorder. One component of the drug is Prozac, an antidepressant that has been on the market since the late 1980s. The other is the antipsychotic drug Zyprexa. Symbyax is sometimes a last-resort drug for people struggling with mental health conditions, but it also presents a lot of potential problems.
Symbyax may cause suicidal thoughts or actions in young people; it may increase the risk of dying in some elderly patients; and it can cause several other serious conditions with lasting consequences. One of these is birth defects in the children of mothers who took the medication during pregnancy. It is this last issue that has caused the most controversy and has made Eli Lilly the subject of several lawsuits. If you have been harmed by Symbyax, you too may want to sue the company to recover monetary damages.
What is Symbyax?
Symbyax is a combination of one of Ely Lilly’s best-selling antidepressants, Prozac, and an antipsychotic called Zyprexa. Prozac is the generic drug fluoxetine, which was first approved by the U.S. Food and Drug Administration (FDA) to be used to treat depression in 1987. Alone, Prozac can also treat anxiety disorders, some eating disorders, and premenstrual dysphoric disorder. It is one of the most popular antidepressants of all time.
Zyprexa is the generic drug olanzapine and is a second generation, atypical antipsychotic. Alone, Zyprexa is used to treat schizophrenia and manic episodes of bipolar disorder. This medication has been on the market since the late 1990s and since 2011 has been available in generic form.
Eli Lilly combined the two medications to create Symbyax. It was approved by the FDA in 2003 to treat the depressive episodes of bipolar disorder. In 2009 the FDA approved it to treat depression in people who did not see results from other types of treatment. Off-label, doctors may prescribe it for anxiety disorders, eating disorders, or post-traumatic stress disorder.
How it Works
Fluoxetine is a type of antidepressant called a selective serotonin reuptake inhibitor (SSRI). These drugs work in the brain by acting on receptors and preventing the reuptake, or recycling, of the neurotransmitter serotonin. This is a brain signaling chemical and low levels of it are associated with depression. By increasing the amount circulating in the brain, fluoxetine relieves symptoms of depression.
Olanzapine is an atypical antipsychotic, which means that it acts on serotonin and dopamine in the brain. Exactly how these drugs work or relieve symptoms is well understood. They block these two neurotransmitters and that has the effect of relieving symptoms associated with mania and schizophrenia in most people.
The most common side effects of Symbyax are not serious unless they persist or are severe or intensify over time. Most of these are simply the body adjusting to the drug and should decrease or go away entirely with time. They include weight gain, increased appetite, sleepiness, tremors, fatigue, blurry vision, edema, dry mouth, and inability to pay attention. In children and teens the possible side effects are similar, but may also include an increase in liver enzymes and triglycerides, and these may be more severe. Weight gain is a common side effect of antipsychotics, but is most extreme with olanzapine.
Some of the more potentially serious side effects of Symbyax include hyperglycemia, or high blood sugar, which can lead to metabolic syndrome or type 2 diabetes if not treated. Elevated triglyceride levels in children can also have long-term health consequences if not addressed. Although rare, neuroleptic malignant syndrome is possible with Symbyax. It is life-threatening and is characterized by changes in blood pressure, muscle tightness and pain, mental distress, and an irregular heartbeat.
Suicide, Elderly Patients, and the Black Box Warning
A black box warning is required by the FDA on the labels of drugs that have the potential to cause side effects that are severe or life-threatening. Like other drugs that contain SSRI antidepressants, the FDA requires such a warning on Symbyax to inform patients of the risks of increased suicidal thoughts and actions in young people, especially under the age of 24.
Symbyax is only approved and indicated for use in children ten and older, and only for treating bipolar depression. Children under 18 are not supposed to be given this drug to treat major depression. Even using it for bipolar depression in this population is risky and should be considered only if the benefits outweigh the potential risks.
The black box warning on Symbyax also includes a statement that this drug may increase the risk of death in elderly patients who have dementia-related psychosis. Olanzapine, the antipsychotic, like other drugs in its class is the component of Symbyax that causes this effect. Patients who fit this description should not be given this medication.
SSRIs like Prozac can cause a serious and life-threatening condition called serotonin syndrome. This occurs when the brain is flooded with too much serotonin and the signs of it are hallucinations, anxiety, nausea, diarrhea, vomiting, overheating, agitation, an irregular heartbeat, and coma. Serotonin syndrome may be triggered by Symbyax use and it should be treated immediately.
One of the most serious and controversial possible complications of using Symbyax is the increased risk for birth defects. Fluoxetine carries a small risk of causing birth defects and other problems including spina bifida, heart defects, skull and brain defects, a cleft palate, premature birth, and persistent pulmonary hypertension of the newborn, a serious and life-threatening condition characterized by the infant being unable to breathe outside the womb.
Reports have been made for years of birth defects in the children of women who used an antidepressant during pregnancy, but studies have been few and far between. More recent research is now finding more concrete evidence that this is a possible complication. In light of the evidence, women and their doctors are urged to carefully weigh benefits and risks before using Symbyax or any other antidepressant during pregnancy.
Eli Lilly and other companies that make SSRI antidepressants and antipsychotics have been sued over some of the very serious side effects that have impacted the lives of patients using these drugs. Accusations include that the companies did not do enough to warn patients and doctors of the risks, that they knowingly marketed drugs with serious side effects, and that clinical trials were not adequate to uncover the risks.
If you have been harmed by taking Symbyax, there is time to file a lawsuit and seek compensation from Eli Lilly. The drug company may have hidden information about risks or may have marketed their drug to make a profit in spite of knowing the risks. If you can prove these things with the help of a lawyer, you may be able to get compensation for your suffering.