Symbyax is a combination medication containing the active ingredients found in Prozac (an SSRI antidepressant) and Zyprexa (an atypical antipsychotic). Both of these medications have been linked to a number of serious side effects, including suicidality, diabetes and birth defects.

What is Symbyax?

Symbyax is manufactured by Eli Lilly & Co., which also markets Prozac and Zyprexa. The drug maker brought Symbyax to market in 2003, when the U.S. Food & Drug Administration (FDA) initially approved the medication to treat depressive episodes associated with bipolar disorder. In 2009, the approved indications for Symbyax were expanded to include the treatment of depression in adults who have already unsuccessfully tried two other medications.

Symbyax Black Box Warnings

  • Use in Children: Symbyax should not be given to a child younger than 10 years old. A Black Box Warning on the Symbyax label cautions that the medication may cause suicidal ideation in children, teens and young adults (ages 18 to 24).
  • Elderly Adults: The Symbyax Black Box also warns that the medication should not be used to treat elderly patients with dementia. Symbyax nearly doubles the risk of death in these patients, and may increase their risk for a stroke or mini-stroke. Older patients are also at risk for hyponatremia, a condition where there is too little salt in the blood.

Symbyax and Pregnancy

Symbyax has been placed in Pregnancy Category C by the FDA, which indicates that risk to a developing fetus can not be ruled out.

In 2006, the FDA alerted the public to a possible association between SSRI antidepressants like Prozac, one of the ingredients in Symbyax, and persistent pulmonary hypertension of the newborn (PPHN). However, a later FDA alert indicated that studies published since 2006 have produced conflicting findings regarding a link between SSRIs and PPHN.

A number of studies have also suggested that the use of SSRIs in pregnancy may increase the risk for certain birth defects, including septal heart defects, an abdominal wall birth defect called Omphalocele, and a skull defect called Craniosynostosis. A recent study also found that children exposed to SSRIs during the last two trimesters of pregnancy were 117% more likely to be diagnosed with autism spectrum disorder.

Other Serious Symbyax Side Effects

Other Symbyax side effects may include:

  • Neuroleptic Malignant Syndrome (NMS): This a potentially fatal complication associated with Zyprexa. Symptoms include: irregular pulse, altered mental state, muscle tightness and rigidity, and irregular blood pressure.
  • Hyperglycemia (High Blood Sugar): Symbyax may lead to high blood sugar in adults and children, which has the potential to lead to Type 2 diabetes.
  • Hyperlipidemia (High Cholesterol and Triglycerides: Studies suggest that Symbyax increased triglyceride levels to as much as 500 milligrams per deciliter. It is also known to increase cholesterol.
  • Serotonin Syndrome: A potentially fatal condition that occurs when the body makes too much serotonin.
  • Tardive dyskinesia: A disorder associated with antipsychotic drugs that causes involuntary muscle movements similar to Parkinson’s disease.
  1. FDA (2009) “Symbyax Medication Guide”
  2. FDA (2006) “FDA Public Health Advisory: Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns.”
  3. NCBI (2006) “SSRI Antidepressants and Birth Defects”
  4. BMJ (2009) “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study”
  5. MedPage Today (2011) “More Evidence SSRIs in Pregnancy Boost Birth Defect Risk”
  6. NEJM (2007) “Use of Selective Serotonin-Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects”
  7. JAMA Pediatrics (2016) “Antidepressant Use During Pregnancy and the Risk of Autism Spectrum Disorder in Children”
Last Modified: March 3, 2016

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