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Symbyax Overview
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 prescribed for the treatment of the depressive phase of bipolar disorder. Virtually all patients with this disorder experience the depressive phase commonly referred to as bipolar depression. Patients with bipolar disorder spend an average of one-third of their lives in the depressive phase of this illness. 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:
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.
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.
What Should I Tell My Healthcare Professional?
Before you start taking Symbyax, tell your healthcare professional if you:
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:
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.
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