What is Symbyax?

Symbax is a combination of olanzapine and fluoxetine. Olanzapine in an atypical antipsychotic drug used for the treatment of schizophrenia; and fluoxetine is a Selective Serotonin Reuptake Inhibitor (SSRI) and is used for treatment of obsessive-compulsive disorder (OCD), depression, panic disorder and bulimia.

Symbax is usually used for treatment of adults who have depression with bipolar disorder. It is made by Eli Lilly and Company and approved by the US Food and Drug Administration (FDA) in 2003.

FDA Alert on Symbyax – Serotonin Syndrome

The US FDA issued an alert in July 2006, warning of the possible development of a life-threatening condition called serotonin syndrome which may be caused by Selective Serotonin Reuptake Inhibitors (SSRI) such as in Symbax, if they are taken with migraine medications such as 5-hydroxytryptamine receptor agonists (triptans).

Signs and symptoms of serotonin syndrome include:

• Vomiting
• Nausea
• Diarrhea
• Fast heartbeat
• Restlessness
• Fast changes in blood pressure
• Hallucinations
• Loss of coordination
• Increased body temperature
• Overactive reflexes
• Coma

Serotonin syndrome is more likely to occur at the start or increase of the dose of an SSRI or a triptan. Make sure to inform your healthcare professional if you are taking triptan before taking Symbax.

FDA Alert on Symbyax – Antidepressants and Pregnant Women

In the same month as the alert for the serotonin syndrome, FDA issued another alert in response to a result of a study on the effects on their babies of the use of antidepressants by pregnant women. It has been found that such babies will most likely be born with a very serious condition persistent pulmonary hypertension of the newborn (PPHN).

PPHN is a very serious condition and may even cause deaths in infants afflicted with it because it causes an abnormal flow to the heart and lungs, resulting in an insufficient amount of oxygen supply in these organs. The FDA said they will conduct further studies to find out the effects of taking SSRIs while pregnant to the newborn babies.

If you are pregnant or have plans of conceiving, discuss it with your healthcare provider before taking Symbax.

Symbyax and the Increased Risk of Suicidality

The FDA issued an advisory in October 2004, directing all manufacturers of antidepressants to make changes on their products’ labels and include a 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. Eli Lilly complied with this and included a boxed warning indicating such on Symbax packaging.

Another announcement was made by the FDA in June 2005 to let the public know of what scientific publications have to say about the effects of antidepressants such as Symbax. These publications have suggested that there may be an increased risk of suicidal behavior in adults taking such medications. The FDA recommends that such individuals should be closely watched for signs of worsening of their depression and increase in suicidality, especially at the start of the medication, or when changes in the dosage is administered.

Who Should Not Take Symbyax?

There are some people who are advised to not take Symbax, such as those who are already taking another medication for treatment of depression such as Monoamine Oxidase Inhibitor (MAOI), or if MAOI has been taken within the last 14 days prior.

Some examples of MAOI drugs are:

• Marplan (isocarboxazid)
• Nardil (phenelzine sulfate)
• Parnate (tranylcypromine sulfate)

Symbax can react to MAOI and may sometimes cause:

• High body temperature
• Seizures (convulsions)
• Coma

Just the same, MAOI should not be taken within 5 weeks of taking Symbax.

Symbax should never be taken with the schizophrenia treatment called Mellaril (thioridazine). Mellaril should not be taken within 5 weeks of taking Symbax. These two drugs, when taken together within a close period may result in certain heart problems.

The risks of using Symbyax include:

• Mania (becoming hyperactive, excitable, or elated)
• 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
• Sexual problems including impotence (erectile dysfunction), abnormal ejaculation, difficulty in reaching orgasm, or decreased libido (sexual desire)
• Neuroleptic Malignant Syndrome (NMS), a life-threatening nervous system problem, which can cause high fever, stiff muscles, sweating, fast or irregular heartbeat, 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.
• High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
• Low salt levels in the blood, which can cause weakness, confusion, or trouble thinking
• Tardive Dyskinesia (TD), a movement problem. Call your healthcare professional right away if you get muscle movements that cannot be stopped.
• 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.

Other serious side effects of Symbyax use include:

• Diarrhea
• Difficulty swallowing
• Dizziness
• Dry mouth
• Increased appetite
• Increased body temperature
• Increased heartbeat
• Liver problems
• Low blood pressure (seen as dizziness), and possible fainting
• Restlessness
• Seizures
• Sleepiness
• The most common side effects include
• Tremor
• Weight gain

What Should I Tell My Healthcare Professional?

Before you start taking Symbyax, let your doctor know if you:

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

Can Other Medicines or Food Affect Symbyax?

Consult with your doctor before taking Symbax if you are taking any other prescription or non-prescription medications, vitamins, or herbals supplements.

Your doctor may adjust the dosage of your medication or more closely observe you if you are taking any of the following:

• Blood pressure medicines
• Carbamazepine
• Clozapine
• Fluvoxamine
• Haloperidol
• Levodopa and other medicines called dopamine agonists
• Lithium
• Omeprazole
• Phenytoin
• Pimozide
• Rifampin
• Sumatriptan
• Warfarin

Avoid drinking alcohol while taking Symbyax.

Is There Anything Else I Need to Know?

The sudden drop in blood pressure that may occur when you take Symbax may cause dizziness and, at times, fainting. This is especially so if you are taking Symbax for the first time or if the dosage has been increased.

Symbax also affects thinking, judgment or motor skills that’s why it is important to take precautions before operating machinery and vehicles if Symbax affects you in this way.

Symbax may also affect the regulation of body temperature so it is important to take necessary steps to avoid dehydration or overheating while taking this drug.

Symbax – Getting Legal Help

Even if most medicines are expected to have side effects, it is the duty of the manufacturer of these medicines to inform the medical community and the public of known risks associated with the drugs they produce. Failure to give adequate warning to the public and the medical community of the dangers of the drug makes the manufacturer liable under product liability for any injury that may be caused by their product.

If you or your loved one has suffered any of the dangerous symptoms or unusual reaction after taking Symbax, go to your doctor or the hospital as soon as possible. You may also consider consulting with an experienced attorney in order to get more information regarding your rights and possible remedies for the injuries you suffered because of the use of Symbax.