WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Suicidality and Antidepressant Drugs — Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of SYMBYAX or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SYMBYAX is not approved for use in pediatric patients. [See Warnings and Precautions (5.1), Use in Specific Populations (8.4), and Patient Counseling Information (17.2)].
Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SYMBYAX (olanzapine and fluoxetine HCl) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.2, 5.18) and Patient Counseling Information (17.3)].
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SYMBYAX SUMMARY
SYMBYAX™ (olanzapine and fluoxetine HCl capsules) combines 2 psychotropic agents, olanzapine (the active ingredient in Zyprexa®, and Zyprexa Zydis®) and fluoxetine hydrochloride (the active ingredient in Prozac®, Prozac Weekly™, and Sarafem®).
SYMBYAX is indicated for the treatment of depressive episodes associated with bipolar disorder. The efficacy of SYMBYAX was established in 2 identically designed, 8-week, randomized, double-blind clinical studies.
Unlike with unipolar depression, there are no established guidelines for the length of time patients with bipolar disorder experiencing a major depressive episode should be treated with agents containing antidepressant drugs.
The effectiveness of SYMBYAX for maintaining antidepressant response in this patient population beyond 8 weeks has not been established in controlled clinical studies. Physicians who elect to use SYMBYAX for extended periods should periodically reevaluate the benefits and long-term risks of the drug for the individual patient.
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NEWS HIGHLIGHTSMedia Articles Related to Symbyax (Olanzapine / Fluoxetine)
Circadian Clock Implicated in Kids' Bipolar Disorder (CME/CE)
Source: MedPage Today Psychiatry [2009.11.12]
A faulty circadian clock could be partly to blame for the rapid mood cycles of pediatric bipolar disorder, researchers said.
Smoking tied to suicide risk in bipolar disorder (Reuters)
Source: Y! Health Depression News [2009.11.11]
Reuters - People with bipolar disorder who smoke appear to have a heightened risk of suicidal behavior -- possibly because they are generally prone to impulsive acts, a new study suggests.
Mental Health America Applauds Bipartisan Legislation To Help Treat Depression And Bipolar Disorders
Source: Bipolar News From Medical News Today [2009.10.29]
Mental Health America is applauding legislation introduced by a bipartisan group of U.S. Senators to establish national centers of excellence for the treatment of depression and bipolar disorders. The centers will create a national network to help diagnose people in need and improve access to evidence-based, quality care. The bill, called the "ENHANCED Act" was introduced by U.S. Senators Debbie Stabenow (D-Mich.
Break-through Preventative Care Program For People Living With Bipolar Disorder
Source: Bipolar News From Medical News Today [2009.10.28]
A major breakthrough in mental health has been developed, a cooperative venture between the National Bipolar Foundation and the MedicAlert Foundation; a preventative care program called "Safe 'til Stable." It provides vital medical information to emergency responders in time of need through our live 24-hour emergency response service. In a medical emergency, this can help reduce the trauma experienced by individuals impacted with bipolar disorder.
Funding Supports ADA Technologies' Development Of Home Monitor For Bipolar Disorder
Source: Bipolar News From Medical News Today [2009.10.28]
ADA Technologies, Inc. (ADA) received a $189,886 grant from the National Institute of Mental Health to develop a home lithiummonitor for use by patients with bipolar disorder. The testing tool would allow reliable, routine at-home monitoring of blood lithium concentrations, enabling individuals with bipolar disorder to conveniently and effectively manage their care. Effective treatment of bipolar disorder, an inherited disease that affects 5.
Published Studies Related to Symbyax (Olanzapine / Fluoxetine)
Effectiveness and safety of the combination of fluoxetine and olanzapine in outpatients with bipolar depression: an open-label, randomized, flexible-dose study in Puerto Rico. [2009.08]
We studied the effectiveness of olanzapine/fluoxetine combination (OFC) treatment of bipolar depressive episode (7 weeks, study period 1 [SP1]). Study period 1 responders (mean modal daily OFC dosage, 10.8/27.8 mg) were randomized to OFC continuation treatment or olanzapine (OLZ) monotherapy starting at 10 mg (12 weeks, SP2)...
Olanzapine/fluoxetine combination vs. lamotrigine in the 6-month treatment of bipolar I depression. [2009.07]
To determine the efficacy and tolerability of olanzapine/fluoxetine combination (OFC) compared with lamotrigine (Lam) for long-term treatment of bipolar I depression, this 25-wk, randomized, double-blind study compared OFC (6/25, 6/50, 12/25, or 12/50 mg/d, n=205) with Lam titrated to 200 mg/d (n=205) in patients with bipolar I disorder, depressed...
A randomized, double-blind comparison of olanzapine/fluoxetine combination, olanzapine, and fluoxetine in treatment-resistant major depressive disorder. [2007.02]
CONCLUSION: Patients with TRD (defined as treatment failure on 2 antidepressants) taking olanzapine/fluoxetine combination demonstrated significantly greater improvement in depressive symptoms than patients taking olanzapine or fluoxetine in 1 of 2 studies and in the pooled analysis. When considered within the context of all available evidence, olanzapine/fluoxetine combination is an efficacious therapy for patients with TRD. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT00035321.
A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. [2006.07]
CONCLUSIONS: Patients with acute bipolar I depression had statistically significantly greater improvement in depressive and manic symptoms, more treatment-emergent adverse events, greater weight gain, and some elevated metabolic factors with OFC than lamotrigine. Treatment differences were of modest size.
Comparison of fluoxetine, olanzapine, and combined fluoxetine plus olanzapine initial therapy of bipolar type I and type II major depression--lack of manic induction. [2005.07]
OBJECTIVE: Current guidelines for the initial treatment of bipolar type I (BP I) and bipolar type II (BP II) major depressive episode (MDE) recommend avoiding the use of antidepressant drugs due to concerns over drug-induced manic switch episodes. However, recent evidence suggests that the manic switch rate during SSRI therapy of BP MDE may be lower than previously thought. This preliminary, placebo-controlled study examines the relative rates of treatment-emergent manic symptoms during fluoxetine monotherapy, olanzapine monotherapy, and combined fluoxetine plus olanzapine therapy of BP I and BP II MDE... CONCLUSION: These observations support earlier findings of a low manic switch rate during fluoxetine monotherapy of BP I and BP II MDE, and suggest that fluoxetine may be a safe initial treatment of BP MDE alone or in combination with olanzapine.
Clinical Trials Related to Symbyax (Olanzapine / Fluoxetine)
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression [Recruiting]
The main goal of this study is to help answer the following research question(s) and not to
treat the child's illness.
- Can this study drug make children with bipolar depression feel better?
- Does this study drug work better than a placebo (sugar pill)?
- Does this study drug cause side effects in children who take it?
- Is this drug safe to use in children? (The study drug is a mixture of olanzapine and
fluoxetine)
Olanzapine in Patients With Advanced Cancer and Weight Loss [Recruiting]
Objectives:
1. 1. Primary:
1. The primary objective is to define the safety and maximum tolerated dose (MTD) of
Olanzapine in patients with weight loss and cachexia secondary to advanced cancer.
1. 2. Secondary:
1. To perform a preliminary assessment of the metabolic profile changes in patients with
advanced cancer treated at different doses of Olanzapine.
2. To outline the nutritional status and performance status changes of patients treated at
different doses of Olanzapine.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Symbyax has an overall score of 2. The effectiveness score is 2 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Symbyax review by 33 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 12.5/25 mg taken daily for the period of 4 weeks |
| Other conditions: | | obesity |
| Other drugs taken: | | lessisna | | |
Reported Results |
| Benefits: | | none, side effects that were intolerable were an increase in appetite and decreased libido |
| Side effects: | | increased appetite
decreased libidp |
| Comments: | | one pill daily at bedtime |
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Page last updated: 2009-11-12
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