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.