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What is Symbyax?

Symbyax contains two medicines: olanzapine and fluoxetine. Olanzapine is in a class of medications called "atypical" antipsychotics. Antipsychotic medicines are used to treat symptoms of schizophrenia that may include hearing voices, seeing or sensing things that are not there, mistaken beliefs, and unusual suspiciousness.

Fluoxetine is in a class of medications called Selective Serotonin Reuptake Inhibitors (SSRIs). Fluoxetine is used to treat depression, obsessive-compulsive disorder (OCD), bulimia, and panic disorder.

Symbyax is used to treat adults who have depression with bipolar disorder, a mental illness that causes extreme mood swings.

Symbyax is made by Eli Lilly and Company, and was approved by the U.S. Food and Drug Administration (FDA) in 2003.

Symbyax FDA Alert - Serotonin Syndrome

In July 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can occur when medicines called Selective Serotonin Reuptake Inhibitors (SSRIs, such as fluoxetine) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together. Signs and symptoms of serotonin syndrome include:

  • restlessness
  • hallucinations
  • loss of coordination
  • fast heartbeat
  • increased body temperature
  • fast changes in blood pressure
  • overactive reflexes
  • diarrhea
  • coma
  • nausea
  • vomiting

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Symbyax FDA Alert - Antidepressants and Pregnant Women

In July 2006, the FDA issued an alert announcing the results of a study looking at the use of antidepressant medicines during pregnancy by mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs, and do not get enough oxygen to their bodies. Babies born with PPHN can be very sick and may die. Results from the study also showed that babies born to mothers who took SSRIs 20 weeks or later into their pregnancies had a higher chance (were 6 times as likely) to have PPHN, when compared to babies born to mothers who did not take antidepressants during pregnancy.

The FDA has announced that it plans to further examine the role of SSRIs in babies with PPHN.

Talk to your healthcare professional if you are taking Symbyax and are pregnant, or are planning to become pregnant. You and your healthcare professional can decide the best way to treat your depression during pregnancy.

Symbyax and the Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these medications. Symbyax-maker Eli Lilly and Company has since added a black box warning to Symbyax's prescribing information in response to the FDA advisory. Click here for more information on this advisory.

In June 2005, the FDA issued a public health advisory announcing that several recent scientific publications suggested the possibility of an increased risk for suicidal behavior in adults being treated with antidepressant medications, such as Symbyax. The FDA highlighted that adults taking antidepressants (particularly those being treated for depression) should be watched closely for worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins and when doses are increased or decreased. The FDA is working closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications.

Who Should Not Take Symbyax?

Never take Symbyax while taking another drug that treats depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking these two drugs close in time can result in serious (and sometimes fatal) reactions including high body temperature, coma, and seizures (convulsions).

MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

Never take Symbyax if you are taking Mellaril (thioridazine), a drug used to treat schizophrenia. Taking Symbyax and Mellaril together can cause serious heartbeat problems.

Symbyax Health Risks

In addition to the health risks announced in the FDA alerts (above), there may be other dangers associated with Symbyax use.

The risks of using Symbyax include:

  • An increased risk of having suicidal thoughts or actions
  • Increased chance of death in elderly persons treated with atypical antipsychotics (such as Symbyax) for dementia. Symbyax is not approved for treating dementia.
  • Neuroleptic Malignant Syndrome (NMS), a life-threatening nervous system problem, which can cause high fever, stiff muscles, sweating, fast or irregular heart beat, change in blood pressure, and confusion. NMS can also affect your kidneys and is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
  • Tardive Dyskinesia (TD), a movement problem. Call your healthcare professional right away if you get muscle movements that cannot be stopped.
  • High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
  • Strokes have occurred in older patients treated for mental illness from dementia. Symbyax is not approved for this use.
  • Bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding
  • Mania (becoming hyperactive, excitable, or elated)
  • Low salt levels in the blood, which can cause weakness, confusion, or trouble thinking
  • Sexual problems including impotence (erectile dysfunction), abnormal ejaculation, difficulty in reaching orgasm, or decreased libido (sexual desire)

Other serious side effects of Symbyax use include:

  • Low blood pressure (seen as dizziness), and possible fainting
  • Increased heartbeat
  • Seizures
  • Liver problems
  • Increased body temperature
  • Difficulty swallowing

The most common side effects include

  • Sleepiness
  • Dry mouth
  • Dizziness
  • Restlessness
  • Diarrhea
  • Weight gain
  • Increased appetite
  • Tremor

What Should I Tell My Healthcare Professional?

Before you start taking Symbyax, tell your healthcare professional if you:

  • have or had heart problems
  • have or had seizures.
  • have or had diabetes or increased blood sugar
  • have or had liver disease
  • are trying to become pregnant, are already pregnant, or are breast-feeding.
  • are taking Prozac, Prozac Weekly, Sarafem, olanzapine, Zyprexa, or Zyprexa Zydis. These medicines each contain an ingredient that is also found in Symbyax.
  • drink alcohol

Can Other Medicines or Food Affect Symbyax?

In order to avoid dangerous interactions with any medicines you might be taking, tell your healthcare professional about all prescription and non-prescription medicines, vitamins, and herbal supplements that you take.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medications:

  • blood pressure medicines
  • levodopa and other medicines called dopamine agonists
  • omeprazole
  • rifampin
  • carbamazepine
  • fluvoxamine
  • clozapine
  • haloperidol
  • phenytoin
  • lithium
  • pimozide
  • sumatriptan
  • warfarin

Avoid drinking alcohol while taking Symbyax.

Is There Anything Else I Need to Know?

Dizziness (and sometimes fainting) caused by a drop in blood pressure may happen with Symbyax, especially when you first start taking this medicine or when the dose is increased.

Symbyax may impair judgment, thinking, or motor skills. You should be careful in operating machinery, including automobiles, until you know how Symbyax affects you.

Lastly, it is important to avoid overheating and dehydration while taking Symbyax. Symbyax may make it harder to lower your body temperature.

Symbyax - Getting Legal Help

While most medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions related to Symbyax use, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Symbyax use.

  • Go here to learn more about an attorney's role in a pharmaceutical liability case.
  • To find an experienced attorney, use the "Find a Lawyer" tool on this page, or click here.
Next Steps
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