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Symbyax FAQs

Q: What is Symbyax?

Symbyax contains two medicines: olanzapine and fluoxetine. 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.

Q: What is olanzapine?

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, or unusual suspiciousness.

Q: What is fluoxetine?

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.

Q: Has there been any recent news about Symbyax?

In July 2006, the FDA issued two alerts related to Symbyax. The first FDA alert announced the results of a study concerning the use of antidepressant medicines during pregnancy by mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). The second FDA alert states that a life-threatening condition called serotonin syndrome can occur when SSRIs (such as fluoxetine) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together.

Over the last few years, the FDA has worked closely with the manufacturers of all marketed antidepressants (such as Symbyax) to fully evaluate the risk of suicidality in children, adolescents, and adults treated with these medications. Symbyax maker Eli Lilly and Company added a black box warning to Symbyax's prescribing information describing the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressants.

Q: Who should not take Symbyax?

You should not take Symbyax if you take 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).

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.

Q: Are there any serious health risks associated with Symbyax?

Health risks associated with Symbyax use include an increased risk of having suicidal thoughts or actions; increased chance of death in elderly persons treated with Symbyax for dementia (Symbyax is not approved for treating dementia); Neuroleptic Malignant Syndrome (NMS) (a life-threatening nervous system problem); Tardive Dyskinesia (TD) (a movement problem); high blood sugar and diabetes; strokes in older patients treated for mental illness from dementia; bleeding problems, mania; low salt levels in blood; and sexual problems.

Q: Are there any side effects associated with Symbyax?

Serious side effects associated with Symbyax use include low blood pressure (seen as dizziness or possible fainting), increased heartbeat, seizures; liver problems; increased body temperature; and difficulty swallowing.

The most common side effects associated with Symbyax use include sleepiness, dry mouth, dizziness, restlessness, diarrhea, weight gain, increased appetite, and tremor.

Q: What should I tell my healthcare professional before he or she prescribes Symbyax?

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 Symbyax, Prozac, Prozac Weekly, Sarafem, olanzapine, Zyprexa, or Zyprexa Zydis; or drink alcohol.

Q: Can other medicines or foods affect Symbyax?

It is important to 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; or warfarin. Avoid drinking alcohol while taking Symbyax.

Q: Is there anything else I need to know about taking Symbyax?

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. Also, 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.

Q: What should I do if I think I have been injured from taking Symbyax?

Many serious injuries have been linked to the use of Symbyax, particularly birth injuries to children whose mothers were taking the drug. If this has happened to you, once you've talked to your doctor, it may be in your best interests to have an experienced product liability attorney review the facts of your case for free. This can help you protect your right to a legal remedy for any injuries caused by Symbyax use.

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