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 Use in Specific Populations (8.4), and Patient Counseling Information].
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].
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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)
Bipolar Disorder (Mania) Quiz: Test Your Emotional Wellness IQ Source: MedicineNet Bipolar Disorder Specialty [2017.09.20] Title: Bipolar Disorder (Mania) Quiz: Test Your Emotional Wellness IQ Category: MedicineNet Quiz Created: 9/18/2012 1:28:00 PM Last Editorial Review: 9/20/2017 12:33:06 PM
Bipolar Disorder Source: MedicineNet aripiprazole Specialty [2017.05.30] Title: Bipolar Disorder Category: Symptoms and Signs Created: 12/6/2013 12:00:00 AM Last Editorial Review: 5/30/2017 12:00:00 AM
Bipolar Disorder vs. Schizophrenia Source: MedicineNet Schizophrenia Specialty [2017.05.18] Title: Bipolar Disorder vs. Schizophrenia Category: Diseases and Conditions Created: 5/18/2017 12:00:00 AM Last Editorial Review: 5/18/2017 12:00:00 AM
Bipolar Disorder: Symptoms, Testing for Bipolar Depression Source: MedicineNet Electroconvulsive Therapy Specialty [2016.08.05] Title: Bipolar Disorder: Symptoms, Testing for Bipolar Depression Category: Slideshows Created: 4/16/2009 12:00:00 AM Last Editorial Review: 8/5/2016 12:00:00 AM
Certain Antidepressants May Be Linked to Bipolar Disorder: Study Source: MedicineNet mirtazapine Specialty [2015.12.16] Title: Certain Antidepressants May Be Linked to Bipolar Disorder: Study Category: Health News Created: 12/15/2015 12:00:00 AM Last Editorial Review: 12/16/2015 12:00:00 AM
Published Studies Related to Symbyax (Olanzapine / Fluoxetine)
Pharmacokinetic evaluation of olanzapine + fluoxetine for the treatment of
bipolar depression. [2013] INTRODUCTION: A proprietary combination of the atypical antipsychotic drug
olanzapine and the serotonin reuptake inhibitor fluoxetine (OFC, Symbyax) was
approved for the treatment of bipolar depression based on a double-blind,
placebo-controlled comparison of olanzapine, OFC, and placebo.In the absence of comparisons to mood stabilizers combined with each other and/or
antidepressants, the role of OFC in the treatment of bipolar depression remains
unclear.
Association of common variations in the norepinephrine transporter gene with
response to olanzapine-fluoxetine combination versus continued-fluoxetine
treatment in patients with treatment-resistant depression: a candidate gene
analysis. [2012] CONCLUSIONS: Our findings further support the hypothesis that the synergistic
Genetic association study of treatment response with olanzapine/fluoxetine combination or lamotrigine in bipolar I depression. [2010.05] CONCLUSIONS: SNPs in specific candidate genes were associated with symptomatic improvement in a treatment-specific fashion. These results suggest the importance of dopaminergic effects in the treatment of patients with bipolar I depression and the potential utility of genotyping in selection of pharmacologic treatments for bipolar depression.
Genetic associations of prolactin increase in olanzapine/fluoxetine combination-treated patients. [2010.01.30] In patients from two clinical trials, we investigated the associations of single nucleotide polymorphisms (SNPs) in candidate genes with prolactin level changes during treatment with olanzapine/fluoxetine combination. In both cohorts, three dopamine receptor D2 (DRD2) SNPs were associated with prolactin changes.
Olanzapine/fluoxetine combination in patients with treatment-resistant
depression: rapid onset of therapeutic response and its predictive value for
subsequent overall response in a pooled analysis of 5 studies. [2010] CONCLUSIONS: Olanzapine/fluoxetine combination is superior to fluoxetine and
Clinical Trials Related to Symbyax (Olanzapine / Fluoxetine)
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression [Completed]
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 [Completed]
The goal of this clinical research study is to find the highest tolerable dose of the drug
Olanzapine that can be given to patients with advanced cancer who are experiencing weight
loss. Researchers want to find out if Olanzapine can help decrease weight loss in patients
who are experiencing it because of cancer. How this drug affects performance status,
cancer-related symptoms, and nutritional status in patients with advanced cancer will also
be studied.
Subcutaneous Olanzapine for Hyperactive or Mixed Delirium [Completed]
The objective of this study is to determine the tolerability and safety of olanzapine
administered as a subcutaneous injection to hospitalized patients with hyperactive or mixed
delirium.
Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics [Completed]
This study will test the effectiveness of two different treatments for children and
adolescents who have gained weight on their antipsychotic medications.
Reports of Suspected Symbyax (Olanzapine / Fluoxetine) Side Effects
OFF Label USE (7),
Asphyxia (3),
Completed Suicide (3),
Fall (2),
Suicidal Ideation (2),
Decreased Appetite (2),
Insomnia (2),
Withdrawal Syndrome (2),
Blood Bilirubin Increased (1),
Intentional Overdose (1), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Symbyax has an overall score of 4. The effectiveness score is 4 and the side effect score is 6.67. The scores are on ten point scale: 10 - best, 1 - worst.
| Symbyax review by 18 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Considerably Effective |
Side effects: | | No Side Effects | | Treatment Info |
Condition / reason: | | Bipolar disorder |
Dosage & duration: | | 6mg/25mg taken every night for the period of two months |
Other conditions: | | Schitzophrenia |
Other drugs taken: | | Seroquil | | Reported Results |
Benefits: | | The benefits were great. I really liked Symbyax because it didn't give me side effects like the other medication I used to take did. I would wake up in the day feeling refreshed. As I was taking Seroquil for my Schitzophrenia, I would always wake up feeling exhausted and tired;still, even though I would take the medicine during the nights! I used to be stressed and aggravated all the time before Symbyax and Seroquil. Now that I'm on Symbyax, I'm emotionally numb and the voices in my head vanished. So I had a good nights sleep and didn't wake up as tired as Seroquil used to make me. :] |
Side effects: | | I didn't really have many side effects besides the medicine making me want to go to sleep. But I'm not complaining, since it does help the voices and the shadows go away for a while. Besides that, my psychiatrist wanted me to take advantage of the other side effect, and that side effect is that Symbyax might make you gain a little weight. So I wouldn't suggest it to people who want to lose weight. I still didn't seen any change in the weight gain and it was about a month when I started taking the lowest dose of Symbyax. Now that that month is over, I just started taking a higher dosage and I have noticed an increase in my appetite. I recommend this drug for the depressed ones who are a little underweight and the Schitzophrenics. |
Comments: | | As I was being diagnosed for my Bipolar disorder, I would say the medication did more for me than my therapist. The drug, Symbyax, made me more calm than I have ever been. It took about a week for the medicine to kick in and when it did, it really did work its magic even though Seroquil was pretty good at knocking me out to sleep, it didn't help me with my anxiety and depression like Symbyax has. |
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| Symbyax review by 20 year old male patient | | Rating |
Overall rating: | | |
Effectiveness: | | Ineffective |
Side effects: | | Moderate Side Effects | | Treatment Info |
Condition / reason: | | depression |
Dosage & duration: | | 6/25 12/25 (dosage frequency: 6/25 in the morning 12/25 at night) for the period of one year |
Other conditions: | | anxiety |
Other drugs taken: | | n/a | | Reported Results |
Benefits: | | the benefits were i was still depressed but not as bad and anything was better then that all in all i should of had the anti bipolar med the damn doc thought i was bipolar |
Side effects: | | i had a racing heart beat but extreme tiredness really strage it was the worst thing i had experianced took my mind off being depressed but i didnt know any diffrent It was the first anti depressant iv ever taken i thought it was supposed to be like that |
Comments: | | i think this med sould be for very severe bipolar and depression combonation or i probably should of took the bear minimum dose it mite of worked but not for me |
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| Symbyax review by 20 year old male patient | | Rating |
Overall rating: | | |
Effectiveness: | | Ineffective |
Side effects: | | Moderate Side Effects | | Treatment Info |
Condition / reason: | | depression |
Dosage & duration: | | 6/25 12/25 (dosage frequency: 6/25 in the morning 12/25 at night) for the period of one year |
Other conditions: | | anxiety |
Other drugs taken: | | n/a | | Reported Results |
Benefits: | | the benefits were i was still depressed but not as bad and anything was better then that all in all i should of had the anti bipolar med the damn doc thought i was bipolar |
Side effects: | | i had a racing heart beat but extreme tiredness really strage it was the worst thing i had experianced took my mind off being depressed but i didnt know any diffrent It was the first anti depressant iv ever taken i thought it was supposed to be like that |
Comments: | | i think this med sould be for very severe bipolar and depression combonation or i probably should of took the bear minimum dose it mite of worked but not for me |
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Page last updated: 2017-09-20
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