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Symbyax

Symbyax is a prescription medication to treat adults who have depression with bipolar disorder, a mental health condition that causes extreme mood swings. Eli Lilly and Company manufactures Symbyax, and the U.S. Food and Drug Administration (FD) approved the medication in 2003.

Symbyax consists of two drugs: olanzapine and fluoxetine. Olanzapine is an "atypical" antipsychotic medicine, meaning it's used to treat symptoms of schizophrenia such as hearing voices, seeing things that aren't there, mistaken beliefs, etc. Other atypical antipsychotic medications you can read about in the FindLaw Dangerous Drugs section include Zyprexa and Risperdal. Fluoxetine is a Selective Serotonin Reuptake Inhibitors (SSRIs) and is used to treat depression, obsessive-compulsive disorder (OCD), bulimia, and panic disorders. To learn more, read the Symbyax FAQs

Symbyax and Serotonin Syndrome

The FDA issued an alert to doctors and the public in July 2006 informing them that a life-threatening condition  can occur when Selective Serotonin Reuptake Inhibitors (SSRIs) and migraine medications known as 5-hydroxytrypatmine receptor agonists (triptans) are taken together. This condition is called "serotonin syndrome." 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 doctor if your medicine is a triptan.

Antidepressants and Pregnant Women

In July 2006, the FDA issued a separate alert announcing the results of a study looking at the use of antidepressant medicines during pregnancy by moms 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 don’t 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 didn’t take antidepressants during pregnancy. For more information, see the Antidepressants and Pregnancy article. Talk to your doctor if you are taking Symbyax and are pregnant, or are planning to become pregnant. You and your doctor 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. Eli Lilly and Company, the maker of Symbyax, has since added these warnings 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 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 has worked closely with antidepressant manufacturers to fully evaluate the risk of suicidality in adults treated with these medications.

Getting Legal Help

While most medications have certain anticipated side effects, drug manufacturers have a duty to make their products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with their drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as a 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 detrimental side effects from taking Symbyax, you should first contact your doctor. You may also want to consult with a product liability attorney to protect your right to compensation for any Symbyax related injuries. To learn more about an attorney's role in a pharmaceutical liability case, read the Get Legal Help with a Defective Product Injury article.

Next Steps
Contact a qualified product liability attorney to make sure
your rights are protected.
(e.g., Chicago, IL or 60611)

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